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Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.
Sigma-Aldrich’s custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.
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. According to SAFC, the ready-to-use, GMP protein quality supplement can be used on a broad range of cell lines, including SAFC’s proprietary CHOZN cell line platform.
With regulators demanding that biosimilars match the originator protein reference profile, which includes the glycoprofile, manufacturers can now benefit from EX-CELL Glycosylation Adjust (Gal+). Convenient titration of the new supplement into the bioreactor allows users to directionally adjust their product to match the specific reference profile. Likewise, companies with originator molecules can use EX-CELL Glycosylation Adjust (Gal+) 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, in a press statement. “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.
EX-CELL Glycosylation Adjust (Gal+) is commercially available as a catalog product.