GMP Manufacturing

Recombinant GMP-grade proteins and plasmids (for DNA vaccines) that are used as active pharmaceutical ingredients may be ordered at Biomay. The company specializes in the production of GMP-conform ultrapure pDNA, at batch sizes of multiple g. 

Production at Biomay takes place in state-of-the-art facilities including several clean rooms ranging from class A to D and quality control laboratories. Equipment includes a 25L bioreactor, high cell density cultivation as well as several separation, homogenization, chromatography, filtration, aseptic filling and lyophilization instruments. The equipment is generally fully qualified (IQ/OQ/PQ). Reliable contract partners are available for manufacturing drug products (aseptically filled and finished) and will be coordinated by Biomay. Deliverables include: 

  • cGMP drug substance and drug product for clinical studies (QP released, certificate of analysis, certificate of compliance)
  • Technology transfer of manufacturing processes and analytical assays
  • Documentation and reports (cell banking, development, manufacturing, quality control/release, stability)