The latest issue of BioProcess International focuses on manufacturing, featuring articles on tissue bioprinting, lipid feed formulations, viral vector manufacturing for gene therapies, biosimilar MAbs, and conjugate characterization. Also includes a special report on Antibody-Drug Conjugates (ADCs).
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Single-use components and systems are now firmly established in the biopharmaceutical industry. They continue to improve, and their applications are expanding. It seems that for every scientific challenge users discover, suppliers can engineer a solution. New technologies could improve productivity as well as provide the expected single-use benefits. Discover here a disposable valve, a next-generation bioreactor, a continuous culture process, and downstream processing based on single-use technology.
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Last month, Part 1 of this discussion briefly described the regulatory landscape for developing biosimilar therapeutic monoclonal antibodies (TMAbs). We identified certain specific structural components of TMAb drug substances that warrant particular attention because alterations to them are likely to affect therapeutic safety and effectiveness. Now we conclude by considering whether studies of reference materials can further the development of analytical industry standards to ensure comparability of putative biosimilar TMAbs with innovator TMAbs. We suggest that the time is right…