With >20 approved products and >160 in clinical trials, MAbs are just such a class of molecule ( 1). MAb Platform ToolboxĪ platform process includes a number of unit operations, methods, and conditions based on experience gained from purifying a class of molecules that have similar properties ( 6, 7, 8, 9, 10). The high purity that follows capture on protein A resins, combined with the multimodal functionality of Capto adhere resin, provides for highly productive, two-step processes ( 4, 5). With the recently introduced Capto adhere multimodal anion-exchange resin, which has high selectivity for contaminants that remain after protein A separation, an additional step has been taken toward developing highly effective MAb downstream processes ( 3). KEYWORDS: HCP, MULTIMODAL CHROMATOGRAPHY, PLATFORM TECHNOLOGIES, AGGREGATES WHO SHOULD READ: PROCESS DEVELOPMENT, MANUFACTURING Protein A thus forms the foundation for the success of most MAb platform approaches to downstream processing. In generic protocols with direct capture of MAb from clarified cell culture supernatant, the high selectivity of protein A resins provides a high yield of very pure product. Today, nearly all approved MAb processes include a capture step using protein A. Many MAb producers are now adopting such approaches. That demand, combined with its potential for reducing time-to-market, has increased interest in the value of platform approaches to MAb production (upstream as well as downstream). As a consequence, demand has increased for more efficient downstream processes. Today, it is possible to see titers of 4–5 g/L, and expression levels as high as 15 g/L and greater have been reported. An increasing demand for MAbs during the past decade has led to intense development of high-expression cell cultures ( 2).
Monoclonal antibodies (MAbs) constitute ∼30% of the biopharmaceutical products currently under development ( 1).
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