Featured Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

  8. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders. 

  9. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

    This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

  10. 5 Strategic Advantages Of Manufacturing ADCs In-house 9/20/2024

    Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.