Focus on Regenerative Medicine
The components used to make a cell- and tissue-based product can vary greatly in source, complexity, and manufacturing. Ancillary materials can have a profound effect on the expansion, differentiation, or activity of a cell or tissue product and thus significantly affect its quality attributes. Ensuring the quality of a cell- or tissue-based therapeutic requires rigorous evaluation of the components used in its manufacture. As the authors report in this article, USP test specifications and physical reference standards can help.
Special Report: Protein A
Because of the inherent and engineered variations in therapeutic antibody structures, there is no “one-size-fits-all” when it comes to techniques for MAb purification. The closest anything has come to this is evidenced by the success of protein A affinity chromatography, which has become the workhorse for antibody production. But it is not the perfect solution. Some experts refer to new alternatives as “disruptive,” while predicting that protein A will continue to be used for commercial-scale MAb purification throughout the foreseeable future. In this article,
Well known for its utility in raw-materials testing, spectroscopy has extended itself throughout bioprocess development in various forms (e.g., NMR , Raman, and FTIR). In this article, senior technical editor
Evaluating Anti-HCP Activity
Biologics require accurate monitoring and effective removal of process-derived impurities. Among those, host-cell proteins (HCPs) may be the most challenging because an expression system’s proteome involves thousands of different proteins, some of which can copurify with the drug. Multianalyte assays need to detect most protein impurities that could be present. In this article, authors from
Process Monitoring and Control
Commercial inline sensor systems can monitor process parameters such as pH or dissolved oxygen concentration in real time. For other parameters — e.g., glucose concentration, total cell count, and viability — no robust online prediction is yet possible for many applications. The gap could be closed using NIR spectroscopy, which provides quantitative prediction of single analytes in real time. In this article, academic and supplier authors describe evaluation of a new free-beam NIR spectrometer for monitoring and control of a mammalian cell cultivation processes.
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