Comparability & Lot Release Testing
Lot Release and Comparability testing is necessary for evaluating the purity, potency, and identity of biologics. Analytical assays are available for quality control testing that is regulatory compliant.
Product release testing is a crucial part of ensuring drug product quality and safety. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require lot release tests for each biopharmaceutical batch. This testing is performed at all stages of drug development:
- Raw Materials
- Unprocessed Bulk
- Purified Bulk (Drug Substance)
- Final Product (Drug Product)
Lot Release Testing relies on previously established specifications to demonstrate product identity, purity, and potency. Similarly, Comparability testing is aimed at identifying whether changes in the manufacturing process lead to downstream changes in product quality.
Our Analytical Services offers a multitude of analytical methods to test your recombinant protein or monoclonal antibody. Our analytical assays can be performed to GMP guidelines to guarantee that regulatory specifications are met.
We offer the following methods for quality control of your product:
- Mass Spectrometry
- Capillary Electrophoresis
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