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Quality control and analytical techniques for biopharmaceuticals.
C Jane Robinson1, Christopher Jones
1Biotherapeutics Group, National Institute for Biological Standards & Control, UK. Jane.Robinson@nibsc.hpa.org.uk
Bioanalysis
|December 24, 2010
Summary
Ensuring biopharmaceutical quality requires complementary analytical tests and bioassays to measure potency. Bioassays are crucial for assessing biological activity, complementing physicochemical methods in quality control.
Area of Science:
- Biopharmaceutical quality control
- Analytical chemistry
- Biotechnology
Background:
- Biopharmaceuticals are complex products requiring rigorous quality control.
- Regulatory guidelines mandate specific quality attributes for product release.
- Physicochemical techniques define product identity, integrity, and purity but not biological activity.
Purpose of the Study:
- To highlight the necessity of bioassays in biopharmaceutical quality control.
- To explain the role of bioassays in determining product potency.
- To discuss the complementary nature of bioassays and physicochemical methods.
Main Methods:
- Review of regulatory guidelines for biopharmaceutical quality attributes.
- Discussion of physicochemical techniques and their limitations in assessing biological activity.
- Explanation of bioassay principles for measuring potency.
Main Results:
- Physicochemical methods alone are insufficient for assessing biopharmaceutical biological activity.
- Bioassays are essential for quantifying the specific biological effect of biopharmaceuticals.
- A combination of analytical tests and bioassays ensures batch-to-batch consistency and quality.
Conclusions:
- Bioassays are indispensable for determining the potency of biopharmaceuticals.
- Integrating bioassays with physicochemical methods provides a comprehensive quality control strategy.
- The selection of appropriate bioassay systems is critical for accurate potency determination.
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