The biological activity of biopharmaceutical compounds (such as peptides, monoclonal antibodies, growth factors, and cytokines) has a direct bearing on their potency, which is a critical quality
attribute and a representation of efficacy. For biopharma companies,
measuring a cell’s bioactivity is important when:
• Screening compounds to develop the lead candidate;
• Validating potency when applying for regulatory approval;
• Confirming that the biological characteristics of the productremain consistent throughout the development cycle andfrom lot-to-lot, or site-to-site;
• Controlling for a compound’s quality prior to productrelease (either for a clinical trial or commercialization);
• Testing for stability; and
• Demonstrating biosimilarity between a biosimilar and theoriginator compound.
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Growing experience confirms the value of in vitro release test (IVRT) in the measurement of drug release properties in topical semisolid dosage forms. IVRT is increasingly used to profile drug performance characteristics in the development of both innovator and generic
Stability testing is, in essence, a quality control process and is therefore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as an ongoing program rather than as a periodic exercise.