Merck Millipore, the Life Science business of Merck, has partnered with celares GmbH to provide pegylation services tocustomers developing protein-based therapeutics and biosimilars. The new service offering under the collaboration includes feasibility studies, process and analyticaldevelopment, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.

Pegylation, the attachment of polyethylene glycol to a molecule, is a delivery system for biologics that can enhance protein stability, bioavailability and solubility. The new services will leverage EMD Millipore’s range of functionalized PEG products of different molecular weight and activation chemistry, as well as buffers,solvents and excipients, unit operations employed during the pegylation process and subsequent purification including tangential and normal flow filtration andchromatography.

“Whilst a widely used approach to improving drug delivery, a successful of pegylation strategy is dependent upon materials expertise and application experience,” said Andrew Bulpin, executive vice president of Process Solutions, Merck Millipore. “celares is a recognized leader in this area and through our collaboration, weare now able to expand our service offering to include conjugation, further helping our biopharmaceutical and biosimiliar customers to optimize their protein therapeutics and to reduce their time to market.”

“An optimized formulation can help a promising protein therapeutic reach the clinic and patients in need,” said Dr. Frank Leenders, managing director of operations at celares GmbH. “Our expertise in pegylation combined with the experience and integrated products and unit operations from EMD Millipore will create customized solutions needed by the biopharmaceutical industry to maintain forward progress of promising drug candidates.”