Clinical Supply Manufacturing Articles

  1. Defining When To Implement Technologies To Support Commercial Growth 11/20/2024

    Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

  2. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

  3. When In The Product's Life Cycle Does Continuous Manufacturing Make Sense? 2/1/2024

    This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

  4. Bridging Preclinical Science And Trial Supply Success 3/27/2026

    Bridging preclinical science and clinical supply ensures therapies reach patients efficiently. Early planning, collaboration, and flexible supply chains prevent costly delays.

  5. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

    The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

  6. When Should You Select Your Supply Partner? 9/19/2024

    In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

  7. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

  8. Scaling RNA Production From The Lab To The Clinic 8/9/2024

    Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

  9. Considerations For Potency Assurance Of CGT Products 11/12/2024

    Confused about FDA's draft guidance on potency assays for cell and gene therapy products? Let's clarify a few things and discuss some key considerations.

  10. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

    Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.