Clinical Supply Manufacturing Articles

1. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

   Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

2. Solving The Leukopak Supply Chain Issue With Cryopreservation 11/25/2024

   Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.

3. Key Considerations For Early-Stage CGT Companies When Selecting A CDMO 12/16/2024

   For preclinical or early-stage cell or gene therapy companies, proper evaluation of each CDMO candidate should include the raw materials program, QC testing, and more.

4. 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.

5. 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.

6. 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.

7. 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. 

8. 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.

9. Luxturna Maker Spark Therapeutics' Flexible Platform Approach 8/28/2024

   The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.

10. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

    Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.