Clinical Supply Manufacturing Articles

1. 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.

2. Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy 9/18/2023

   If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

3. 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.

4. 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.

5. 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.

6. 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.

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. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

   Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

9. Designing Highly Agile Bio/Pharma Manufacturing Facilities 4/5/2024

   In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

10. 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.