Featured Editorial

  1. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

    The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

  2. 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.

  3. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

    The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

  4. 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    Confused about FDA's draft guidance on potency assays for cell and gene therapy products?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.

  5. 3 Focus Areas To Transition From Clinical To Commercial Readiness 11/12/2024

    Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.

  6. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

  7. Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning 10/24/2024

    BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.

  8. Exploring Sanofi R&D's Batch Monitoring Initiative 10/23/2024

    The project established predictability during testing and release for the production of medicine to support clinical trials.

  9. FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission 10/18/2024

    The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

  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.