Clinical Supply Manufacturing Articles

  1. 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    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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.

  2. 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.

  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. Does Single-use Seem Daunting? Try Starting With Standard Assemblies 7/8/2024

    You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

  5. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

  6. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield 8/27/2024

    This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

  7. Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship 3/25/2022

    Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.

  8. 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.

  9. New Guide Tackles Best Practices For Making Allogeneic Cell Therapies 6/3/2024

    The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

  10. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

    Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.