Allows users to increase the galactose site occupancy on the oligosaccharide to a higher level
US contract manufacturer Sigma-Aldrich has introduced a protein quality supplement called EX-CELL Glycosylation Adjust (Gal+) for biological drug production, including biosimiliars.
EX-CELL Gal+ is said to allow users easily to achieve desired N-linked glycosylation by increasing the galactose site occupancy on the oligosaccharide to a higher level. The ready-to-use, GMP protein quality supplement is proven to work with a range of cell lines, including SAFC’s proprietary CHOZN cell line platform.
SAFC says biosimiliar manufacturers will benefit from this product as regulators demand that their drug matches the originator protein reference profile, including the glycoprofile. Convenient titration of EX-CELL Gal+ into the bioreactor allows users to directionally adjust their product to match the specific reference profile. Likewise, companies with originator molecules can use the new supplement as a method to control or change N-linked glycosylation.
'This supplement was designed to decrease our customers’ process development timelines. Particularly in the case of biosimilar companies time is of the essence and the race to be first to market is paramount,' said Deborah Stutz, Director, Biopharma Marketing. 'If they cannot match the drug reference profile they are unlikely to be successful.'