{"bekendtgoerelseNoegle":{"noticeId":{"value":"78e8ed0a-005c-4d84-a79e-dd4b097a830b"},"noticeVersion":{"value":"01"},"noticePublicationNumber":{"value":"00083506-2024"}},"htmlDA":"<!DOCTYPE HTML>\n<html xmlns:cac=\"urn:oasis:names:specification:ubl:schema:xsd:CommonAggregateComponents-2\" xmlns:cbc=\"urn:oasis:names:specification:ubl:schema:xsd:CommonBasicComponents-2\" xmlns:efac=\"http://data.europa.eu/p27/eforms-ubl-extension-aggregate-components/1\" xmlns:efbc=\"http://data.europa.eu/p27/eforms-ubl-extension-basic-components/1\" xmlns:efext=\"http://data.europa.eu/p27/eforms-ubl-extensions/1\" xmlns:ext=\"urn:oasis:names:specification:ubl:schema:xsd:CommonExtensionComponents-2\" xmlns:fn=\"http://www.w3.org/2005/xpath-functions\" xmlns:xs=\"http://www.w3.org/2001/XMLSchema\">\n   <body>\n      <section>1&nbsp;<span class=\"label\">Køber</span><section>1.1&nbsp;<span class=\"label\">Køber</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Region Midtjylland</span></section>\n            <section><span class=\"label\">Køberens retlige status</span><span class=\"text\">: </span><span class=\"dynamic-label\">Regional myndighed</span></section>\n            <section><span class=\"label\">Den ordregivende myndigheds aktiviteter</span><span class=\"text\">: </span><span class=\"dynamic-label\">Sundhed</span></section>\n         </section>\n      </section>\n      <section>2&nbsp;<span class=\"label\">Procedure</span><section>2.1&nbsp;<span class=\"label\">Procedure</span><section><span class=\"label\">Titel</span><span class=\"text\">: </span><span class=\"value\">Delivery of two Bioreactors</span></section>\n            <section><span class=\"label\">Beskrivelse</span><span class=\"text\">: </span><span class=\"value\">The department of Immunology wish to purchase two bioractors with the following specifications:\n                  1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration\n                  of conformity to CE to indicate its conformity with health, safety, and environmental\n                  protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing\n                  capabilities to enable data collection, analysis, and process control. This may include\n                  connectivity to a software system for real-time monitoring and control. 3. In-Process\n                  Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor\n                  and control critical culture parameters; at least temperature, pH, dissolved oxygen.\n                  And preferably the option include more parameters such as (inline) nutrient sensors.\n                  The monitoring system must allow for real-time data access and alarms for out-of-range\n                  conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate\n                  continuous volume expandable scalability, allowing for easy scale-up or scale-out\n                  of the cell culture process (not based on successively using bioreactors of increasing\n                  size). Especially the bioreactor must allow the initiation of the cell culture process\n                  with a relatively small amount of starting material (e.g. such as cell isolated directly\n                  from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate\n                  a sampling port or system that allows for direct and sterile sampling of the cell\n                  culture without disrupting the process integrity. This feature enables the analysis\n                  of cell culture parameters and product quality during the culture period. 6. Expansion\n                  Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent\n                  cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance\n                  of quality and safety standards throughout the cell expansion process. 7. Viability\n                  and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize\n                  cell viability and purity of the resulting cellular products. This must involve features\n                  such as controlled cell detachment mechanisms, gentle agitation methods (preferably\n                  lack of headspace, provides a low-shear environment), and provisions for downstream\n                  processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant\n                  Procedures: The bioreactor must support GMP-compliant cell harvesting procedures,\n                  which must include the implementation of automated, closed-system cell harvesting\n                  techniques to maintain sterility, and product integrity. 9. Flexibility in application:\n                  The bioreactor must support the cultivation of multiple cell types to ensure it can\n                  accommodate future developments in the field. It ideally allows cultivation of both\n                  adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic\n                  stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of\n                  contamination and reduce cost/effort for cleaning and sterilization, cells must be\n                  cultured in single-use bags with minimal installation requirements.</span></section>\n            <section><span class=\"label\">Identifikator for proceduren</span><span class=\"text\">: </span><span class=\"value\">593b0e3c-ade1-4b41-97cd-dfe0ded47142</span></section>\n            <section><span class=\"label\">Intern identifikator</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n            <section><span class=\"label\">Udbudsprocedure</span><span class=\"text\">: </span><span class=\"dynamic-label\">Udbud med forhandling uden forudgående offentliggørelse</span></section>\n            <section>2.1.1&nbsp;<span class=\"label\">Formål</span><section><span class=\"label\">Kontraktens art</span><span class=\"text\">: </span><span class=\"dynamic-label\">Varer</span></section>\n               <section><span class=\"label\">Yderligere om kontraktens art</span><span class=\"text\">: </span><span class=\"dynamic-label\">Tjenesteydelser</span></section>\n               <section><span class=\"label\">Primær klassificering</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">cpv</span><span class=\"text\">): </span><span class=\"value\">33000000</span><span class=\"text\"> </span><span class=\"dynamic-label\">Medicinsk udstyr, lægemidler og produkter til personlig pleje</span></section>\n            </section>\n            <section>2.1.2&nbsp;<span class=\"label\">Udførelsessted</span><section><span class=\"label\">Landespecifik underafdeling (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Østjylland</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">DK042</span><span class=\"text\">)</span></section>\n               <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Danmark</span></section>\n               <section><span class=\"label\">Yderligere oplysninger</span><span class=\"text\">: </span><span class=\"value\">Aarhus University Hospital</span></section>\n            </section>\n            <section>2.1.4&nbsp;<span class=\"label\">Generelle oplysninger</span><section><span class=\"label\">Retsgrundlag</span><span class=\"text\">:</span></section>\n               <section><span class=\"dynamic-label\">Direktiv 2014/24/EU</span></section>\n            </section>\n         </section>\n      </section>\n      <section>5&nbsp;<span class=\"label\">Delkontrakt</span><section>5.1&nbsp;<span class=\"label\">Teknisk ID for partiet</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span><section><span class=\"label\">Titel</span><span class=\"text\">: </span><span class=\"value\">delivery of Bioreactor</span></section>\n            <section><span class=\"label\">Beskrivelse</span><span class=\"text\">: </span><span class=\"value\">The department of Immunology wish to purchase two bioractors with the following specifications:\n                  1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration\n                  of conformity to CE to indicate its conformity with health, safety, and environmental\n                  protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing\n                  capabilities to enable data collection, analysis, and process control. This may include\n                  connectivity to a software system for real-time monitoring and control. 3. In-Process\n                  Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor\n                  and control critical culture parameters; at least temperature, pH, dissolved oxygen.\n                  And preferably the option include more parameters such as (inline) nutrient sensors.\n                  The monitoring system must allow for real-time data access and alarms for out-of-range\n                  conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate\n                  continuous volume expandable scalability, allowing for easy scale-up or scale-out\n                  of the cell culture process (not based on successively using bioreactors of increasing\n                  size). Especially the bioreactor must allow the initiation of the cell culture process\n                  with a relatively small amount of starting material (e.g. such as cell isolated directly\n                  from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate\n                  a sampling port or system that allows for direct and sterile sampling of the cell\n                  culture without disrupting the process integrity. This feature enables the analysis\n                  of cell culture parameters and product quality during the culture period. 6. Expansion\n                  Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent\n                  cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance\n                  of quality and safety standards throughout the cell expansion process. 7. Viability\n                  and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize\n                  cell viability and purity of the resulting cellular products. This must involve features\n                  such as controlled cell detachment mechanisms, gentle agitation methods (preferably\n                  lack of headspace, provides a low-shear environment), and provisions for downstream\n                  processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant\n                  Procedures: The bioreactor must support GMP-compliant cell harvesting procedures,\n                  which must include the implementation of automated, closed-system cell harvesting\n                  techniques to maintain sterility, and product integrity. 9. Flexibility in application:\n                  The bioreactor must support the cultivation of multiple cell types to ensure it can\n                  accommodate future developments in the field. It ideally allows cultivation of both\n                  adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic\n                  stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of\n                  contamination and reduce cost/effort for cleaning and sterilization, cells must be\n                  cultured in single-use bags with minimal installation requirements.</span></section>\n            <section><span class=\"label\">Intern identifikator</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n            <section>5.1.1&nbsp;<span class=\"label\">Formål</span><section><span class=\"label\">Kontraktens art</span><span class=\"text\">: </span><span class=\"dynamic-label\">Varer</span></section>\n               <section><span class=\"label\">Yderligere om kontraktens art</span><span class=\"text\">: </span><span class=\"dynamic-label\">Tjenesteydelser</span></section>\n               <section><span class=\"label\">Primær klassificering</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">cpv</span><span class=\"text\">): </span><span class=\"value\">33000000</span><span class=\"text\"> </span><span class=\"dynamic-label\">Medicinsk udstyr, lægemidler og produkter til personlig pleje</span></section>\n            </section>\n            <section>5.1.2&nbsp;<span class=\"label\">Udførelsessted</span><section><span class=\"label\">Landespecifik underafdeling (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Østjylland</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">DK042</span><span class=\"text\">)</span></section>\n               <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Danmark</span></section>\n               <section><span class=\"label\">Yderligere oplysninger</span><span class=\"text\">: </span><span class=\"value\">Aarhus University Hospital</span></section>\n            </section>\n            <section>5.1.6&nbsp;<span class=\"label\">Generelle oplysninger</span><section><span class=\"dynamic-label\">Indkøbsprojekt, der ikke finansieres med EU-midler</span></section>\n               <section><span class=\"label\">Udbuddet er omfattet af aftalen om offentlige udbud (GPA)</span><span class=\"text\">: </span><span class=\"label\">ja</span></section>\n            </section>\n            <section>5.1.12&nbsp;<span class=\"label\">Udbudsvilkår</span><section><span class=\"label\">Oplysninger om undersøgelsesfrister</span><span class=\"text\">: </span><span class=\"value\">Kontrakten vil ikke blive indgået før udløb af en standstill periode på 10 dage regnet\n                     fra dagen efter offentliggørelse af denne profylaksebekendtgørelse, jf. § 4, stk.\n                     1, nr. 2 i lov om Klagenævnet for Udbud (LBK nr. 593 af 2.6.2016) – tilgængelig på\n                     www.retsinformation.dk. Klage indgives til Klagenævnet for Udbud: Senest samtidig\n                     med, at en klage indgives til Klagenævnet for Udbud, skal klageren skriftligt underrette\n                     Region Midtjylland om, at klage indgives til Klagenævnet for Udbud, og om klagen er\n                     indgivet i standstill perioden, jf. lovens § 6, stk. 4. Efter underskrift af kontrakten\n                     vil Region Midtjylland offentliggøre en tildelingsbekendtgørelse, hvilket vil indlede\n                     en klagefrist. Nærmere information om klagefristen vil følge af tildelingsbekendtgørelsen.\n                     Klagenævnet for Udbuds egen klagevejledning er tilgængelig på Klager over udbud (kfst.dk)</span></section>\n            </section>\n            <section>5.1.16&nbsp;<span class=\"label\">Yderligere oplysninger, mægling og gennemgang</span><section><span class=\"label\">Organisation med ansvar for klager</span><span class=\"text\">: </span><span class=\"value\">Klagenævnet for Udbud</span></section>\n               <section><span class=\"label\">Organisation, der leverer yderligere oplysninger om klageprocedurerne</span><span class=\"text\">: </span><span class=\"value\">Konkurrence- og Forbrugerstyrelsen</span></section>\n               <section><span class=\"label\">TED eSender</span><span class=\"text\">: </span><span class=\"value\">Mercell Holding ASA</span></section>\n            </section>\n         </section>\n      </section>\n      <section>6&nbsp;<span class=\"label\">Resultater</span><section><span class=\"label\">Værdien af alle kontrakter tildelt i denne meddelelse</span><span class=\"text\">: </span><span class=\"value\">250.000</span><span class=\"text\"> </span><span class=\"label\">Euro</span></section>\n         <section><span class=\"label\">Direkte tildeling</span><span class=\"text\">:</span><section><span class=\"label\">Begrundelse for direkte tildeling</span><span class=\"text\">: </span><span class=\"dynamic-label\">Kontrakten kan kun tildeles af en bestemt økonomisk aktør på grund af manglende konkurrence af tekniske årsager</span></section>\n            <section><span class=\"label\">Anden begrundelse</span><span class=\"text\">: </span><span class=\"value\">Due to the above, the buyer intends to enter into a contract with Scinus Cell Expansion\n                  for the delivery of two bioreactors as the acquisition is covered by the ruled on\n                  tenders with negotiation without prior tender notice, jf. § 80, section 3, no. 2 of\n                  the Danish Public Procurement Act as the contract can only be assigned to one specific\n                  economic actor for technical reasons. According to the buyer's market coverage, there\n                  are no other players on the market who can solve the requirements described above.</span></section>\n         </section>\n         <section>6.1&nbsp;<span class=\"label\">Resultat delkontrakt-ID</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span><section>6.1.2&nbsp;<span class=\"label\">Oplysninger om vinderne</span><section><span class=\"label\">Vinder</span><span class=\"text\">:</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Scinus Cell Expansion</span></section>\n                  <section><span class=\"label\">Tilbud</span><span class=\"text\">:</span></section>\n                  <section><span class=\"label\">Tilbud – Identifikator</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n                  <section><span class=\"label\">Identifikator for delkontrakt eller gruppe af delkontrakter</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span></section>\n                  <section><span class=\"label\">Underentrepriseværdien er kendt</span><span class=\"text\">: </span><span class=\"label\">nej</span></section>\n                  <section><span class=\"label\">Underentrepriseprocentdelen er kendt</span><span class=\"text\">: </span><span class=\"label\">nej</span></section>\n                  <section><span class=\"label\">Kontraktoplysninger</span><span class=\"text\">:</span><section><span class=\"label\">Identifikator for kontrakten</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n                     <section><span class=\"label\">Titel</span><span class=\"text\">: </span><span class=\"value\">Delivery of two bioreactors</span></section>\n                     <section><span class=\"label\">Kontrakten tildeles som led i en rammeaftale</span><span class=\"text\">: </span><span class=\"label\">nej</span></section>\n                  </section>\n               </section>\n            </section>\n         </section>\n      </section>\n      <section>8&nbsp;<span class=\"label\">Organisationer</span><section>8.1&nbsp;<span class=\"value\">ORG-0001</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Region Midtjylland</span></section>\n            <section><span class=\"label\">Registreringsnummer</span><span class=\"text\">: </span><span class=\"value\">29190925</span></section>\n            <section><span class=\"label\">Afdeling</span><span class=\"text\">: </span><span class=\"value\">Indkøb &amp; Medicoteknik</span></section>\n            <section><span class=\"label\">Postadresse</span><span class=\"text\">: </span><span class=\"value\">Olof Palmes Allé 15</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">By</span><span class=\"text\">: </span><span class=\"value\">Aarhus N</span></section>\n            <section><span class=\"label\">Postnummer</span><span class=\"text\">: </span><span class=\"value\">8200</span></section>\n            <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Danmark</span></section>\n            <section><span class=\"label\">Kontaktpunkt</span><span class=\"text\">: </span><span class=\"value\">Camilla de Gier</span></section>\n            <section><span class=\"label\">E-mail</span><span class=\"text\">: </span><span class=\"value\">camilla.degier@stab.rm.dk</span></section>\n            <section><span class=\"label\">Telefon</span><span class=\"text\">: </span><span class=\"value\">+45 61126240</span></section>\n            <section><span class=\"label\">Internetadresse</span><span class=\"text\">: </span><span class=\"value\">https://www.udbud.rm.dk</span></section>\n            <section><span class=\"label\">Køberprofil</span><span class=\"text\">: </span><span class=\"value\">https://eu.eu-supply.com/ctm/company/companyinformation/index/253854</span></section>\n            <section><span class=\"label\">Denne organisations roller</span><span class=\"text\">:</span><section><span class=\"label\">Køber</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0002</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Klagenævnet for Udbud</span></section>\n            <section><span class=\"label\">Postadresse</span><span class=\"text\">: </span><span class=\"value\">Nævnenes Hus, Tolboden 2</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">By</span><span class=\"text\">: </span><span class=\"value\">Viborg</span></section>\n            <section><span class=\"label\">Postnummer</span><span class=\"text\">: </span><span class=\"value\">8800</span></section>\n            <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Danmark</span></section>\n            <section><span class=\"label\">E-mail</span><span class=\"text\">: </span><span class=\"value\">klfu@naevneneshus.dk</span></section>\n            <section><span class=\"label\">Telefon</span><span class=\"text\">: </span><span class=\"value\">+45 72405708</span></section>\n            <section><span class=\"label\">Denne organisations roller</span><span class=\"text\">:</span><section><span class=\"label\">Organisation med ansvar for klager</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0003</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Konkurrence- og Forbrugerstyrelsen</span></section>\n            <section><span class=\"label\">Postadresse</span><span class=\"text\">: </span><span class=\"value\">Carl Jacobsens Vej 35</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">By</span><span class=\"text\">: </span><span class=\"value\">Valby</span></section>\n            <section><span class=\"label\">Postnummer</span><span class=\"text\">: </span><span class=\"value\">2500</span></section>\n            <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Danmark</span></section>\n            <section><span class=\"label\">E-mail</span><span class=\"text\">: </span><span class=\"value\">kfst@kfst.dk</span></section>\n            <section><span class=\"label\">Telefon</span><span class=\"text\">: </span><span class=\"value\">+45 41715000</span></section>\n            <section><span class=\"label\">Denne organisations roller</span><span class=\"text\">:</span><section><span class=\"label\">Organisation, der leverer yderligere oplysninger om klageprocedurerne</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0004</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Scinus Cell Expansion</span></section>\n            <section><span class=\"label\">Den økonomiske operatørs størrelse</span><span class=\"text\">: </span><span class=\"label\">Lille virksomhed</span></section>\n            <section><span class=\"label\">Postadresse</span><span class=\"text\">: </span><span class=\"value\">Prof. Bronkhorstlaan 10, bld 48</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">By</span><span class=\"text\">: </span><span class=\"value\">Bilthoven</span></section>\n            <section><span class=\"label\">Postnummer</span><span class=\"text\">: </span><span class=\"value\">3723 MB</span></section>\n            <section><span class=\"label\">Landespecifik underafdeling (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Utrecht</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">NL310</span><span class=\"text\">)</span></section>\n            <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Nederlandene</span></section>\n            <section><span class=\"label\">E-mail</span><span class=\"text\">: </span><span class=\"value\">info@scinus.com</span></section>\n            <section><span class=\"label\">Telefon</span><span class=\"text\">: </span><span class=\"value\">+310850509300</span></section>\n            <section><span class=\"label\">Denne organisations roller</span><span class=\"text\">:</span><section><span class=\"label\">Tilbudsgiver</span></section>\n               <section><span class=\"label\">Vinder af disse delkontrakter</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0005</span><section><span class=\"label\">Officielt navn</span><span class=\"text\">: </span><span class=\"value\">Mercell Holding ASA</span></section>\n            <section><span class=\"label\">Registreringsnummer</span><span class=\"text\">: </span><span class=\"value\">980921565</span></section>\n            <section><span class=\"label\">Postadresse</span><span class=\"text\">: </span><span class=\"value\">Askekroken 11</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">By</span><span class=\"text\">: </span><span class=\"value\">Oslo</span></section>\n            <section><span class=\"label\">Postnummer</span><span class=\"text\">: </span><span class=\"value\">0277</span></section>\n            <section><span class=\"label\">Landespecifik underafdeling (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Oslo</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">NO081</span><span class=\"text\">)</span></section>\n            <section><span class=\"label\">Land</span><span class=\"text\">: </span><span class=\"dynamic-label\">Norge</span></section>\n            <section><span class=\"label\">Kontaktpunkt</span><span class=\"text\">: </span><span class=\"value\">eSender</span></section>\n            <section><span class=\"label\">E-mail</span><span class=\"text\">: </span><span class=\"value\">publication@mercell.com</span></section>\n            <section><span class=\"label\">Telefon</span><span class=\"text\">: </span><span class=\"value\">+47 21018800</span></section>\n            <section><span class=\"label\">Fax</span><span class=\"text\">: </span><span class=\"value\">+47 21018801</span></section>\n            <section><span class=\"label\">Internetadresse</span><span class=\"text\">: </span><span class=\"value\">http://mercell.com/</span></section>\n            <section><span class=\"label\">Denne organisations roller</span><span class=\"text\">:</span><section><span class=\"label\">TED eSender</span></section>\n            </section>\n         </section>\n      </section>\n      <section>11&nbsp;<span class=\"label\">Oplysninger om bekendtgørelsen</span><section>11.1&nbsp;<span class=\"label\">Oplysninger om bekendtgørelsen</span><section><span class=\"label\">Identifikator for bekendtgørelsen</span><span class=\"text\">: </span><span class=\"value\">78e8ed0a-005c-4d84-a79e-dd4b097a830b</span><span class=\"text\"> </span><span class=\"text\">- </span><span class=\"value\">01</span></section>\n            <section><span class=\"label\">Formulartype</span><span class=\"text\">: </span><span class=\"dynamic-label\">Forudgående underretning om direkte tildeling</span></section>\n            <section><span class=\"label\">Bekendtgørelsestype</span><span class=\"text\">: </span><span class=\"dynamic-label\">Bekendtgørelse med henblik på frivillig forudgående gennemsigtighed</span></section>\n            <section><span class=\"label\">Afsendelsesdato for bekendtgørelsen</span><span class=\"text\">: </span><span class=\"value\">07-02-2024</span><span class=\"text\"> </span><span class=\"value\">10:48 +00:00</span></section>\n            <section><span class=\"label\">Dato for afsendelse af bekendtgørelse (eSender)</span><span class=\"text\">: </span><span class=\"value\">07-02-2024</span><span class=\"text\"> </span><span class=\"value\">10:48 +00:00</span></section>\n            <section><span class=\"label\">Sprog, som denne bekendtgørelse er officielt tilgængelig på</span><span class=\"text\">: </span><span class=\"dynamic-label\">dansk</span><span class=\"text\"> </span><span class=\"dynamic-label\"></span></section>\n         </section>\n         <section>11.2&nbsp;<span class=\"label\">Oplysninger om offentliggørelsen</span><section><span class=\"label\">Bekendtgørelsesnummer</span><span class=\"text\">: </span><span class=\"value\">00083506-2024</span></section>\n            <section><span class=\"label\">EUT-S-nummer</span><span class=\"text\">: </span><span class=\"value\">28/2024</span></section>\n            <section><span class=\"label\">Offentliggørelsesdato</span><span class=\"text\">: </span><span class=\"value\">08-02-2024</span></section>\n         </section>\n      </section>\n   </body>\n</html>","htmlEN":"<!DOCTYPE HTML>\n<html xmlns:cac=\"urn:oasis:names:specification:ubl:schema:xsd:CommonAggregateComponents-2\" xmlns:cbc=\"urn:oasis:names:specification:ubl:schema:xsd:CommonBasicComponents-2\" xmlns:efac=\"http://data.europa.eu/p27/eforms-ubl-extension-aggregate-components/1\" xmlns:efbc=\"http://data.europa.eu/p27/eforms-ubl-extension-basic-components/1\" xmlns:efext=\"http://data.europa.eu/p27/eforms-ubl-extensions/1\" xmlns:ext=\"urn:oasis:names:specification:ubl:schema:xsd:CommonExtensionComponents-2\" xmlns:fn=\"http://www.w3.org/2005/xpath-functions\" xmlns:xs=\"http://www.w3.org/2001/XMLSchema\">\n   <body>\n      <section>1&nbsp;<span class=\"label\">Buyer</span><section>1.1&nbsp;<span class=\"label\">Buyer</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Region Midtjylland</span></section>\n            <section><span class=\"label\">Legal type of the buyer</span><span class=\"text\">: </span><span class=\"dynamic-label\">Regional authority</span></section>\n            <section><span class=\"label\">Activity of the contracting authority</span><span class=\"text\">: </span><span class=\"dynamic-label\">Health</span></section>\n         </section>\n      </section>\n      <section>2&nbsp;<span class=\"label\">Procedure</span><section>2.1&nbsp;<span class=\"label\">Procedure</span><section><span class=\"label\">Title</span><span class=\"text\">: </span><span class=\"value\">Delivery of two Bioreactors</span></section>\n            <section><span class=\"label\">Description</span><span class=\"text\">: </span><span class=\"value\">The department of Immunology wish to purchase two bioractors with the following specifications:\n                  1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration\n                  of conformity to CE to indicate its conformity with health, safety, and environmental\n                  protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing\n                  capabilities to enable data collection, analysis, and process control. This may include\n                  connectivity to a software system for real-time monitoring and control. 3. In-Process\n                  Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor\n                  and control critical culture parameters; at least temperature, pH, dissolved oxygen.\n                  And preferably the option include more parameters such as (inline) nutrient sensors.\n                  The monitoring system must allow for real-time data access and alarms for out-of-range\n                  conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate\n                  continuous volume expandable scalability, allowing for easy scale-up or scale-out\n                  of the cell culture process (not based on successively using bioreactors of increasing\n                  size). Especially the bioreactor must allow the initiation of the cell culture process\n                  with a relatively small amount of starting material (e.g. such as cell isolated directly\n                  from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate\n                  a sampling port or system that allows for direct and sterile sampling of the cell\n                  culture without disrupting the process integrity. This feature enables the analysis\n                  of cell culture parameters and product quality during the culture period. 6. Expansion\n                  Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent\n                  cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance\n                  of quality and safety standards throughout the cell expansion process. 7. Viability\n                  and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize\n                  cell viability and purity of the resulting cellular products. This must involve features\n                  such as controlled cell detachment mechanisms, gentle agitation methods (preferably\n                  lack of headspace, provides a low-shear environment), and provisions for downstream\n                  processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant\n                  Procedures: The bioreactor must support GMP-compliant cell harvesting procedures,\n                  which must include the implementation of automated, closed-system cell harvesting\n                  techniques to maintain sterility, and product integrity. 9. Flexibility in application:\n                  The bioreactor must support the cultivation of multiple cell types to ensure it can\n                  accommodate future developments in the field. It ideally allows cultivation of both\n                  adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic\n                  stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of\n                  contamination and reduce cost/effort for cleaning and sterilization, cells must be\n                  cultured in single-use bags with minimal installation requirements.</span></section>\n            <section><span class=\"label\">Procedure identifier</span><span class=\"text\">: </span><span class=\"value\">593b0e3c-ade1-4b41-97cd-dfe0ded47142</span></section>\n            <section><span class=\"label\">Internal identifier</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n            <section><span class=\"label\">Type of procedure</span><span class=\"text\">: </span><span class=\"dynamic-label\">Negotiated without prior call for competition</span></section>\n            <section>2.1.1&nbsp;<span class=\"label\">Purpose</span><section><span class=\"label\">Main nature of the contract</span><span class=\"text\">: </span><span class=\"dynamic-label\">Supplies</span></section>\n               <section><span class=\"label\">Additional nature of the contract</span><span class=\"text\">: </span><span class=\"dynamic-label\">Services</span></section>\n               <section><span class=\"label\">Main classification</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">cpv</span><span class=\"text\">): </span><span class=\"value\">33000000</span><span class=\"text\"> </span><span class=\"dynamic-label\">Medical equipments, pharmaceuticals and personal care products</span></section>\n            </section>\n            <section>2.1.2&nbsp;<span class=\"label\">Place of performance</span><section><span class=\"label\">Country subdivision (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Østjylland</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">DK042</span><span class=\"text\">)</span></section>\n               <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Denmark</span></section>\n               <section><span class=\"label\">Additional information</span><span class=\"text\">: </span><span class=\"value\">Aarhus University Hospital</span></section>\n            </section>\n            <section>2.1.4&nbsp;<span class=\"label\">General information</span><section><span class=\"label\">Legal basis</span><span class=\"text\">:</span></section>\n               <section><span class=\"dynamic-label\">Directive 2014/24/EU</span></section>\n            </section>\n         </section>\n      </section>\n      <section>5&nbsp;<span class=\"label\">Lot</span><section>5.1&nbsp;<span class=\"label\">Lot technical ID</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span><section><span class=\"label\">Title</span><span class=\"text\">: </span><span class=\"value\">delivery of Bioreactor</span></section>\n            <section><span class=\"label\">Description</span><span class=\"text\">: </span><span class=\"value\">The department of Immunology wish to purchase two bioractors with the following specifications:\n                  1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration\n                  of conformity to CE to indicate its conformity with health, safety, and environmental\n                  protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing\n                  capabilities to enable data collection, analysis, and process control. This may include\n                  connectivity to a software system for real-time monitoring and control. 3. In-Process\n                  Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor\n                  and control critical culture parameters; at least temperature, pH, dissolved oxygen.\n                  And preferably the option include more parameters such as (inline) nutrient sensors.\n                  The monitoring system must allow for real-time data access and alarms for out-of-range\n                  conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate\n                  continuous volume expandable scalability, allowing for easy scale-up or scale-out\n                  of the cell culture process (not based on successively using bioreactors of increasing\n                  size). Especially the bioreactor must allow the initiation of the cell culture process\n                  with a relatively small amount of starting material (e.g. such as cell isolated directly\n                  from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate\n                  a sampling port or system that allows for direct and sterile sampling of the cell\n                  culture without disrupting the process integrity. This feature enables the analysis\n                  of cell culture parameters and product quality during the culture period. 6. Expansion\n                  Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent\n                  cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance\n                  of quality and safety standards throughout the cell expansion process. 7. Viability\n                  and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize\n                  cell viability and purity of the resulting cellular products. This must involve features\n                  such as controlled cell detachment mechanisms, gentle agitation methods (preferably\n                  lack of headspace, provides a low-shear environment), and provisions for downstream\n                  processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant\n                  Procedures: The bioreactor must support GMP-compliant cell harvesting procedures,\n                  which must include the implementation of automated, closed-system cell harvesting\n                  techniques to maintain sterility, and product integrity. 9. Flexibility in application:\n                  The bioreactor must support the cultivation of multiple cell types to ensure it can\n                  accommodate future developments in the field. It ideally allows cultivation of both\n                  adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic\n                  stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of\n                  contamination and reduce cost/effort for cleaning and sterilization, cells must be\n                  cultured in single-use bags with minimal installation requirements.</span></section>\n            <section><span class=\"label\">Internal identifier</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n            <section>5.1.1&nbsp;<span class=\"label\">Purpose</span><section><span class=\"label\">Main nature of the contract</span><span class=\"text\">: </span><span class=\"dynamic-label\">Supplies</span></section>\n               <section><span class=\"label\">Additional nature of the contract</span><span class=\"text\">: </span><span class=\"dynamic-label\">Services</span></section>\n               <section><span class=\"label\">Main classification</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">cpv</span><span class=\"text\">): </span><span class=\"value\">33000000</span><span class=\"text\"> </span><span class=\"dynamic-label\">Medical equipments, pharmaceuticals and personal care products</span></section>\n            </section>\n            <section>5.1.2&nbsp;<span class=\"label\">Place of performance</span><section><span class=\"label\">Country subdivision (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Østjylland</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">DK042</span><span class=\"text\">)</span></section>\n               <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Denmark</span></section>\n               <section><span class=\"label\">Additional information</span><span class=\"text\">: </span><span class=\"value\">Aarhus University Hospital</span></section>\n            </section>\n            <section>5.1.6&nbsp;<span class=\"label\">General information</span><section><span class=\"dynamic-label\">Procurement Project not financed with EU Funds.</span></section>\n               <section><span class=\"label\">The procurement is covered by the Government Procurement Agreement (GPA)</span><span class=\"text\">: </span><span class=\"label\">yes</span></section>\n            </section>\n            <section>5.1.12&nbsp;<span class=\"label\">Terms of procurement</span><section><span class=\"label\">Information about review deadlines</span><span class=\"text\">: </span><span class=\"value\">Kontrakten vil ikke blive indgået før udløb af en standstill periode på 10 dage regnet\n                     fra dagen efter offentliggørelse af denne profylaksebekendtgørelse, jf. § 4, stk.\n                     1, nr. 2 i lov om Klagenævnet for Udbud (LBK nr. 593 af 2.6.2016) – tilgængelig på\n                     www.retsinformation.dk. Klage indgives til Klagenævnet for Udbud: Senest samtidig\n                     med, at en klage indgives til Klagenævnet for Udbud, skal klageren skriftligt underrette\n                     Region Midtjylland om, at klage indgives til Klagenævnet for Udbud, og om klagen er\n                     indgivet i standstill perioden, jf. lovens § 6, stk. 4. Efter underskrift af kontrakten\n                     vil Region Midtjylland offentliggøre en tildelingsbekendtgørelse, hvilket vil indlede\n                     en klagefrist. Nærmere information om klagefristen vil følge af tildelingsbekendtgørelsen.\n                     Klagenævnet for Udbuds egen klagevejledning er tilgængelig på Klager over udbud (kfst.dk)</span></section>\n            </section>\n            <section>5.1.16&nbsp;<span class=\"label\">Further information, mediation and review</span><section><span class=\"label\">Review organisation</span><span class=\"text\">: </span><span class=\"value\">Klagenævnet for Udbud</span></section>\n               <section><span class=\"label\">Organisation providing more information on the review procedures</span><span class=\"text\">: </span><span class=\"value\">Konkurrence- og Forbrugerstyrelsen</span></section>\n               <section><span class=\"label\">TED eSender</span><span class=\"text\">: </span><span class=\"value\">Mercell Holding ASA</span></section>\n            </section>\n         </section>\n      </section>\n      <section>6&nbsp;<span class=\"label\">Results</span><section><span class=\"label\">Value of all contracts awarded in this notice</span><span class=\"text\">: </span><span class=\"value\">250.000</span><span class=\"text\"> </span><span class=\"label\">Euro</span></section>\n         <section><span class=\"label\">Direct award</span><span class=\"text\">:</span><section><span class=\"label\">Justification for direct award</span><span class=\"text\">: </span><span class=\"dynamic-label\">The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons</span></section>\n            <section><span class=\"label\">Other justification</span><span class=\"text\">: </span><span class=\"value\">Due to the above, the buyer intends to enter into a contract with Scinus Cell Expansion\n                  for the delivery of two bioreactors as the acquisition is covered by the ruled on\n                  tenders with negotiation without prior tender notice, jf. § 80, section 3, no. 2 of\n                  the Danish Public Procurement Act as the contract can only be assigned to one specific\n                  economic actor for technical reasons. According to the buyer's market coverage, there\n                  are no other players on the market who can solve the requirements described above.</span></section>\n         </section>\n         <section>6.1&nbsp;<span class=\"label\">Result lot ldentifier</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span><section>6.1.2&nbsp;<span class=\"label\">Information about winners</span><section><span class=\"label\">Winner</span><span class=\"text\">:</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Scinus Cell Expansion</span></section>\n                  <section><span class=\"label\">Tender</span><span class=\"text\">:</span></section>\n                  <section><span class=\"label\">Tender identifier</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n                  <section><span class=\"label\">Identifier of lot or group of lots</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span></section>\n                  <section><span class=\"label\">Subcontracting value is known</span><span class=\"text\">: </span><span class=\"label\">no</span></section>\n                  <section><span class=\"label\">Subcontracting percentage is known</span><span class=\"text\">: </span><span class=\"label\">no</span></section>\n                  <section><span class=\"label\">Contract information</span><span class=\"text\">:</span><section><span class=\"label\">Identifier of the contract</span><span class=\"text\">: </span><span class=\"value\">1-23-4-72-6-24</span></section>\n                     <section><span class=\"label\">Title</span><span class=\"text\">: </span><span class=\"value\">Delivery of two bioreactors</span></section>\n                     <section><span class=\"label\">The contract is awarded within a framework agreement</span><span class=\"text\">: </span><span class=\"label\">no</span></section>\n                  </section>\n               </section>\n            </section>\n         </section>\n      </section>\n      <section>8&nbsp;<span class=\"label\">Organisations</span><section>8.1&nbsp;<span class=\"value\">ORG-0001</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Region Midtjylland</span></section>\n            <section><span class=\"label\">Registration number</span><span class=\"text\">: </span><span class=\"value\">29190925</span></section>\n            <section><span class=\"label\">Department</span><span class=\"text\">: </span><span class=\"value\">Indkøb &amp; Medicoteknik</span></section>\n            <section><span class=\"label\">Postal address</span><span class=\"text\">: </span><span class=\"value\">Olof Palmes Allé 15</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">Town</span><span class=\"text\">: </span><span class=\"value\">Aarhus N</span></section>\n            <section><span class=\"label\">Postcode</span><span class=\"text\">: </span><span class=\"value\">8200</span></section>\n            <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Denmark</span></section>\n            <section><span class=\"label\">Contact point</span><span class=\"text\">: </span><span class=\"value\">Camilla de Gier</span></section>\n            <section><span class=\"label\">Email</span><span class=\"text\">: </span><span class=\"value\">camilla.degier@stab.rm.dk</span></section>\n            <section><span class=\"label\">Telephone</span><span class=\"text\">: </span><span class=\"value\">+45 61126240</span></section>\n            <section><span class=\"label\">Internet address</span><span class=\"text\">: </span><span class=\"value\">https://www.udbud.rm.dk</span></section>\n            <section><span class=\"label\">Buyer profile</span><span class=\"text\">: </span><span class=\"value\">https://eu.eu-supply.com/ctm/company/companyinformation/index/253854</span></section>\n            <section><span class=\"label\">Roles of this organisation</span><span class=\"text\">:</span><section><span class=\"label\">Buyer</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0002</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Klagenævnet for Udbud</span></section>\n            <section><span class=\"label\">Postal address</span><span class=\"text\">: </span><span class=\"value\">Nævnenes Hus, Tolboden 2</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">Town</span><span class=\"text\">: </span><span class=\"value\">Viborg</span></section>\n            <section><span class=\"label\">Postcode</span><span class=\"text\">: </span><span class=\"value\">8800</span></section>\n            <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Denmark</span></section>\n            <section><span class=\"label\">Email</span><span class=\"text\">: </span><span class=\"value\">klfu@naevneneshus.dk</span></section>\n            <section><span class=\"label\">Telephone</span><span class=\"text\">: </span><span class=\"value\">+45 72405708</span></section>\n            <section><span class=\"label\">Roles of this organisation</span><span class=\"text\">:</span><section><span class=\"label\">Review organisation</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0003</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Konkurrence- og Forbrugerstyrelsen</span></section>\n            <section><span class=\"label\">Postal address</span><span class=\"text\">: </span><span class=\"value\">Carl Jacobsens Vej 35</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">Town</span><span class=\"text\">: </span><span class=\"value\">Valby</span></section>\n            <section><span class=\"label\">Postcode</span><span class=\"text\">: </span><span class=\"value\">2500</span></section>\n            <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Denmark</span></section>\n            <section><span class=\"label\">Email</span><span class=\"text\">: </span><span class=\"value\">kfst@kfst.dk</span></section>\n            <section><span class=\"label\">Telephone</span><span class=\"text\">: </span><span class=\"value\">+45 41715000</span></section>\n            <section><span class=\"label\">Roles of this organisation</span><span class=\"text\">:</span><section><span class=\"label\">Organisation providing more information on the review procedures</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0004</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Scinus Cell Expansion</span></section>\n            <section><span class=\"label\">Size of the economic operator</span><span class=\"text\">: </span><span class=\"label\">Small</span></section>\n            <section><span class=\"label\">Postal address</span><span class=\"text\">: </span><span class=\"value\">Prof. Bronkhorstlaan 10, bld 48</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">Town</span><span class=\"text\">: </span><span class=\"value\">Bilthoven</span></section>\n            <section><span class=\"label\">Postcode</span><span class=\"text\">: </span><span class=\"value\">3723 MB</span></section>\n            <section><span class=\"label\">Country subdivision (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Utrecht</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">NL310</span><span class=\"text\">)</span></section>\n            <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Netherlands</span></section>\n            <section><span class=\"label\">Email</span><span class=\"text\">: </span><span class=\"value\">info@scinus.com</span></section>\n            <section><span class=\"label\">Telephone</span><span class=\"text\">: </span><span class=\"value\">+310850509300</span></section>\n            <section><span class=\"label\">Roles of this organisation</span><span class=\"text\">:</span><section><span class=\"label\">Tenderer</span></section>\n               <section><span class=\"label\">Winner of these lots</span><span class=\"text\">: </span><span class=\"value\">LOT-0000</span></section>\n            </section>\n         </section>\n         <section>8.1&nbsp;<span class=\"value\">ORG-0005</span><section><span class=\"label\">Official name</span><span class=\"text\">: </span><span class=\"value\">Mercell Holding ASA</span></section>\n            <section><span class=\"label\">Registration number</span><span class=\"text\">: </span><span class=\"value\">980921565</span></section>\n            <section><span class=\"label\">Postal address</span><span class=\"text\">: </span><span class=\"value\">Askekroken 11</span><span class=\"text\"> </span><span class=\"value\"></span><span class=\"text\"> </span><span class=\"value\"></span></section>\n            <section><span class=\"label\">Town</span><span class=\"text\">: </span><span class=\"value\">Oslo</span></section>\n            <section><span class=\"label\">Postcode</span><span class=\"text\">: </span><span class=\"value\">0277</span></section>\n            <section><span class=\"label\">Country subdivision (NUTS)</span><span class=\"text\">: </span><span class=\"dynamic-label\">Oslo</span><span class=\"text\"> </span><span class=\"text\">(</span><span class=\"value\">NO081</span><span class=\"text\">)</span></section>\n            <section><span class=\"label\">Country</span><span class=\"text\">: </span><span class=\"dynamic-label\">Norway</span></section>\n            <section><span class=\"label\">Contact point</span><span class=\"text\">: </span><span class=\"value\">eSender</span></section>\n            <section><span class=\"label\">Email</span><span class=\"text\">: </span><span class=\"value\">publication@mercell.com</span></section>\n            <section><span class=\"label\">Telephone</span><span class=\"text\">: </span><span class=\"value\">+47 21018800</span></section>\n            <section><span class=\"label\">Fax</span><span class=\"text\">: </span><span class=\"value\">+47 21018801</span></section>\n            <section><span class=\"label\">Internet address</span><span class=\"text\">: </span><span class=\"value\">http://mercell.com/</span></section>\n            <section><span class=\"label\">Roles of this organisation</span><span class=\"text\">:</span><section><span class=\"label\">TED eSender</span></section>\n            </section>\n         </section>\n      </section>\n      <section>11&nbsp;<span class=\"label\">Notice information</span><section>11.1&nbsp;<span class=\"label\">Notice information</span><section><span class=\"label\">Notice identifier/version</span><span class=\"text\">: </span><span class=\"value\">78e8ed0a-005c-4d84-a79e-dd4b097a830b</span><span class=\"text\"> </span><span class=\"text\">- </span><span class=\"value\">01</span></section>\n            <section><span class=\"label\">Form type</span><span class=\"text\">: </span><span class=\"dynamic-label\">Direct award preannouncement</span></section>\n            <section><span class=\"label\">Notice type</span><span class=\"text\">: </span><span class=\"dynamic-label\">Voluntary ex-ante transparency notice</span></section>\n            <section><span class=\"label\">Notice dispatch date</span><span class=\"text\">: </span><span class=\"value\">07-02-2024</span><span class=\"text\"> </span><span class=\"value\">10:48 +00:00</span></section>\n            <section><span class=\"label\">Notice dispatch date (eSender)</span><span class=\"text\">: </span><span class=\"value\">07-02-2024</span><span class=\"text\"> </span><span class=\"value\">10:48 +00:00</span></section>\n            <section><span class=\"label\">Languages in which this notice is officially available</span><span class=\"text\">: </span><span class=\"dynamic-label\">Danish</span><span class=\"text\"> </span><span class=\"dynamic-label\"></span></section>\n         </section>\n         <section>11.2&nbsp;<span class=\"label\">Publication information</span><section><span class=\"label\">Notice publication number</span><span class=\"text\">: </span><span class=\"value\">00083506-2024</span></section>\n            <section><span class=\"label\">OJ S issue number</span><span class=\"text\">: </span><span class=\"value\">28/2024</span></section>\n            <section><span class=\"label\">Publication date</span><span class=\"text\">: </span><span class=\"value\">08-02-2024</span></section>\n         </section>\n      </section>\n   </body>\n</html>","opsummeringDA":{"card":{"titel":"Delivery of two Bioreactors","ordregiver":"Region Midtjylland","ordregiverId":"29190925","ordregiverIdDatavasket":"29190925","publiceringsdato":"2024-02-08Z","cpvKode":"33000000","cpvTitel":"Medicinsk udstyr, lægemidler og produkter til personlig pleje","formulartype":"Forudgående underretning om direkte tildeling","formulartypeKode":"dir-awa-pre","tidsfrister":[],"alleOrdregivere":["Region Midtjylland"],"beskrivelse":"The department of Immunology wish to purchase two bioractors with the following specifications:  1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration of conformity to CE to indicate its conformity with health, safety, and environmental protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing capabilities to enable data collection, analysis, and process control. This may include connectivity to a software system for real-time monitoring and control. 3. In-Process Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor and control critical culture parameters; at least temperature, pH, dissolved oxygen. And preferably the option include more parameters such as (inline) nutrient sensors. The monitoring system must allow for real-time data access and alarms for out-of-range conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate continuous volume expandable scalability, allowing for easy scale-up or scale-out of the cell culture process (not based on successively using bioreactors of increasing size). Especially the bioreactor must allow the initiation of the cell culture process with a relatively small amount of starting material (e.g. such as cell isolated directly from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate a sampling port or system that allows for direct and sterile sampling of the cell culture without disrupting the process integrity. This feature enables the analysis of cell culture parameters and product quality during the culture period. 6. Expansion Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance of quality and safety standards throughout the cell expansion process. 7. Viability and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize cell viability and purity of the resulting cellular products. This must involve features such as controlled cell detachment mechanisms, gentle agitation methods (preferably lack of headspace, provides a low-shear environment), and provisions for downstream processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant Procedures: The bioreactor must support GMP-compliant cell harvesting procedures, which must include the implementation of automated, closed-system cell harvesting techniques to maintain sterility, and product integrity. 9. Flexibility in application: The bioreactor must support the cultivation of multiple cell types to ensure it can accommodate future developments in the field. It ideally allows cultivation of both adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of contamination and reduce cost/effort for cleaning and sterilization, cells must be cultured in single-use bags with minimal installation requirements. ","bkSubTypeKode":"25","bkSubType":"Bekendtgørelse med henblik på frivillig forudgående gennemsigtighed – det generelle direktiv","erAendring":false},"indholdsType":"HENTET_FRA_TED","sekundaereOrdregivere":[],"udforelsesstedNutsCode":["DK042"],"udforelsesstedSubLand":["Østjylland"],"udforelsesstedLand":["Danmark"],"udforelsesstedBy":[],"tilbudsfrister":[],"intressentfrister":[],"deltagelsefrister":[],"antalParts":0,"antalLots":1,"udbudsDokumenter":[]},"opsummeringEN":{"card":{"titel":"Delivery of two Bioreactors","ordregiver":"Region Midtjylland","ordregiverId":"29190925","ordregiverIdDatavasket":"29190925","publiceringsdato":"2024-02-08Z","cpvKode":"33000000","cpvTitel":"Medical equipments, pharmaceuticals and personal care products","formulartype":"Direct award preannouncement","formulartypeKode":"dir-awa-pre","tidsfrister":[],"alleOrdregivere":["Region Midtjylland"],"beskrivelse":"The department of Immunology wish to purchase two bioractors with the following specifications:  1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration of conformity to CE to indicate its conformity with health, safety, and environmental protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing capabilities to enable data collection, analysis, and process control. This may include connectivity to a software system for real-time monitoring and control. 3. In-Process Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor and control critical culture parameters; at least temperature, pH, dissolved oxygen. And preferably the option include more parameters such as (inline) nutrient sensors. The monitoring system must allow for real-time data access and alarms for out-of-range conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate continuous volume expandable scalability, allowing for easy scale-up or scale-out of the cell culture process (not based on successively using bioreactors of increasing size). Especially the bioreactor must allow the initiation of the cell culture process with a relatively small amount of starting material (e.g. such as cell isolated directly from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate a sampling port or system that allows for direct and sterile sampling of the cell culture without disrupting the process integrity. This feature enables the analysis of cell culture parameters and product quality during the culture period. 6. Expansion Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance of quality and safety standards throughout the cell expansion process. 7. Viability and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize cell viability and purity of the resulting cellular products. This must involve features such as controlled cell detachment mechanisms, gentle agitation methods (preferably lack of headspace, provides a low-shear environment), and provisions for downstream processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant Procedures: The bioreactor must support GMP-compliant cell harvesting procedures, which must include the implementation of automated, closed-system cell harvesting techniques to maintain sterility, and product integrity. 9. Flexibility in application: The bioreactor must support the cultivation of multiple cell types to ensure it can accommodate future developments in the field. It ideally allows cultivation of both adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of contamination and reduce cost/effort for cleaning and sterilization, cells must be cultured in single-use bags with minimal installation requirements. ","bkSubTypeKode":"25","bkSubType":"Voluntary ex-ante transparency notice – general directive","erAendring":false},"indholdsType":"HENTET_FRA_TED","sekundaereOrdregivere":[],"udforelsesstedNutsCode":["DK042"],"udforelsesstedSubLand":["Østjylland"],"udforelsesstedLand":["Denmark"],"udforelsesstedBy":[],"tilbudsfrister":[],"intressentfrister":[],"deltagelsefrister":[],"antalParts":0,"antalLots":1,"udbudsDokumenter":[]}}