Genzyme to Expand Manufacturing Facilities
Genzyme (Cambridge, MA) is expanding its manufacturing and product-development operations in Belgium, Ireland, and the United Kingdom. The projects, totaling $500 million in capital investments, will help the company boost its antibody and protein-based medicines programs.
The new manufacturing plant in Geel, Belgium, will produce additional quantities of "Mozyme," an enzyme-replacement therapeutic currently under review by US and European regulatory authorities.
The Waterford, Ireland, site includes a biological fill-and-finish center to support increased sales of protein and antibody products manufactured at other Genzyme facilities. It will be the European fill–finish center for Genzyme's enzyme-replacement therapies for rare genetic diseases and for "Thymoglobulin" (antithymocyte globulin) for the treatment of acute rejection in patients with a kidney transplant.
Finally, Genzyme's Haverhill, UK, plant, which was significantly expanded in recent years to produce bulk sevelamer hydrochloride for "Renagel," is being further expanded to support clinical development of a wide range of potential new therapies, including sevelamer carbonate for chronic kidney disease and "Tolevamer" for Clostridium difficile–associated diarrhea.
"We are very pleased to have the opportunity to further deepen our presence in the European medical and biotechnology community, which has been an important part of Genzyme's growth since our earliest days," said Henri A. Termeer, chairman and CEO of Genzyme, in a release. "As our presence in Europe has grown, so has our ability to serve the needs of patients throughout the world, using a variety of approaches to address a broad range of serious diseases."
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.