Leave message
Can’t find what you’re looking for?
Fill out this form to inquire about our custom protein services!
Inquire about our Custom Services >>
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark decision to phase out mandatory animal testing for monoclonal antibodies and other drugs. This transformative move aims to adopt New Approach Methodologies (NAMs) that are more efficient and better reflect human biology. By reducing reliance on animal testing, the FDA seeks to improve drug development safety and efficiency, accelerate the approval of new therapies, and promote a more ethical, human-relevant global research paradigm.
• Objective: Gradually eliminate mandatory animal testing in the development of monoclonal antibodies and other drugs, shifting toward more human-relevant alternatives such as AI-based toxicity prediction models, organoids, and organ-on-a-chip technologies.
• Scope: Effective immediately for new drug IND submissions. Sponsors are encouraged to submit NAM data to support safety assessments.
• Global Data Acceptance: Human safety data from countries with comparable regulatory standards will be accepted, reducing redundant animal testing.
• Regulatory Incentives: Companies providing robust, scientifically validated NAM data may benefit from streamlined FDA review processes.
• Upcoming Pilot Program: Within the next year, the FDA will launch a pilot program focusing on monoclonal antibody development driven by non-animal testing, aiming to gather data and experience to inform future regulatory updates.
The newly released policy underscores regulators' growing emphasis on human-relevant data and sends a clear signal to the industry: organoid-based human models are rapidly moving from basic research into critical roles in preclinical drug evaluation.
Organoids are lab-grown, three-dimensional mini-organs derived from human cells that closely mimic the structure and function of real human organs. They have shown clear advantages in toxicity testing, drug screening, and disease modeling. Compared to traditional animal models, organoids offer greater physiological relevance and predictive accuracy, positioning them as a key alternative technology in the future of drug development.
ACROBiosystems' brain, cardiac, liver, and intestinal organoids
ACROBiosystems is at the forefront of the organoid wave, staying ahead of industry trends with Organoid Toolbox. This comprehensive solution includes ready-to-use and cryopreserved iPSC-derived organoids, organoid differentiation kits, as well as customized organoid development, disease modeling, and analytical services—empowering drug discovery and disease research across the board.
Our featured products include:
Cardiac Organoids (Cat. No. CIPO-HWL002K) for assessing cardiac toxicity and providing early safety evaluation.Cerebral Organoids (Cat. No. CIPO-BWL001K), incubated with pre-formed fibrils (PFFs), are used to model neurodegenerative diseases, effectively recapitulating key pathological features of conditions such as Alzheimer's and Parkinson's disease.Liver Organoids (Cat. No. CIPO-RWL005K) for establishing non-alcoholic steatohepatitis (NASH) models and conducting drug metabolism studies.Intestinal Organoids (Cat. No. CIPO-IWL003K), offering an ideal in vitro model for studying intestinal immune responses and inflammatory diseases.We’re excited to introduce our exquisitely designed Organoid Pins, featuring a creative blend of cardiac, brain, liver, and intestinal organoids with animal and plant elements. This design symbolizes the important contribution of organoid technology in reducing the use of experimental animals.
Want one? Stay tuned to our organoid initiatives for a chance to win this exclusive gift!
>> Application of Tau PFFs and Alpha-Synuclein PFFs in Neurodegenerative Disease Research
This web search service is supported by Google Inc.
A-Z
