EMD Millipore and celares team to offer PEGylation to biologic makers
EMD Millipore (the life science business of Merck KGaA) has teamed up with Berlin, Germany-based chemical modification company celares GmbH to offer both large and small customers PEGylation services to increase the bioavailability and pharmacological and physicochemical properties of peptide, proteins and biosimilar drugs.
The combination of celares’ technology and EMD’s activated PEG capability will help speed-up development and scale-up processes, and simplify projects by having one direct partner instead of two, therefore reducing time to market Roger Weibel - Head Bioavailability Enhancement – told this publication.
PEGylation involves the attachment of polyethylene glycol to a molecule to improve the pharmacological and physicochemical properties of drug candidates, and according to Weibel “celares is one of the very few providers of PEGylation services globally that has knowledge of attaching PEG-chains to biological molecules.”
“This is not an easy task,” he continued. “On one hand is the issue of specificity, e.g. attaching the right number of PEG-chains to the right site at the protein or peptide; on the other hand is obtaining good yields, keeping in mind the very gentle reaction conditions required in order to not interfere with protein integrity.”
The challenging nature of combining biological and chemical worlds “speaks largely to the need for this type of service,” he added, but getting this right can both enhance the bioavailabilty of large molecules, enlarge the plasma circulation time and can help to reduce the immunogenicity of biopharmaceuticals.
The full service offering comprises of feasibility study, process development, scale-up (gram quantities), development of analytical methods and technology transfer, to allow the transfer to a CMO for commercial production.
“The conjugation work will be carried out at the celares Berlin site, while necessary development and production of activated PEG is done at EMD Millipore’s Switzerland site.”
The two firms are currently finalizing the first project for a customer.
