This report affords readers the opportunity to gain insight into the bioprocessing market and where it’s heading. It provides an overview of the current market dynamics for bioprocessing as well as an outlook on what our survey respondents predict the marketplace will look like in five years. You can purchase the full report or download a free preview by clicking here.
Retraining an operator involved in a microbiological excursion is almost always part of the corrective and preventative action (CAPA), yet repeat excursions and deviations due to improper aseptic technique still routinely occur. So, why do some operators still have difficulty executing the task after completing such intensive training programs?
The Purple Book Continuity Act of 2019 represents a laudable effort to build on the FDA’s initial work in establishing the Purple Book and supporting the development of biosimilars. However, efforts to address data standards for biosimilars or to include patent listings in the Purple Book are misplaced.
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By Evan Pasenello and Daniel Sayut,AbbVie
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.
Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trend are towards higher cell densities and protein titers.
Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR assay and, by doing so, shows how you can get results in less than half the time compared with ELISA.
This note addresses the performance of Pall’s mixed-mode cation exchange (CEX) CMM HyperCel sorbent, which can be applied to both monoclonal antibody (mAb) polishing and recombinant protein purification.