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API & FDP development and manufacturing of a BCG immunotherapy product

  • Contract manufacturing, filling and packaging
  • Biopharmaceuticals
  • Worldwide
  • 11/28/2018

Description

On behalf of one of my customers who wants to stay confidential at this stage, I am looking for a CDMO to develop a manufacturing process and subsequently manufacture a Mycobacterium bovis BCG based API and drug product. The strain is selected and available; the task would be to perform the process development (surface culture preferred but submerged culture also possible) and subsequently manufacture the product under EU GMP compliant framework. There is no clinical trials involved; the customer will use the first development batch for comparability reasons and after authority approval use commercial product immediately.

Requirements

  • experience in development of bacterial strains
  • EU GMP certificate for commercial production

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