Clinical Supply Manufacturing Recources

  1. 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).

  2. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

  3. Overcoming Challenges In Cell And Gene Therapy Containment

    Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

  4. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  5. 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.

  6. Practical Playbook For The Manual Assembly Of Combination Products 2/12/2026

    Manual assembly plays a vital role in early‑phase combination product development. Learn how strong process design, collaboration, and quality controls help teams reduce risk, improve consistency, and move confidently toward later‑stage manufacturing.

  7. Capsule Filling Science: Improving Efficiency and Accuracy 1/26/2026

    Modern trials rely on storage that protects temperature‑sensitive materials. GMP‑ready spaces, monitoring, and flexible capacity help teams manage risk, ensure quality, and keep studies moving.

  8. De-Risking Your Bioconjugate's Path To Clinical Manufacturing 9/30/2022

    Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

  9. 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.