Clinical Supply Manufacturing Articles

1. Beware The Manufacturing Bottleneck: Lessons From Inside 6/6/2022

   Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.” 

2. 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.

3. 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.

4. 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.

5. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

   Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

6. The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond 12/2/2024

   These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

7. NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach 4/24/2024

   We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.

8. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

   The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

10. 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.