Kalaris Therapeutics Inc's Comment on Supply Chain
The company utilizes contract manufacturers for the production of its product candidate for clinical trials and potential commercial manufacturing. The primary contract manufacturers are STC Biologics, Inc. and Sharp Sterile Manufacturing (formerly Berkshire Sterile Manufacturing Inc.). KBI Biopharma, located in North Carolina, acts as the Contract Development and Manufacturing Organization (CDMO) for future clinical and commercial supply manufacturing of the TH103 drug substance. The company is currently selecting a CDMO partner for manufacturing the TH103 drug product. TH103 is produced through biological manufacturing processes involving Chinese hamster ovary K1 cells and recombinant DNA technology. The company depends on third parties for packaging, labeling, storage, and distribution of TH103 and intends to maintain this reliance if marketing approval is obtained. This approach supports maintaining an efficient infrastructure while focusing resources on clinical development and commercialization.
Kalaris Therapeutics Inc's Comment on Supply Chain
The company utilizes contract manufacturers for the production of its product candidate for clinical trials and potential commercial manufacturing. The primary contract manufacturers are STC Biologics, Inc. and Sharp Sterile Manufacturing (formerly Berkshire Sterile Manufacturing Inc.). KBI Biopharma, located in North Carolina, acts as the Contract Development and Manufacturing Organization (CDMO) for future clinical and commercial supply manufacturing of the TH103 drug substance. The company is currently selecting a CDMO partner for manufacturing the TH103 drug product. TH103 is produced through biological manufacturing processes involving Chinese hamster ovary K1 cells and recombinant DNA technology. The company depends on third parties for packaging, labeling, storage, and distribution of TH103 and intends to maintain this reliance if marketing approval is obtained. This approach supports maintaining an efficient infrastructure while focusing resources on clinical development and commercialization.
Sources:
Kalaris 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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