Biosimilar Regulatory solution center

1. Where Contamination Control Really Breaks Down In Practice 3/13/2026

   Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

2. Trends In FDA FY 2025 Warning Letters 3/13/2026

   The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

3. 5 QMS Blind Spots You Should Know About 3/6/2026

   Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

4. What To Know About — And How To Apply For — FDA's PreCheck Pilot 2/23/2026

   FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.

5. A Comprehensive Solution For Adventitious Agent Testing 2/13/2026

   Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

6. 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."

7. 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.

8. 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.

9. 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.

10. 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.