Clinical Supply Manufacturing Articles

  1. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

  2. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

  3. If The CDMO Shoe Fits, Wear It Now 9/16/2024

    Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

  4. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  5. Peeling Back The Layers Of Radiolabeled Peptide Production 6/12/2025

    From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

  6. 4 Tips For Advancing Your AAV Manufacturing Plans 1/4/2022

    Tim Kelly, M.B.A., COO of Homology Medicines, a clinical-stage genetic medicines company, shares four lessons his company learned from building a GMP facility and testing and optimizing their novel platform.

  7. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

    The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

  8. Challenges And Opportunities Of Outsourcing Biopharma Development 2/19/2025

    Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

  9. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

  10. The $122 Billion Question: Can Clinical Trial Supply Systems Keep Pace With Cell Therapy Demand? 5/14/2026

    Cell therapy demand is outpacing manufacturing capacity, forcing clinical supply teams to rethink patient scheduling, production slots, and real-time coordination.