Clinical Supply Manufacturing Articles

1. Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity 4/19/2023

   Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.

2. 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.

3. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

   Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

4. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

   This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

5. 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.

6. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

   Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

7. Defining When To Implement Technologies To Support Commercial Growth 11/20/2024

   Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

8. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

9. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

   How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

10. 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.