Clinical Supply Regulatory Articles

  1. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

  2. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  3. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

  4. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

    Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

  5. New Group Wants 'Phase-Appropriate' Thinking To Retire 9/4/2025

    Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

  6. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

  7. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

    At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

  8. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

  9. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

    The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

  10. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.