Ethics in the Lab
FDA’s 2025 Plan to Phase Out Some Animal Testing — What It Means for Your Lab and how BRAND Cell Culture Inserts are a fit.
On April 10, 2025, the FDA announced plans to phase out certain animal testing requirements, starting with monoclonal antibodies (mAbs) and eventually expanding to other drug categories. The agency is encouraging immediate use of New Approach Methodologies (NAMs)—such as advanced in vitro models and computational tools—in Investigational New Drug (IND) submissions, supported by a new roadmap outlining the transition (read the FDA announcement here).
The first step is a pilot program for select mAb developers, allowing safety packages to be built mainly on non-animal methods. Lessons from the pilot will guide updated policies. Public workshops are already underway to gather input from industry, academia, and government. While not yet a full ban, the change signals growing pressure to use validated NAMs, with case-by-case waivers available during the transition.
For sponsors and labs, the direction is clear: human-relevant models should be used early to address toxicity, immunogenicity, and barrier or transport questions. Each method should have a clear context of use, and strong documentation—covering reproducibility, controls, variability, and acceptance criteria—will be key to regulatory acceptance. If you work with mAbs, now is the time to develop an integrated NAMs plan and engage with the FDA early.
BRAND cell culture inserts provide a reliable, versatile platform for NAMs-friendly assays—such as barrier models, air-liquid interface (ALI) cultures, immune cell migration, and co-cultures—that can replace many traditional animal-based tests. The BRAND 2in1 design works in both hanging and standing positions in standard well plates, making it easy to switch workflows without extra hardware. PET or PC membranes with cellGrade™ plus treatment support strong cell growth, while pore sizes from 0.4 to 8.0 micrometers suit a wide range of applications. Manufactured under ISO-class conditions with sterile options, they help labs meet regulatory expectations for validated in vitro methods while streamlining SOPs and audits.
As the FDA’s plan moves forward, labs that adopt proven in vitro systems now will be better positioned to meet new regulatory expectations and reduce reliance on animal testing. BRAND cell culture inserts are one of those proven tools—ready to help you build robust, scalable NAMs workflows from day one.
Sources:
U.S. Food and Drug Administration. April 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
U.S. Food and Drug Administration. July 30, 2025. https://www.fda.gov/about-fda/regulatory-news-stories-and-features/broad-appeal-fdas-workshop-reducing-animal-testing-hears-experts-more-humane-and-human-relevant
Reuters. April 2025. https://www.reuters.com/world/us/us-fda-phase-out-animal-testing-drug-development-2025-04-10/
