Outsourced Pharma App Notes & Case Studies

1. 3 Steps To Optimize The Fed-Batch Process For mAb Production 6/2/2021

   We describe a straightforward way to achieve high-performing fed-batch process for a knockout cell line. This workflow improved titers 500% compared with CHO cell culture in basal medium.

2. Biotech Enables Accelerated Scale-Up Of A Spray-Drying Program 3/4/2022

   A virtual biotech, focused on the development and commercialization of a product to treat advanced solid tumors, partnered for the development, clinical trial supply, and scale-up of a spray-drying program.

3. Process Development For AAV Vector Production In Suspension Cells 11/19/2021

   Review experiments for the adaptation of the HEK293 suspension cell line for transient transfection and scalable adeno-associated virus (AAV) production.

4. Application Of A Sf-Rhabdovirus-Negative Platform For AAV Production 3/10/2023

   Discover a two-part system comprising a proven Sf-9 cell line devoid of Sf-rhabdovirus and a chemically defined medium engineered for it. Explore performances of this medium for AAV2 production.

5. What’s Happening In Cell & Gene Therapy Development? 2/8/2022

   This ISR report provides support and direction for innovator companies looking to outsource aspects of their cell and gene therapy manufacturing and development through shared research highlights.

6. Reduce Supply Chain Disruptions With Second Sourcing 3/16/2023

   Follow one CDMO's collaboration with Thermo Fisher Scientific to combat supply chain risks after one of the high-volume raw materials critical to their manufacturing process experienced a global shortage.

7. Biologics Outsourcing Differences By Company Size 6/14/2022

   ISR split the data from its most recent Biologic API CDMO Benchmarking report by large and non-large respondents to highlight the differences in outsourcing preferences and practices.

8. Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products 3/11/2022

   Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

9. 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.

10. Industry 4.0 Paving The Way For More Efficient Processes 9/9/2021

    From sensors and software to data-based services throughout production, Industry 4.0 solutions are opening new potential in terms of transparency, quality, safety and efficiency.