May 2025 Newsletter
On April 10, 2025, the U.S. Food and Drug Administration (FDA) officially announced a plan to gradually phase out mandatory animal testing requirements in the development of monoclonal antibodies and other drugs, replacing them with alternative strategies known as New Approach Methodologies (NAMs). This policy shift marks a major step toward more humane, cost-effective, and human-relevant drug development practices. The TAIHOYA ATMS Dynamic Culture System is a cell mechanobiology platform that closely aligns with the FDA’s policy direction.
Key Highlights of the Latest FDA Policy
- Effective immediately: The FDA encourages sponsors to prioritize the submission of non-animal testing data in Investigational New Drug (IND) applications.
- Pilot programs launched: The FDA has initiated NAMs pilot programs, allowing selected developers to use drug development strategies primarily based on non-animal methods.
- Accelerated review pathways: Submissions supported by robust non-animal data may benefit from optimized review processes and potential priority review.
How Does ATMS Help You Enter the “Non-Animal Testing Era”?
| Function | Description |
|---|---|
| Simulation of in vivo mechanical stimuli | Provides cyclic stretching and compression to create a culture environment that closely mimics physiological conditions in human organs |
| Support for drug screening | Enables in vitro disease models for rapid evaluation of drug efficacy, serving as a critical alternative data source to animal testing |
| Stem cell and tissue engineering applications | Enhances cell differentiation, osteogenesis, neural regeneration, and other functional outcomes |
| Reduced R&D costs and animal use | Supports the 3Rs principles (Replacement, Reduction, and Refinement) while accelerating time to market |
Broad application areas include:
| Application Area | Description |
|---|---|
| Cardiovascular disease models | Simulates vascular stretching to promote endothelial cell regeneration |
| Bone tissue engineering | Accelerates osteoblast differentiation and bone formation under cyclic mechanical loading |
| Neural regeneration | Promotes stem cell proliferation and neural reconstruction when combined with stretch-assisted hydrogels |
| Drug delivery platforms | Enhances extracellular vesicle (EV) yield and drug-loading efficiency under mechanical stimulation |
Contact us today to learn how Taihoya ATMS can help you transition into the new era of non-animal testing. Partner with us at the forefront of innovation to advance a safer, more effective future for regenerative medicine and drug development.
相關產品
TAIHOYA
In 2009, Taihoya launched the “ATMS Dynamic Culture System,” named after Artemis—the Greek goddess of the hunt, known for her precision in archery. The name reflects the system's design philosophy: to breathe life into a mechanical structure, enabling highly accurate movement—just like Artemis's legendary aim.
ATMS aligns with the global laboratory animal welfare “3R Principle,” which stands for Replacement, Reduction, and Refinement. Its purpose is to promote the scientific, rational, and humane use of animals while respecting life and minimizing animal use wherever possible.
ATMS Dynamic Culture System
While humans constantly engage in physiological activity, can cell culture also evolve beyond static conditions? The ATMS system enables dynamic cell culture, maximizing experimental efficiency in limited space while reducing the need for animal testing.
Key Features
- Compatible with a wide range of cell types and customizable stretching/frequency parameters
- No vacuum oil required, minimizing experimental contamination
- User-friendly operation; expandable inside standard incubators
- Sterilizable accessories to reduce operational contamination risk
- Optical-grade, affinity-bound silicone culture membrane enables observation via immunostaining or fluorescence microscopy
