Outsourced Pharma App Notes & Case Studies

1. Overcoming Inventory Challenges For A Complex, Global Study 7/14/2022

   A CRO customer and a clinical sponsor both lacked an unblinded supply management role to oversee Interactive Response Technologies (IRT) platform supply strategies and monitor inventory levels.

2. Next Generation Sequencing For Adventitious Agent Detection In Cell Banks 2/23/2023

   NGS-based methods for agnostic broad range detection are suitable options to augment or replace current virus testing methodology. Explore a NGS AAT method for cell line characterization and more.

3. bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches 10/4/2021

   bluebird bio's Scott Cleve sat down with The Business of Biotech podcast to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

4. 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).

5. Development Of A Novel Cell Culture Medium For AAV Production 9/26/2023

   Explore the medium development process of a novel cell culture medium for AAV production with multiple HEK293 lineages, which was performed with three different HEK293 cell lines to maximize AAV titers.

6. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

   Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

7. Selecting Drug Delivery Systems For Higher Doses, Higher Viscosities, And Lower Risk 1/18/2022

   Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

8. The Importance Of CDMO Capacity For Viral Vectors: A Conversation With Forge’s Dr. Timothy Miller 10/4/2021

   In this episode of The Business of Biotech, Forge Biologics' Dr. Timothy Miller talks about the importance of increasing specialized CDMO capacity for cell and gene therapy applications.

9. Biacore™ SPR Systems For Titer Analysis Of Adeno-Associated Virus 10/13/2022

   We describe the performance of two assays for titer analysis of adeno-associated virus (AAV), serotype 2 and serotype 5, based on surface plasmon resonance (SPR).

10. Applying High Throughput Processes To Optimize AAV Titers 3/8/2023

    A growing number of AAV product developers are recognizing the value in moving to suspension as early in development as possible in order to optimize production.