Our Expert Network

1. Designing Our Way Toward Circular RNA Medicines With AI 5/21/2025

   The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.

2. A Road Map For PAT Monitoring And Control 5/8/2025

   Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

3. EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines 5/6/2025

   The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.

4. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

   Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.

5. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

6. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

7. Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture 4/15/2025

   No matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.

8. How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do 4/10/2025

   Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.

9. What Happens If The National Cancer Institute Loses Funding? 4/3/2025

   The National Cancer Institute is operating under a continuing resolution that maintains funding at the FY 2024 level of $7.22 billion. But when adjusted for inflation, it effectively reduces the real value of research dollars. So what are the consequences?

10. MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs 3/11/2025

    The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.