CLINICAL SUPPLY MANUFACTURING RESOURCES

• Speed To Market – API Large-Scale Commercial Manufacturing

  Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

• GxP Inventory Solution Improves Clinical IP Efficiency And Compliance

  Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.

• Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing

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

• Inside A Gene Therapy Facility, Commercialization & Industrialization Project

  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. 

• 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.

• Safeguarding Cell Therapy Cryopreservation: Primary Containers

  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.

• Developing Injectable Drug Placebo Formulations For Clinical Trials

  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.