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..Read more

After choosing microbial candidates, the next part of manufacturing a live biotherapeutic product is to understand the candidates strains at the molecular level. This involves two important steps led by Biose Industrie: Risk group assessment: All strains that enter the Biose Industrie GMP manufacturing facility have to undergo a Safety..Read more

The first step in process development for live biotherapeutic product manufacturing is to identify the microbe that will be used in the drug product and assess the conditions it needs to grow. There are several parameters that must be taken into account, as different bacteria will require different approaches. Aerobic..Read more