Clean Cells has worked for several years to implement GMP standards for the manufacture and quality control testing of bacteriophage cocktails and their in-process material notably through the involvement in the Phagoburn consortium.
In this context, our company is in a preferential position to propose relevant services for the generation of all the material needed to manufacture a safe phage-based product:
- Microbial cell banks (R&D grade, GMP grade)
- Phage stocks (R&D grade, GMP grade)
- Drug substance (single phage)
- Drug product (phage cocktail)
Bacteriophage manufacturing activities occur in a GMP-qualified grade “A in C” room and are supported by a strict environmental monitoring and validated cleaning procedures.
GMP-compliant storage and QC testing can be proposed in association with banking.
Please do not hesitate to reach out to our team to evaluate your bacteriophage-related project