Newsletter | August 12, 2022

08.12.22 -- Embarking On The Commercial Manufacturing Journey For A Biologic

 
Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies
 

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic drug product tech transfer.

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 mAb, Associated Antigen-Binding Fragments
 

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

Keys To A Successful Rapid Commercial Launch
 

Combining a rapid launch following regulatory approval with effective messaging and post-launch services is the key to making your launch successful and gaining a competitive advantage.