SAFC Pharma's HPAPI conjugates facility is SafeBridge certified
SAFC Pharma a division of SAFC and part of the Sigma-Aldrich Group has received Safebridge Consultants" certification at its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, for the safe handling of potent drug substances. The suite, located on the company's St Louis, Missouri site in the US, supports the entire drug development pipeline, from early-stage clinical supplies to kilogram quantities and expandable to commercial scale.
SAFC Pharma a division of SAFC and part of the Sigma-Aldrich Group has received Safebridge Consultants" certification at its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, for the safe handling of potent drug substances. The suite, located on the company's St Louis, Missouri site in the US, supports the entire drug development pipeline, from early-stage clinical supplies to kilogram quantities and expandable to commercial scale.
The HPAPI suite, commissioned in September 2008, enables the conjugation of HPAPIs to a variety of antibody drug conjugates (ADCs).
"Gaining SafeBridge certification status for our HPAPI conjugation suite provides our customers with complete confidence in our ability to handle their potent compound projects safely and efficiently," said David Feldker, SAFC Pharma vice president. "The suite builds upon 15 years of HPAPI manufacturing experience at SAFC's Madison, Wisconsin site, which is also SafeBridge certified, and upon more than 30 years of experience in conjugation technology at the St Louis facility."
The SafeBridge assessment programme focuses on management, hazard identification and evaluation, hazard controls and communication, education and training.
