GMP Drug Substance Part 3: Fermentation, Concentration and Freeze Drying

19 October 2021

Development and production of the API (active pharmaceutical ingredient) is key for the future activity of the drug product. Fermentation, concentration and freeze drying (lyophilisation) are all necessary in the GMP Drug Substance process to arrive at the finished product.

Our team always encourages clients to have their process validated with at least one engineering run prior to the actual GMP run.

Fermentation

Biose Industrie offers many options for fermentation, with something to suit the needs of every client. Available equipment is as follows:

  • ENG : 150L – Centrifugation with plates or nozzle technologies or TFF Filtration
  • DS1: 20L, 300L and 3 500L – Centrifugation with plates or nozzle technologies or TFF Filtration
  • DS2 : 2000L line for commercial manufacturing of Lactobacillus strains
  • DS3 : 800L x4 line for commercial manufacturing of Lactobacillus strains
  • DS4: 150L – Centrifugation with plates or nozzle technologies
  • DS5 : 20L, 200L and 2000L – Centrifugation with plates or nozzle technologies
  • DS6 : 50, 500L and 5000L – Centrifugation with plates or nozzle technologies
Freeze drying

Biose Industrie are world-leading experts in lyophilisation, having decades of experience in helping clients with this process for their products. In fact, for many years the company was called ‘Lyocentre’ because of our expertise in lyophilisation. In 2020, the company had 22 commercial or clinical batches released by our QP (PharmD). Biose Industrie also has a placebo formulation developed internally.