Genzyme Recalls Three Lots of Thymoglobulin
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.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
