Austin, TX August 2012 – Using SACHEM’s Expell ™ SP1 displacer, scientists can achieve the isolation and enrichment of highly pure (>90%) charge variants from a monoclonal antibody sample in a single displacement chromatography run
Austin, TX August 9, 2012 Current Protocols in Protein Sciences published a new article on the Isolation of Monoclonal Antibody Charge Variants by Displacement Chromatography. Authors Dr. C. Patrick McAtee and Jacob Hornbuckle discuss the important parameters in designing and optimizing a separation of monoclonal antibody (mAb) charge variants from process streams by ion-exchange displacement chromatography. The protocol also review sample preparation and selection of matrix, column, and appropriate buffer.
Monoclonal antibody (mAb)-directed therapeutics represent the vast majority of new drug development programs in the pharmaceutical and biotechnology industry today. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have recently published new guidelines calling for enhanced scrutiny of mAbs, particularly with regard to analytical data, which could affect product pharmacokinetics (PK) and immunogenicity. This guidance has become most relevant in the realm of biosimilars or “biobetters.
“As manufacturing guidelines become increasingly more rigorous with a focus on detailed analytical parameters, this technology offers a new and insightful methodology for evaluation of factors contributing to the safety and efficacy of biotherapeutics. This represents a novel approach for analysis and production of biological therapeutics as it offers the ability to enhance purity to levels previously unattainable, which can affect PK profile and performance. A biosimilar so purified becomes a “biobetter. commented Dr. Patrick C. McAtee, Sr. Manager of Biotechnology Applications at SACHEM.
Headquartered in Austin, Texas, SACHEM is a chemical science company with full commercial operations and research facilities in North America, Europe, China and Japan. Our technology revolves around high purity and is successfully applied in markets like electronic materials, oilfield chemicals, catalysts, polymers, pharmaceutical, agrochemicals, biotechnology and energy materials.