What are typical workpackages of a GMP manufacturing project?

A typical manufacturing project consists of the following phases/work packages:

  • Cell banking: GMP Master Cell Bank
  • Feasibility Study: Development of expression strain, manufacturing process, analytical methods à non-GMP run à optional: delivery non-GMP (pre-clinical) material to client
  • GMP preparation: GMP transfer & Scale-up, GMP documentation à Engineering run à optional: delivery pre-GMP product to client (e.g. for Tox studies)
  • GMP manufacturing: GMP drug substance (API), GMP drug product (IMP), critical starting materials (e.g. for AAV vector based gene therapy), linear DNA template for mRNA manufacturing.

Other workpackages like stability studies or regulatory support can be agreed.