1. Isolation and banking of individual strains:
The manufacturing process begins with cell banks of individually isolated strains of bacteria, identified through proprietary screens as being essential members of a consortium with therapeutic potential. This approach bypasses the reliance on fecal matter donations of inconsistent composition from human donors, and eliminates the risk of pathogen transfer from such donations. We have established CGMP master cell banks for dozens of strains of gut-dwelling bacterial species and intend to significantly increase this number.