Featured Editorial

1. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

   This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

2. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

   The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

3. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

   Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

4. Why Do So Few Cell Therapies Make The Leap From Lab To GMP? 11/5/2025

   Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.

5. 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.

6. Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development 10/21/2025

   Discover how partnerships — especially with capable CROs — as well as resilient supply chains, digital enablement, regulatory foresight, and specialized talent impact the success of targeted protein degradation therapies.

7. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

   Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

8. What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish 9/11/2025

   Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.

9. New Group Wants 'Phase-Appropriate' Thinking To Retire 9/4/2025

   Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

10. 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.