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 and Risk assessment based upon whole genome sequencing analysis, to show that they will pose no risk to our ongoing projects and our personnel. This is a necessary requirement for all GMP facilities.
- Strain isolation and characterization: This is a complex step involving several activities. It starts with screening, and then the specific strain(s) must be isolated starting from a sample. Various techniques can be used but here at Biose Industrie we have developed a proprietary understanding (genetic analysis) using rep-PCR, quantitative PCR, full genome sequencing, RNAseq, comparison of metabolic pathway activation and / or gene integration. After this step comes in vitro characterization of the strains, including resistance to biological substances (such as bile and gastric pH) and sensitivity to antibiotics / antifungals. Finally, Biose Industrie guides clients through the development and validation of the analytical methods transfer.