Featured Editorial

1. 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.

2. A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries 8/30/2024

   To find suppliers and partners for our clinical trial programs, we need to go beyond just selecting the best offer and then managing them. For virtual organizations in particular, we must strive to be the partner of choice. 

3. 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.

4. The Small Biotech's Checklist For FIH Trials 8/27/2024

   Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

5. 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. 

6. 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.

7. Should You Be Using Unique Container Identification? 8/22/2024

   Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

8. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services 8/15/2024

   These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

9. 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.

10. Clinical Trial QA Strategies In Low- And Middle-Income Countries 8/9/2024

    This author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.