Outsourced Pharma App Notes & Case Studies

1. Examining Column Reproducibility During Method Development In Clinical Labs 6/28/2022

   In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.

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. Achieving Large-Scale Ophthalmic Production 11/10/2021

   Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

4. Integrated Manufacturing: Chromatography Meets Predesigned DeltaV 3/9/2021

   Cytiva’s pre-defined automation solution, Figurate, is now available as a turnkey solution by combining our industry-leading ÄKTA process chromatography system with the reliability of the DeltaV DCS platform.

5. N-Linked Glycan Analysis For Complex Glycoproteins 12/20/2021

   An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high quality material but had a low yield and was not scalable.

6. Choosing The Right CDMO For HPAPI Development, Manufacturing & Packaging 9/2/2021

   Pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging, and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Experts discussed the key considerations and best practices when outsourcing HPAPI development, manufacturing and packaging to a CDMO.

7. Former FDA Chief Talks COVID-19 Vaccine Future At Process Progress 8/17/2021

   Thermo Fisher Scientific’s Process Progress event, held virtually on June 9, 2021, convened industry experts from across the biomanufacturing space to explore the unique challenges inherent in developing today’s cutting-edge therapeutics. The event’s keynote interview, featuring former FDA commissioner Dr. Scott Gottlieb, focused on the evolving opportunities within the biomanufacturing space, including the advancements in messenger RNA (mRNA) vaccines that facilitated global response to the COVID-19 pandemic.

8. Secondary Packaging Strategies For Commercial Launch Of A Biologic 8/17/2022

   A commercial packaging solution can be the first and enduring impression that a sponsor company makes on a patient, and its suitability can impact a biologic’s commercial success.

9. mAbs Biotech Recognizes Value In Expertise, Track Record 4/13/2022

   See how reputation for quality and experience with antibodies were driving forces in the CDMO selection for a CPI-006 antibody program.

10. Transition To Closed Processing Systems 10/12/2022

    Learn about our transition to closed processes for expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.