It allowed them to screen efficacy, stability, pharmacokinetics, and various aspects of manufacturability for hundreds of clones, then objectively select the best qualified clinical candidates, far in advance of commercial product development. Beyond giving the industry a foundation manufacturing method, it made IgG purification accessible to immunologists without the need for advanced purification skills. The ability of protein A affinity chromatography to achieve 95% purity in one simple step was the runway that got recombinant immunotherapy off the ground and made it available to millions. Therapeutic monoclonal IgG is an example. This is especially true for extended families of products that share highly similar chemical composition. Figure 1: Analytical size-exclusion chromatography (SEC) of bovine serum albumin (BSA) marketed for processing nucleic acids sample prestained with PicoGreen dye TSKgel G4000SWxl, 7.8 mm × 30 cm, 50 mM MES, 150 mM NaCl, 0.05% Pluronic reagent F68, pH 6.5 flow rate: 0.5 mL/min.Ī high-performing capture method is a critical bedrock asset for developing industrial purification processes.
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