Biosimilar Regulatory solution center

1. The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality 2/13/2026

   The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

2. If Sustainability Is A Priority, Why Is Progress So Slow? 2/10/2026

   Sustainability is now central to biopharma strategy. New data reveals why commitments aren’t translating into action, and the roadblocks leaders must address to turn environmental ambition into change.

3. Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers 2/4/2026

   Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.

4. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

   International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

5. Facility Considerations When Retrofitting Legacy Sites For ADCs 1/26/2026

   Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

6. Building Enterprise Resilience From QRM Signals 1/16/2026

   Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

7. New Year, New Biopharma: Game Changers We're Betting On 1/15/2026

   Digital innovation and regulatory evolution are reshaping biopharma. From AI to breakthroughs in oncology and gene editing, discover the trends and challenges that could define the industry.

8. Sterile Injectables: Why Innovation Matters More Than Ever 1/15/2026

   New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.

9. Three Tips To Put Your Viral Vector On The Path To Regulatory Success 1/15/2026

   Gene therapy regulations are evolving fast, creating uncertainty for developers. Discover three strategies to navigate approval challenges and keep pace with changing expectations.

10. A Sustainable Future: Phasing Out Animal Testing 1/14/2026

    Discover a practical roadmap for replacing animal tests with advanced molecular methods, as well as how regulatory updates and innovative technologies are shaping a sustainable future.