Outsourced Pharma App Notes & Case Studies

1. Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission 6/26/2024

   The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.

2. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

   To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

3. Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing 10/29/2024

   Explore study results evaluating the physical compatibility of single-use components in the Mobius® ADC Reactor and the level of extractables when exposed to dimethyl sulfoxide and dimethyl acetamide.

4. How To Get Products To Patients Faster With A Connected QMS 8/14/2025

   BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

5. Benchmarking Filtration Performance Of TFF Cassettes 5/30/2025

   Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

6. Seed Train Intensification Using High Cell Density Cryopreservation 8/11/2025

   Streamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.

7. Set Up And Qualify GMP Laboratories 7/10/2025

   See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

8. Gene Therapy In-Use And Device Compatibility Studies 7/28/2025

   Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.

9. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

   Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

10. Vial Adapter Transfer Device Compatibility With Cell Therapies 7/25/2025

    Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.