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The BioProcess International September Issue - Now Available in Print, Digital and Mobile App Editions
Date:9/30/2013

pharmaceutical development. She identifies a number of examples of its use in previous BPI articles and points to some meetingplaces for learning and sharing more about it.

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 Bio-Rad and a Chinese research institute present enhancements to the standard two-dimensional electrophoresis and Western blotting workflow. They apply these enhancements as a model example to evaluate a commercially available anti-HCP antibody reagent.

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.

Comparability Step by Step

With upstream chemistry analysis (UCA), the chemistry profile of cells screened in a process development environment can be identified early on using very small (microliter-scale) samples. In this article, Daniel Allen describes UCA technology adapted from hospital diagnostic laboratories using instruments already in most pharmaceutical laboratories. This could offer new parameters with which to select promising candidate cell lines.

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