Improving Biopharmaceutical Safety through Verification-Based Quality Control

Improving Biopharmaceutical Safety through Verification-Based Quality Control Biopharmaceuticals and small-molecule drugs have different approval pathways but the same quality control (QC) paradigm, where the quality of released but untested units is inferred from that of tested but destroyed units. This inference-based QC will likely miss rare prerelease defects, and defects emerging after product release. The likelihood for such defects is heightened for biopharmaceuticals due to their complexity, which makes manufacturing errors more likely, and fragility, which makes postrelease damage more likely. To improve biopharmaceutical safety, we suggest transitioning their QC from inference- to verification-based practice by developing inspection technologies that can nondestructively verify the quality of every vial from the point of release to the point of care. One candidate, water proton NMR (wNMR), is briefly discussed. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Trends in Biotechnology Elsevier

Improving Biopharmaceutical Safety through Verification-Based Quality Control

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Publisher
Elsevier
Copyright
Copyright © 2017 Elsevier Ltd
ISSN
0167-7799
D.O.I.
10.1016/j.tibtech.2017.08.010
Publisher site
See Article on Publisher Site

Abstract

Biopharmaceuticals and small-molecule drugs have different approval pathways but the same quality control (QC) paradigm, where the quality of released but untested units is inferred from that of tested but destroyed units. This inference-based QC will likely miss rare prerelease defects, and defects emerging after product release. The likelihood for such defects is heightened for biopharmaceuticals due to their complexity, which makes manufacturing errors more likely, and fragility, which makes postrelease damage more likely. To improve biopharmaceutical safety, we suggest transitioning their QC from inference- to verification-based practice by developing inspection technologies that can nondestructively verify the quality of every vial from the point of release to the point of care. One candidate, water proton NMR (wNMR), is briefly discussed.

Journal

Trends in BiotechnologyElsevier

Published: Dec 1, 2017

References

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