The company employs scalable and transferable raw materials, process technologies, and analytical tests compliant with cGMP manufacturing. Its core processes include fermentation, purification, formulation, and analytical testing. Fermentation utilizes microscale screening to optimize bacterial strains and scale-up procedures, sourcing strains from unique research cell bank precursors. Purification begins at a small scale but is designed for scalability, focusing on oral dosage forms containing spores or live bacteria, which facilitates separation compared to parenteral biologics. Formulation development emphasizes oral delivery using approved excipients and preservatives to achieve stability with minimal cold-chain requirements. Analytical methods comprise proprietary microbiological, chemical, biochemical, and molecular sequence-based tests to verify quality control, identity, potency, and purity. Manufacturing operations are based in Cambridge, Massachusetts.
Seres Therapeutics Inc's Comment on Supply Chain
The company employs scalable and transferable raw materials, process technologies, and analytical tests compliant with cGMP manufacturing. Its core processes include fermentation, purification, formulation, and analytical testing. Fermentation utilizes microscale screening to optimize bacterial strains and scale-up procedures, sourcing strains from unique research cell bank precursors. Purification begins at a small scale but is designed for scalability, focusing on oral dosage forms containing spores or live bacteria, which facilitates separation compared to parenteral biologics. Formulation development emphasizes oral delivery using approved excipients and preservatives to achieve stability with minimal cold-chain requirements. Analytical methods comprise proprietary microbiological, chemical, biochemical, and molecular sequence-based tests to verify quality control, identity, potency, and purity. Manufacturing operations are based in Cambridge, Massachusetts.
Sources:
Seres Therapeutics Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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