SAFC Launches New Protein Quality Supplement To Increase N-linked Glycosylation

Sigma-Aldrich® Corp.

today announced that SAFC® Commercial (www.safcglobal.com), its custom manufacturing services business unit, has introduced a new protein quality supplement called EX-CELL® Glycosylation Adjust (Gal+). Specifically designed as a supplement for biological drug production, including biosimiliars, EX-CELL Glycosylation Adjust (Gal+) allows users to easily 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 broad range of cell lines, including SAFC's proprietary CHOZN® cell line platform. Biosimiliar manufacturers can benefit from the use of this product as regulators demand their drug matches the originator protein reference profile, including the glycoprofile. Convenient titration of EX-CELL Glycosylation Adjust (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." Although many "trial and error" methods can be implemented to alter the glycoprofile of a protein, these can take months to optimize. EX-CELL Glycosylation Adjust (Gal+) is the first off-the-shelf protein quality supplement that can achieve functionally relevant shifts in N-linked glycosylation quickly and efficiently. The supplement is highly concentrated, therefore customers only need to add a small amount of product to their bioreactor. "We are delighted that successful beta testing of EX-CELL Glycosylation Adjust (Gal+) has been completed," Stutz added. "Customers are impressed with their results, particularly as supplementation has shown no adverse effect on either productivity or cell growth."