Purchase of Formulation development and GMP manufacture of tablets for early clinical development
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- Qualification deadline
- 3. maiExpired
- Procedure
- Without prior noticeTwo stages
- Agreement
- Buying services
Brief
Danmarks Tekniske Universitet - DTU har til hensigt at indgå en aftale med Porton Pharmaceutical Chemicals GmbH om køb af formuleringudvikling og GMP-fremstilling af tabletter til tidlig klinisk udvikling. Aftalen omfatter specialiserede farmaceutiske udviklings- og fremstillingstjenester, der er nødvendige for at muliggøre et "first-in-human" klinisk studie inden for Microbiome Health Initiative (MHI). Tjenesterne inkluderer formuleringudvikling, analytisk metodeudvikling og validering, ikke-GMP og GMP-fremstilling af en oral fast doseringsform (tabletter), stabilitetsstudier og udarbejdelse af dokumentation til støtte for lovgivningsmæssige indsendelser (IND/IMPD). Arbejdet dækker den fulde IND-aktiverende lægemiddelpakke for en ny lille-molekylær forbindelse inden for galdesyreklassen, beregnet til brug i et fase I human interventionsstudie. Den endelige kontraktværdi er 185.530 €.
Forskning og utdanning
Result
- Porton Pharmaceutical Chemicals GmbHWinner
- 0Number of bids
- €185,530Contract value
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From the notice
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. The services are highly specialized, research- and development-driven, and closely linked to the specific and regulatory requirements of the project.
Contact
Pia Blumepiabl@dtu.dk- Result · PrequalificationType
- 73110000Main codeResearch services