Clinical Supply Manufacturing Articles

1. 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.

2. 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.

3. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

   AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

4. Green Gains In Biopharma Without Closing Facilities? 2/29/2024

   Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.

5. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

   This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

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. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

8. Scaling RNA Production From The Lab To The Clinic 8/9/2024

   Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

9. 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.

10. 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.