EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced a collaboration with celares GmbH to provide pegylation services to customers developing protein-based therapeutics and biosimilars. The new service offering enabled by the collaboration includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.
Pegylation, the attachment of polyethylene glycol to a molecule, can significantly improve the pharmacological and physicochemical properties of peptide and protein therapeutics and reduce side effects. This well-recognized delivery system for biologics can enhance protein stability, bioavailability and solubility, overcoming common challenges in the development of these therapeutics.
“Whilst a widely used approach to improving drug delivery, a successful pegylation strategy is dependent upon materials expertise and application experience,” said Andrew Bulpin, Executive Vice President of Process Solutions, EMD Millipore. “celares is a recognized leader in this area and through our collaboration, we are 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.”
The new services will leverage EMD Millipore’s broad 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 and chromatography.
“An optimized formulation can help a promising protein therapeutic reach the clinic and patients in need,” said Dr. Frank Leenders, Managing Director of Operations, 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.”