The latest issue of BioProcess International focuses on downstream processing, including flexible chromatography media and tentacle ion exchangers. It also includes articles focused on the regulatory landscape for biosimilars and freeze-thaw validation.
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Cell Therapies Supplement
As cell/gene therapies progress toward large-scale viability, demonstrating process control and managing risk come to the forefront, and developers are logically borrowing approaches already established in the larger biopharmaceutical industry. This focused supplement highlights how quality by design (QbD) can help companies achieve cost efficiencies with process analytical technologies (PATs) and smart scale-up planning.
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Manufacturers strive toward cost-effective purification of target molecules and a high level of confidence that their biologics are safe and not compromised by the presence of endogenous retrovirus-like particles or adventitious viruses (1). Reliable reduction of viral particles throughout downstream purification processes must be ensured through different techniques such as chemical treatment, filtration, and chromatography. Common monoclonal antibody (MAb) purification schemes use both cation- and anion-exchange chromatography steps (CEX, AEX). Although CEX (to remove product- and process-related impurities) is not…