Search results for " potency" in Articles / App Notes
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Suppose a potency result of 100% label claim for a release test of a particular lot is measured. Further, suppose the analytical method used to obtain this result has been shown to conform to the ATP …
Article
Challenges in Analytical Method Development and Validation
A direct potency test method may not exist, and instead, several surrogate test methods may need to be used for potency. Obviously, whenever new test methods are to be used throughout product developm…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“Full focus on SISPQ (safety, identity, strength, purity, and potency) is common to all medicines. However, for genetic vaccines, this means developing a whole new battery of analytical methods, espec…
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Good Manufacturing Practices: Challenges with Compliance
These address much of the obvious concerns such as potency, safety, and containment. There is less guidance, however, on how to formulate and develop a more complex biological drug product as you reac…
Article
Gene Therapies Push Viral Vector Production
Improper handling leads to loss of viral potency.
• Raw materials. Raw materials, such as growth factors and cytokines, that are required for manufacturing of gene therapy products are neith…
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Critical Quality Attributes Challenge Biologics Development
Protein modifications (such as post-translational modifications) and degradation products may affect potency as well as secondary pathways such as altered clearance or induction of immunogenicity.
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Those may include antibody-dependent cellular toxicity (ADCC), complement-dependent cytotoxicity (CDC) assays, reporter assays, and potency assays. Technologies used typically include ELISA, electroch…
Article
Address the complexity of protein characterization
…ration measurement, target binding, and describe how you can use these assays for assessment of drug potency (EC50) and stability.
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Article
Reviewing the Importance of Biosimilarity and Interchangeability
He explains that, for comparability, the biosimilar needs to demonstrate similarity to the reference product in terms of structure, function, purity, and potency. Analytical methods should thus be cho…
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Moving Biosimilars Forward in a Hesitant Market
Thus, to show that a product is exactly similar, that it would have the same potency, the same kind of reaction in the body, any immunogenicity, or that it would have the same kind of impact that an i…