On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns.
On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns. One of the lots of Thymoglobulin failed a visual stability test. The other two lots were recalled based on a predicted stability failure prior to the labeled expiration date.
Genzyme previously had problems with Thymoglobulin in September 2007, when it received an FDA warning letter related to the company’s its Thymoglobulin bulk manufacturing operations in Lyon, France. Specific violations cited included accepting components and intermediates that exceeded bioburden and pathogenic microorganism limits.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.