{"bekendtgoerelseNoegle":{"noticeId":{"value":"18c33dc6-db55-40ef-bbf4-e443b0ff76c3"},"noticeVersion":{"value":"01"},"noticePublicationNumber":{"value":"00310830-2026"}},"htmlDA":"\n\n \n 1 Køber1.1 KøberOfficielt navn: Danmarks Tekniske Universitet - DTU\n Køberens retlige status: Offentligretligt organ\n Den ordregivende myndigheds aktivitet: Uddannelse\n \n \n 2 Procedure2.1 ProcedureTitel: Purchase of Formulation development and GMP manufacture of tablets for early clinical\n development\n Beskrivelse: DTU intends to purchase Formulation development and GMP manufacture of tablets for\n early clinical development from Porton Pharmaceutical Chemicals GmbH. The acquisition\n concerns specialized pharmaceutical development and manufacturing services required\n to enable a first-in-human clinical study within the Microbiome Health Initiative\n (MHI). The services include formulation development, analytical method development\n and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets),\n stability studies, and preparation of documentation to support regulatory submissions\n (IND/IMPD). The work covers the full IND-enabling drug product package for a novel\n small-molecule compound within the bile acid class, intended for use in a Phase I\n human intervention study. The services are highly specialized, research- and development-driven,\n and closely linked to the specific and regulatory requirements of the project.\n Identifikator for proceduren: 5d948ed8-1f35-40c3-9b27-4eef3da5a5dc\n \n Udbudsprocedure: Udbud med forhandling uden forudgående offentliggørelse\n 2.1.1 FormålKontraktens hovedformål: Tjenesteydelser\n Supplerende kontrakttype: Varer\n Primær klassifikation (cpv): 73110000 Forskning\n \n \n 2.1.4 Generelle oplysninger\n \n \n \n \n 5 Delkontrakt5.1 Delkontrakt: LOT-0000Titel: Purchase of Formulation development and GMP manufacture of tablets for early clinical\n development\n Beskrivelse: DTU intends to purchase Formulation development and GMP manufacture of tablets for\n early clinical development from Porton Pharmaceutical Chemicals GmbH. The acquisition\n concerns specialized pharmaceutical development and manufacturing services required\n to enable a first-in-human clinical study within the Microbiome Health Initiative\n (MHI). The services include formulation development, analytical method development\n and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets),\n stability studies, and preparation of documentation to support regulatory submissions\n (IND/IMPD). The work covers the full IND-enabling drug product package for a novel\n small-molecule compound within the bile acid class, intended for use in a Phase I\n human intervention study. The services are highly specialized, research- and development-driven,\n and closely linked to the specific and regulatory requirements of the project.\n \n 5.1.1 FormålKontraktens hovedformål: Tjenesteydelser\n Supplerende kontrakttype: Varer\n Primær klassifikation (cpv): 73110000 Forskning\n \n 5.1.2 Udførelsessted\n \n \n 5.1.6 Generelle oplysningerUdbuddet er omfattet af aftalen om offentlige udbud (GPA): ja\n \n 5.1.16 Yderligere oplysninger, mægling og gennemgangOrganisation med ansvar for mægling: Konkurrence- og Forbrugerstyrelsen\n Organisation med ansvar for klager: Klagenævnet for Udbud\n Organisation, der leverer yderligere oplysninger om klageprocedurerne: Danmarks Tekniske Universitet - DTU\n \n \n \n 6 ResultaterVærdien af alle kontrakter tildelt i denne bekendtgørelse: 185.530 Euro\n Direkte tildeling:Begrundelse for direkte tildeling: Kontrakten kan kun tildeles af en bestemt økonomisk aktør på grund af manglende konkurrence af tekniske årsager\n Anden begrundelse: Prior to selecting Porton Pharmaceutical Chemicals GmbH, DTU Food carried out a targeted\n market assessment to identify potential suppliers capable of supporting the IND enabling\n activities required for this project.
As part of this assessment, several CDMOs\n were approached in December 2025 and January 2026 for preliminary discussions on their\n general capabilities and interest in the scope. These included Eurofins CDMO, SGS\n Pharma, Seda, HWI Pharma Services GmbH, and Bioneer. The discussions were exploratory\n in nature and aimed at understanding overall technical fit and feasibility.
Based\n on this assessment, Porton Pharmaceutical Chemicals GmbH was selected due to a combination\n of technical, practical, and project specific considerations. In particular, Porton\n demonstrated a clear and realistic approach to supporting an integrated scope covering\n formulation development of a delayed release oral tablet, non GMP and GMP manufacturing\n for early phase clinical use, ICH compliant stability studies, and preparation of\n documentation relevant for IND/IMPD submissions.
A key consideration for the project\n is the sourcing, handling, and processing of the active pharmaceutical ingredient,\n which presents specific technical and operational challenges. Porton presented a well\n defined and feasible strategy addressing this aspect, providing confidence in their\n ability to deliver the required services within the project timelines and budget.
Furthermore,\n one of the partner institutions within the Microbiome Health Initiative has prior\n experience working with Porton on a comparable early phase development project, with\n positive outcomes. This experience, combined with DTU’s internal expertise in pharmaceutical\n development and CDMO collaborations, supported the assessment that Porton represents\n a reliable and suitable supplier for this highly specialized service.\n \n 6.1 Resultat delkontrakt-ID: LOT-00006.1.2 Oplysninger om vinderneVinder:Officielt navn: Porton Pharmaceutical Chemicals GmbH\n \n Tilbud – Identifikator: 10954 - Purchase of Formulation development and GMP manufacture of tablets for early\n clinical development\n ID for delkontrakt eller gruppe af delkontrakter: LOT-0000\n Kontraktoplysninger:Identifikator for kontrakten: 10954 - Purchase of Formulation development and GMP manufacture of tablets for early\n clinical development\n \n \n \n \n \n 8 Organisationer8.1 ORG-0001Officielt navn: Danmarks Tekniske Universitet - DTU\n Registreringsnummer: 30060946\n Postadresse: Anker Engelunds Vej 1 \n \n \n Landsdel (NUTS): Københavns omegn (DK012)\n \n \n \n \n Internetadresse: https://www.dtu.dk\n Køberprofil: https://eu.eu-supply.com/ctm/company/companyinformation/index/165863\n Denne organisations roller:\n Organisation, der leverer yderligere oplysninger om klageprocedurerne\n \n \n 8.1 ORG-0002Officielt navn: Klagenævnet for Udbud\n Registreringsnummer: 37795526\n Postadresse: Nævnenes hus, Toldboden 2 \n \n \n Landsdel (NUTS): Østjylland (DK042)\n \n \n \n Internetadresse: http://www.klfu.dk\n Denne organisations roller:Organisation med ansvar for klager\n \n \n 8.1 ORG-0003Officielt navn: Konkurrence- og Forbrugerstyrelsen\n Registreringsnummer: 10294819\n Postadresse: Carl Jacobsens Vej 35 \n \n \n Landsdel (NUTS): Byen København (DK011)\n \n \n \n Internetadresse: http://www.kfst.dk\n Denne organisations roller:Organisation med ansvar for mægling\n \n \n 8.1 ORG-0004Officielt navn: Porton Pharmaceutical Chemicals GmbH\n \n \n Landsdel (NUTS): Luzern (CH061)\n \n Denne organisations roller:\n Vinder af disse delkontrakter: LOT-0000\n \n \n 8.1 ORG-0005Officielt navn: Mercell Holding ASA\n Registreringsnummer: 980921565\n Postadresse: Askekroken 11 \n \n \n Landsdel (NUTS): Oslo (NO081)\n \n \n E-mail: publication@mercell.com\n \n \n Internetadresse: http://mercell.com/\n Denne organisations roller:\n \n \n \n Oplysninger om bekendtgørelsenBekendtgørelsens ID: 18c33dc6-db55-40ef-bbf4-e443b0ff76c3 - 01\n Formulartype: Forudgående underretning om direkte tildeling\n Bekendtgørelsestype: Bekendtgørelse med henblik på frivillig forudgående gennemsigtighed\n Afsendelsesdato for bekendtgørelsen: 04-05-2026 13:23 +00:00\n Dato for afsendelse af bekendtgørelsen (eSender): 04-05-2026 14:00 +00:00\n Bekendtgørelsens officielle sprog: engelsk \n Bekendtgørelsesnummer: 00310830-2026\n \n Offentliggørelsesdato: 06-05-2026\n \n \n","htmlEN":"\n\n \n 1 Buyer1.1 BuyerOfficial name: Danmarks Tekniske Universitet - DTU\n Legal type of the buyer: Body governed by public law\n Activity of the contracting authority: Education\n \n \n 2 Procedure2.1 ProcedureTitle: Purchase of Formulation development and GMP manufacture of tablets for early clinical\n development\n Description: DTU intends to purchase Formulation development and GMP manufacture of tablets for\n early clinical development from Porton Pharmaceutical Chemicals GmbH. The acquisition\n concerns specialized pharmaceutical development and manufacturing services required\n to enable a first-in-human clinical study within the Microbiome Health Initiative\n (MHI). The services include formulation development, analytical method development\n and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets),\n stability studies, and preparation of documentation to support regulatory submissions\n (IND/IMPD). The work covers the full IND-enabling drug product package for a novel\n small-molecule compound within the bile acid class, intended for use in a Phase I\n human intervention study. The services are highly specialized, research- and development-driven,\n and closely linked to the specific and regulatory requirements of the project.\n Procedure identifier: 5d948ed8-1f35-40c3-9b27-4eef3da5a5dc\n Internal identifier: 10954\n Type of procedure: Negotiated without prior call for competition\n 2.1.1 PurposeMain nature of the contract: Services\n Additional nature of the contract: Supplies\n Main classification (cpv): 73110000 Research services\n \n 2.1.2 Place of performance\n \n 2.1.4 General information\n \n \n \n \n 5 Lot5.1 Lot: LOT-0000Title: Purchase of Formulation development and GMP manufacture of tablets for early clinical\n development\n Description: DTU intends to purchase Formulation development and GMP manufacture of tablets for\n early clinical development from Porton Pharmaceutical Chemicals GmbH. The acquisition\n concerns specialized pharmaceutical development and manufacturing services required\n to enable a first-in-human clinical study within the Microbiome Health Initiative\n (MHI). The services include formulation development, analytical method development\n and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets),\n stability studies, and preparation of documentation to support regulatory submissions\n (IND/IMPD). The work covers the full IND-enabling drug product package for a novel\n small-molecule compound within the bile acid class, intended for use in a Phase I\n human intervention study. The services are highly specialized, research- and development-driven,\n and closely linked to the specific and regulatory requirements of the project.\n Internal identifier: 10954\n 5.1.1 PurposeMain nature of the contract: Services\n Additional nature of the contract: Supplies\n Main classification (cpv): 73110000 Research services\n \n 5.1.2 Place of performance\n \n \n 5.1.6 General informationThe procurement is covered by the Government Procurement Agreement (GPA): yes\n \n 5.1.16 Further information, mediation and reviewMediation organisation: Konkurrence- og Forbrugerstyrelsen\n Review organisation: Klagenævnet for Udbud\n Organisation providing more information on the review procedures: Danmarks Tekniske Universitet - DTU\n \n \n \n 6 ResultsValue of all contracts awarded in this notice: 185.530 Euro\n Direct award:Justification for direct award: The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons\n Other justification: Prior to selecting Porton Pharmaceutical Chemicals GmbH, DTU Food carried out a targeted\n market assessment to identify potential suppliers capable of supporting the IND enabling\n activities required for this project.
As part of this assessment, several CDMOs\n were approached in December 2025 and January 2026 for preliminary discussions on their\n general capabilities and interest in the scope. These included Eurofins CDMO, SGS\n Pharma, Seda, HWI Pharma Services GmbH, and Bioneer. The discussions were exploratory\n in nature and aimed at understanding overall technical fit and feasibility.
Based\n on this assessment, Porton Pharmaceutical Chemicals GmbH was selected due to a combination\n of technical, practical, and project specific considerations. In particular, Porton\n demonstrated a clear and realistic approach to supporting an integrated scope covering\n formulation development of a delayed release oral tablet, non GMP and GMP manufacturing\n for early phase clinical use, ICH compliant stability studies, and preparation of\n documentation relevant for IND/IMPD submissions.
A key consideration for the project\n is the sourcing, handling, and processing of the active pharmaceutical ingredient,\n which presents specific technical and operational challenges. Porton presented a well\n defined and feasible strategy addressing this aspect, providing confidence in their\n ability to deliver the required services within the project timelines and budget.
Furthermore,\n one of the partner institutions within the Microbiome Health Initiative has prior\n experience working with Porton on a comparable early phase development project, with\n positive outcomes. This experience, combined with DTU’s internal expertise in pharmaceutical\n development and CDMO collaborations, supported the assessment that Porton represents\n a reliable and suitable supplier for this highly specialized service.\n \n 6.1 Result lot identifier: LOT-00006.1.2 Information about winnersWinner:Official name: Porton Pharmaceutical Chemicals GmbH\n \n Tender identifier: 10954 - Purchase of Formulation development and GMP manufacture of tablets for early\n clinical development\n Identifier of lot or group of lots: LOT-0000\n Contract information:Identifier of the contract: 10954 - Purchase of Formulation development and GMP manufacture of tablets for early\n clinical development\n \n \n \n \n \n 8 Organisations8.1 ORG-0001Official name: Danmarks Tekniske Universitet - DTU\n Registration number: 30060946\n Postal address: Anker Engelunds Vej 1 \n \n \n Country subdivision (NUTS): Københavns omegn (DK012)\n \n \n \n \n Internet address: https://www.dtu.dk\n Buyer profile: https://eu.eu-supply.com/ctm/company/companyinformation/index/165863\n Roles of this organisation:\n Organisation providing more information on the review procedures\n \n \n 8.1 ORG-0002Official name: Klagenævnet for Udbud\n Registration number: 37795526\n Postal address: Nævnenes hus, Toldboden 2 \n \n \n Country subdivision (NUTS): Østjylland (DK042)\n \n \n \n Internet address: http://www.klfu.dk\n Roles of this organisation:\n \n \n 8.1 ORG-0003Official name: Konkurrence- og Forbrugerstyrelsen\n Registration number: 10294819\n Postal address: Carl Jacobsens Vej 35 \n \n \n Country subdivision (NUTS): Byen København (DK011)\n \n \n \n Internet address: http://www.kfst.dk\n Roles of this organisation:\n \n \n 8.1 ORG-0004Official name: Porton Pharmaceutical Chemicals GmbH\n \n \n Country subdivision (NUTS): Luzern (CH061)\n \n Roles of this organisation:\n Winner of these lots: LOT-0000\n \n \n 8.1 ORG-0005Official name: Mercell Holding ASA\n Registration number: 980921565\n Postal address: Askekroken 11 \n \n \n Country subdivision (NUTS): Oslo (NO081)\n \n \n Email: publication@mercell.com\n \n \n Internet address: http://mercell.com/\n Roles of this organisation:\n \n \n \n Notice informationNotice identifier/version: 18c33dc6-db55-40ef-bbf4-e443b0ff76c3 - 01\n Form type: Direct award preannouncement\n Notice type: Voluntary ex-ante transparency notice\n Notice dispatch date: 04-05-2026 13:23 +00:00\n Notice dispatch date (eSender): 04-05-2026 14:00 +00:00\n Languages in which this notice is officially available: English \n Notice publication number: 00310830-2026\n OJ S issue number: 87/2026\n Publication date: 06-05-2026\n \n \n","opsummeringDA":{"card":{"titel":"Purchase of Formulation development and GMP manufacture of tablets for early clinical development","ordregiver":"Danmarks Tekniske Universitet - DTU","ordregiverId":"30060946","ordregiverIdDatavasket":"30060946","publiceringsdato":"2026-05-06+02:00","cpvKode":"73110000","cpvTitel":"Forskning","formulartype":"Forudgående underretning om direkte tildeling","formulartypeKode":"dir-awa-pre","tidsfrister":[],"alleOrdregivere":["Danmarks Tekniske Universitet - DTU"],"beskrivelse":"DTU intends to purchase Formulation development and GMP manufacture of tablets for early clinical development from Porton Pharmaceutical Chemicals GmbH. The acquisition concerns specialized pharmaceutical development and manufacturing services required to enable a first-in-human clinical study within the Microbiome Health Initiative (MHI). The services include formulation development, analytical method development and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets), stability studies, and preparation of documentation to support regulatory submissions (IND/IMPD). The work covers the full IND-enabling drug product package for a novel small-molecule compound within the bile acid class, intended for use in a Phase I human intervention study. 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