Clinical Supply Manufacturing Recources

  1. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  2. Faster From Formulation To Fill/Finish 7/12/2022

    Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

  3. Safeguarding Cell Therapy Cryopreservation: Primary Containers 5/20/2024

    Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.

  4. Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization 2/20/2024

    While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

  5. Vertex On Building Risk Into Manufacturing Network Strategy 9/17/2026

    Supply disruptions are becoming harder to predict. Explore practical strategies for continuity planning, supplier risk management, and network design to build lasting resilience.

  6. GMP Clinical Storage Strategies for Today's Complex Trials 1/26/2026

    Temperature‑sensitive therapies need more than basic freezer space. Purpose‑built GMP storage protects product integrity, supports compliance, and adds flexibility as trial complexity grows.

  7. Inside A Gene Therapy Facility, Commercialization & Industrialization Project 3/10/2021

    An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. 

  8. Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing 7/21/2022

    Explore the unique capabilities at a Vancouver, Canada site for clinical-scale manufacture of lipid nanoparticles (LNPs).

  9. Solving Logistic Complexities In The Era Of Personalized Medicine 1/1/2022

    Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.

  10. How Specialized CDMOs Help Advance Programs From Concept To Clinic 6/15/2026

    Integrated drug development streamlines manufacturing, analytics, and supply to cut risk and speed timelines. Inhalation advances and flexible partnerships help therapies reach commercialization faster.