Outsourced Pharma White Papers

1. Seven Steps For Allogeneic Cell Therapy Success 11/2/2022

   To prepare allogeneic, or "donor-derived," CAR T cells for commercial scale, you must consider scale-up, aseptic processing, single-use systems, facility design, starting material, supply chain, and logistics.

2. Understanding Of Amorphous Solid Dispersions & Their Downstream Development 2/7/2022

   Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

3. Rational Design & Development Of Lipid- Filled Hard Capsules 1/26/2022

   With the increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based drug delivery systems have become an important tool for formulation development.

4. What Every Clinical Team Should Consider Before The Next Protocol 6/3/2022

   Even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience: clinical trial participants.

5. State-Of-The-Art Bispecific Antibody Development 10/11/2022

   The promise of bispecific antibodies (bsAbs) stems from their off-the-shelf nature and ability to bind to two or more different targets or epitopes, thereby performing multiple functions.

6. Validating The Efficacy Of A Compound With Spatial Imaging 2/13/2023

   Discover how efficient target and efficacy validation can translate into substantial savings and market advantages for sponsors as a result of shortened development and approval timelines.

7. Leveraging The Bolar Exemption To Accelerate Market Access 3/17/2023

   Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

8. Remote Access And Monitoring Of Bioprocess Unit Operations 5/26/2022

   Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.

9. Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval? 1/24/2022

   Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.

10. A Multifaceted Strategy For Viral Safety In AAV Processes 3/10/2022

    Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.