Newsletter | June 3, 2021

06.03.21 -- Standardize Process Characterization & Late Phase Development

Elemental Impurities Risk Assessment For Finished Drug Products

This webinar reviews the impact of recent regulatory changes related to elemental impurities testing, guidance on the best routes to compliance, and an overview of the elemental impurities risk assessment process.

Characterization Of A Therapeutic Monoclonal Antibody (mAb), Associated Antigen-Binding Fragments

Determining size homogeneity of a monoclonal antibody (mAb) in solution is important for comparability and characterization of these medications. For this study, an IgG1 antibody was cleaved into antigen-binding fragments using pepsin and papain digestion respectively, followed by Protein A purification.

Standardizing Process Characterization And Late-Phase Development

For therapies progressing toward commercial manufacturing, understanding the operational, regulatory, and quality connections is critical for successful filing and launch. Review an approach for process characterization to produce a monoclonal antibody (mAb), specifically at the drug substance biomanufacturing step, that will improve efficiency and effectiveness.