New EX-CELL(R) CD Hydrolysate Fusion Media Supplement for Cell Culture Applications is the First Known Chemically Defined Hydrolysate Replacement Based on Raw Material Characterization
ST. LOUIS, July 29 /PRNewswire-FirstCall/ -- SAFC Biosciences(R), a business segment within SAFC(R), a member of the Sigma-Aldrich Group (Nasdaq: SIAL), announced today that it has developed a new, chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials. The introduction of EX-CELL(R) CD Hydrolysate Fusion marks the Company's continued focus on raw material characterization (http://www.safcbiosciences.com/ChemicallyDefinedComponents).
Scientists at SAFC Biosciences have determined that an ideal method for biopharmaceutical manufacturers to increase process consistency and reproducibility, while mimicking the productivity and quality profile results from their current hydrolysate-containing processes, is to fully characterize and define those components contained within them. As a result of these studies, EX-CELL CD Hydrolysate Fusion, a synthetically produced animal-component free, chemically defined alternative to undefined hydrolysates, has been created for use in CHO, NS0 and Sp2/0 biopharmaceutical production processes. The liquid version (Product No. 14700C) is formulated as a 20X concentrated supplement designed to have minimal pH and osmolality impact upon addition. For additional flexibility, a readily soluble dry powder version (Product No. 24700C) is also available.
EX-CELL CD Hydrolysate Fusion was developed utilizing Sigma-Aldrich's unique analytical capabilities and expert biological assay development knowledge. This partnership of technology and expertise enabled SAFC Biosciences to develop the first known chemically defined hydrolysate replacement. Matt Caple, SAFC Biosciences Director of Cell Sciences and Development, states: "The capacity for hydrolysates to exert substantial positive impact on cell growth and/or protein production is well documented. But, the undefined and variable nature of these components still inhibits the pursuit of highly controlled and defined pharmaceutical production processes. EX-CELL CD Hydrolysate Fusion resolves this challenge by delivering a fully defined raw material."
Bruce Lehr, SAFC Biosciences Director of Marketing, states: "Raw material understanding and characterization is a leading concern for biopharmaceutical manufacturers interested in mitigating risk.