The National Institutes of Health has established the Standardized Organoid Modeling (SOM) Center at the Frederick National Laboratory for Cancer Research. This new initiative represents the first comprehensive effort to standardize organoid-based New Approach Methodologies (NAMs) at the national level.
Addressing a Critical Need
Organoid technology has shown considerable promise as a human-relevant alternative to animal models. However, the field has faced a persistent challenge: inconsistent protocols across laboratories lead to variable results, making it difficult to compare studies and validate findings.
The SOM Center’s mission focuses on developing validated protocols, establishing performance standards, and creating data-sharing frameworks to improve reproducibility. As these standards emerge, the expectation for consistent, well-characterized organoid systems will likely become central to publication, funding decisions, and regulatory acceptance.
What This Means for Research
This shift toward standardization has practical implications. Laboratories will increasingly need organoid systems that are:
- Validated with documented quality metrics
- Reproducible across batches and facilities
- Compatible with established screening workflows
- Aligned with NAM frameworks for regulatory consideration
Supporting the Transition
In alignment with the NIH Standardized Organoid Modeling (SOM) Center initiative, Lambda Biologics is advancing reproducible, human-relevant organoid platforms that meet the growing global demand for standardized New Approach Methodologies (NAMs). Our commitment to quality and comparability ensures every model we build supports the shift toward replacing and reducing animal use in research – and accelerating translational science with confidence.
Read more: Using Organoids to Understand the Human Body, Organ by Organ
Lambda Biologics’ Organoid Solutions: Adult Tissue and PSC-Derived Organoid Models for Drug Discovery
Drug development demands accuracy, speed, and relevance to human biology. At Lambda Biologics, we deliver advanced organoid-based platforms that replicate the complexity of human organs – empowering pharmaceutical and biotechnology companies to make better decisions, faster.
Cerebral Organoid | Midbrain Organoid | Skin & Hair Organoid | Intestine Organoid |


