Stability Testing of Biological Products: 9 Challenges
List Apr 15, 2019
The efficacy and safety of a biopharmaceutical product depends on the product’s ability to maintain its molecular confirmation.
As there is no single assay or parameter that sufficiently profiles the stability characteristics of a biological product, protocols for assessing stability can vary greatly.
This list takes guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals, which is considered to have set the highest global standards for the quality, efficacy and safety of medicinal products.
Download this list to get an overview of the general considerations that should be on your stability-assessment checklist.
The host systems often used to manufacture protein-based biotherapeutics can produce their own endogenous proteins, known as host cell proteins (HCPs), which can ultimately contaminate the product. Download this list to learn about some of the most commonly used methods for HCP analysis.READ MORE