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Sigma-Aldrich Corporation. (10/29/14). "Press Release: SAFC Launches New Protein Quality Supplement to Increase N-linked Glycosylation". St. Louis.

Organisations Organisation SAFC Pharma
  Group Merck (DE) (Group)
  Organisation 2 Sigma-Aldrich Corporation (Nasdaq: SIAL)
  Group Merck (DE) (Group)
Products Product reagents (bio/biochemical)
  Product 2 biopharmaceutical
Person Person Stutz, Deborah (Sigma-Aldrich 201410 Director Biopharma Marketing)
     


Sigma-Aldrich® Corp. (NASDAQ: SIAL) 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."

EX-CELL Glycosylation Adjust (Gal+) is commercially available as a catalog product. To learn more, or to make a purchase inquiry, please visit: www.sigma-aldrich.com/finishfaster.


About SAFC:

SAFC Commercial, the custom manufacturing and services business unit of Sigma-Aldrich Corporation, is recognized as a top 10 global specialty chemicals and biologics supplier. As a trusted manufacturer for the life science and high-technology industries, SAFC works closely with customers to resolve development challenges and accelerate the product pipeline using its global "Centers of Excellence" and dedicated manufacturing facilities. Its rich portfolio includes high-purity inorganic materials for high-technology applications, critical raw materials and extensive biologics safety testing services for biopharmaceutical manufacturing, and complex, high-potent APIs and key intermediates for pharmaceutical manufacturing. For more information, visit www.sigma-aldrich.com/safc.


About Sigma-Aldrich:

Sigma-Aldrich, a leading life science and high-technology company focused on enhancing human health and safety, manufactures and distributes 230,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets. With three distinct business units - Research, Applied and SAFC Commercial - Sigma-Aldrich is committed to enabling science to improve the quality of life. The company operates in 37 countries, has more than 9,000 employees worldwide and had sales of $2.7 billion in 2013. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.

Sigma-Aldrich is a registered trademark of Sigma-Aldrich Co. LLC.

©2014 Sigma-Aldrich Co. LLC. All rights reserved. Sigma-Aldrich, SAFC, CHOZN and EX-CELL are trademarks of Sigma-Aldrich Co. LLC or its affiliates, registered in the U.S. and other countries.

   
Record changed: 2017-04-02

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