Search results for " formulation"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
These methods are among the most frequently used tests for lot release of drug substance and drug product,5 as well as during formulation and process development. Several multi-product analytical meth…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
Zaltrap is approved for treatment of colorectal cancer, and the active ingredient is also marketed in a different formulation as Eylea, approved in 2011 for the treatment of age-related macular degene…
Article
Quality by design for biotechnology products—part 1
They include but are not limited to product-related variants, process-related impurities, formulation parameters, and essential attributes such as appearance. Examples of process-related impurities in…