NuBiyota’s CMC platform is based on the creation of a strain bank of beneficial microbes isolated and purified from this donor, which have been carefully curated and stored. This ensures a highly standardized composition of microbes across the entire production process.
NuBiyota’s proprietary approach includes a unique culturing process enabling the creation of multi-strain formulations.
NuBiyota has focused on developing the optimal combination of microbes for the restoration of ecosystem function, encapsulating multi-strain compositions at production scales, which uses methods developed to adhere to GMP standards.
1. Donor Selection
Extensive search for healthy donor that shows sample efficacy across different indications suitable for FMT.
2. Strain Bank Establishment
Remove pathogens Select optimal strains Isolate, purify and identify strains
3. Culture
Culture strains. Methods to enhance growth of more fastidious strains. Create defined complex community.
4. Lyophilization
Freeze and lyophilize. Microbes are stored in a freeze-dried state to ensure functionality.
5. Encapsulation of ecosystems
Focus on ecosystem functionality. Develop multiple generations for various indications.
6. Scale Production
Standardize product. Regulatory approval.
Consistent, Scalable and Effective
We have developed several drug products, each from an individual ‘super-donor’ to preserve ecosystem function
We have been able to culture even difficult-to-grow strains to create unique compositions with high efficacy
Multi-strain approach for complete microbiome restoration
We use a standardized process to ensure consistency and reproducibility
Our products undergo strict safety profiling and are scalable to GMP production standards
We produce high quality drugs with optimal stability