Biosimilar App Notes & Case Studies

1. Alkaline Stability Of Fc And VH3 Binding In Protein A Resins 5/1/2023

   In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).

2. Automating And Optimizing The Cell Harvesting Process 7/25/2022

   Discover how we automate the process of optimizing cell harvesting and further minimize the potential for cell loss during wash steps.

3. Alkaline Stability Of Modern Protein A Chromatography Resins 7/12/2023

   Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.

4. Outsourcing Process Dev: Key Considerations For Biopharma 3/14/2022

   In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

5. Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market 11/8/2021

   Understand the role training devices and patient education play with regard to self-injection therapies. Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

6. Generating A Robust Host Cell Line For A Cell Line Development Platform 11/14/2022

   Learn how cell performance within the context of the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.

7. In-House Manufacturing: Key To Driving A Diabetes Vaccine? 1/28/2022

   Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.

8. AAV Full/Empty Capsid Separation Using Mechanistic Modeling 5/1/2023

   In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl₂ is used as an elution additive.

9. AVROBIO’s Geoff MacKay On Cell & Gene Scalability 10/4/2021

   Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

10. Recombinant Adeno-Associated Virus Type 5 Production Process 10/12/2022

    Learn about a scalable process for the production of rAAV using triple plasmid transfection of suspension cells in an animal-derived component-free medium.