Newsletter | September 11, 2021

09.11.21 -- Optimizing Processes Along The Manufacturing Journey

Transitioning From Vial To Prefilled Syringe: How Formulation Development Affects Manufacturing

Understanding how formulation development for a prefilled syringe affects manufacturing can drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Rapid Global Characterization Of Immunoglobulin G1 Following Oxidative Stress

Learn a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) GI monoclonal antibodies (mAbs).

Strategies To Achieve Successful Approval And Launch

Four experts share how scale-up, regulatory expectations, demand forecasting, and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

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

For this study, an IgG1 antibody was cleaved into antigen-binding fragments using pepsin and papain digestion respectively, followed by Protein A purification.