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. Controlled Substances In Clinical Trials 3/30/2023

    Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.

  3. Why Advanced cGMP Manufacturing Is Key to Pharma Success 1/26/2026

    Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.

  4. 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.

  5. Expertise And Transparency Drive A Distinct Development Journey 1/26/2026

    Coordinated expertise, real‑time visibility, and clear communication support smoother development, manufacturing, and clinical supply. Strong alignment improves predictability and lowers risk.

  6. Breaking Down Early Small Molecule Development 3/11/2026

    Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.

  7. Prepping For Commercialization Through Supply Chain Logistics

    While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.

  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. Advantages Of Robotic Aseptic Processing 10/6/2023

    Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.

  10. Building A Global Cell And Gene Supply Chain Serving Personalized Medicine 3/28/2022

    Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.