GMP Drug Substance Development: Selecting a process appropriate to the strain(s)

22 June 2021

GMP Drug Substance Development is an important part of product development for clients of Biose Industrie. Our team members are expert problem solvers who ensure the manufacturing consistently outputs a live biotherapeutic product to certain quality specifications, while documenting all steps in the process.

Several stages are involved:

  1. Selecting a process appropriate to the strain(s)
  2. Cell banking and
  3. Fermentation, Concentration and Freeze drying

Biose Industrie’s facility has two dedicated GMP areas—one for clinical production (phase 1 – 3 clinical trials) and another for large-scale production for lactobacilli. By late 2022, extra capacity will be added to keep up with demand. The factory expansion plans will double the maximum volumes for the company.

Selecting a process appropriate to the strain(s)

In the first part of the GMP Drug Substance process, the Biose Industrie team guides the client in selecting the process that is suitable for the microbes being used in the product. Options include:

  • Fully anaerobic upstream production process

Strict anaerobic bacteria are notoriously challenging to manufacture, but not only does Biose Industrie offer a fully anaerobic upstream production process, it is also the first CDMO for Live Biotherapeutics to offer high-volume manufacturing for strict anaerobes. The company has developed industrial processes that enable us to maintain oxygen-free conditions from the inoculation process through to lyophilisation.

  • Novel co-culture techniques

Biose Industrie has been at the forefront of the science, supporting a number of projects working on novel co-culture solutions. When successful, these techniques can bring a big advantage in the long run for multi-strain production processes.

  • Techniques for GMO strains or spore forming bacteria

Additional safety precautions must be taken for both genetically modified organisms (GMOs) and spore forming bacteria. Thanks to the excellent knowledge the company has developed in cleaning and disinfection technologies, Biose Industrie can manage any type of GMO strain up to GMO BSL 2 on its main GMP lines.

Furthermore, the company’s main GMP lines are designed for the complexity of manufacturing spore forming bacteria. Biose Industrie has developed strong technologies that enable us to understand spore forming strains and control them throughout manufacturing.