Once the microbial candidates have been selected and the R&D microbiology platform has been developed, clients who are developing live biotherapeutic products then move to the R&D Process Platform. This is a critical step in getting the product ready for use in clinical trials. Considerations are as follows:
- Manufacturing feasibility and process development: In partnership with the client and taking into account the client’s constraints and existing background development, Biose Industrie takes a look at the process and ensures the product manufacturing is ultimately feasible.
- Fermenters: The company undertakes a series of experimental fermentations, gradually increasing in volume (0.5L, 2L, 5L, 20L, 150L), depending on the strain(s). This serves to define the best media and help optimize other aspects of the manufacturing process.
- Centrifugation: Concentration of the biomass following the fermentation will start from 2L bioreactors and higher. This enables the team to understand how the strain reacts to potential stress during the centrifugation process. We are also well versed in using TFF or adapting TFF processes to centrifugation which gives better results on higher volume industrial lines.
- Freeze-driers: Biose Industrie helps select the appropriate lyophilization (freeze-drying) equipment: 2 x 0.5m² – 1.5m² – 4m². Lyophilization is an important part of the process for ensuring the drug product will ultimately make it to the hands of the trial participant or consumer. The correct cryoprotectants must be selected for the particular live biotherapeutic product.
- Dosage formulation:The formulation development is the final piece of the process development puzzle. Biose Industrie may help clients select the most suitable option for the final application—capsule including enteric coating and banding, tablet, stick, oil-suspension, or cream. The team’s goal is to get a product (and placebo) in hand that meet the objectives for the clinical trial.
Get in touch with Biose Industrie today to put the pieces together for your R&D Process Platform.