Catalent Biologics Content

1. Process Development: Ensuring A Consistent, High-Quality Biologic 11/4/2020

   Gain insights on risk mitigation, the differences between innovator and biosimilar drug product process development, and what to expect from a partner during the process development phase.

2. Rapid Global Characterization Of Immunoglobulin G1 Following Oxidative Stress 11/22/2019

   Review a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) G1 monoclonal antibodies (mAbs).

3. High-Throughput Preformulation Development Platform For Biologics 11/21/2019

   A high-throughput formulation development for sample preparation and sample analysis enabled a simple and less labor-intensive screening of a broad range of conditions in considerably less time.

4. Analytical Quality By Design Using Design Of Experiments 11/21/2019

   Design of Experiment (DoE) is the centerpiece of analytical Quality by Design. A DoE assay development pipeline approach delivers optimized, robust, and rugged analytical methods ready for method qualification.

5. Strategies To Achieve Successful Approval & Launch 11/18/2019

   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.

6. Standardizing Process Characterization And Late Phase Development 11/18/2019

   Learn an approach for process characterization to produce a monoclonal antibody, specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.

7. Characterization Of A Therapeutic mAb, Associated Antigen-Binding Fragments 10/9/2019

   Determining size homogeneity of a 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.

8. Intensified Fed-Batch Process Using N-1 Perfusion And ambr 15 10/9/2019

   Learn how to combine N-1 perfusion with the ambr®15 bioreactor system to create a powerful tool for rapid development of a highly efficient cell culture process.

9. A Strategy To Remove Formulation Development From The Critical Path During Biologics Development 6/10/2019

   As the product development program progresses to phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. This Q&A discusses the utilization of automation, specifically the Uncle platform, during formulation development.

10. Solution To Ensure Quantity And Quality Of The Excipient Polysorbate-80 In Drug Formulations 6/10/2019

    Excipients are valuable substances used to improve stability and potency, but sourcing and stability of the excipients themselves can be a challenge. A two-method solution to evaluate one such excipient, PS-80, for quantity and quality has multiple applications for drug developers looking to utilize this in their final product.