FDA Announces Plan to Phase Out Animal Testing Requirement for mAbs and Other Drugs

📅 April 10, 2025

What the FDA announced:

  • Plan to phase out animal testing requirements for monoclonal antibodies and other drugs​
  • Reinforcement of the 3R principles: Replace, Reduce, Refine animal use​
  • Encouragement of alternative methods to animal testing to accelerate drug development & decrease costs​

At PathoQuest, with our animal-free GMP NGS platform for cell bank testing and vaccine, oncolytic virus, cell/gene therapy lot release testing, we enable biopharma companies to:​

  • Replace animal use in viral safety workflows​
  • Speed up QC timelines and overall development​
  • Prepare for regulatory expectations

 

📎 Read the FDA Announcement: CLICK HERE

👉 See our Vaccine journal publication on in vivo replacement with NGS: CLICK HERE

 Want to explore how NGS can replace in vivo testing in your viral safety strategy?