Biosimilar Regulatory solution center

1. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

   The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

2. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

   Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

3. Streamline Process Development, Digitize Data, And Maximize Your Investments 10/20/2025

   Discover how AI, digital twins, and automation are transforming biomanufacturing by cutting costs, improving quality, and accelerating timelines for smarter, more efficient production.

4. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

   Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

5. 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.

6. Import Product Specifications And Drug Registration Testing For China 10/6/2025

   This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

7. What You Should Know About USP's Bioassay Updates 10/2/2025

   The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

8. Automation In The Lab: Lessons From Successes And Setbacks 9/24/2025

   Real-world examples show that, in some labs, manual screenings disappeared altogether, replaced by automated runs that now cover entire departments.

9. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

   Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

10. Take Action On PFAS To Protect Your Critical Processes 9/18/2025

    PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.