Established GMP Quality Management and Regulatory Support
Our USA based, state-of-the-art facilities in Saint Paul Minnesota are licensed by the FDA and include quality-controlled manufacturing spaces dedicated to production under animal-free conditions.
Certifications and regulatory guidelines include:
- ISO 9001:2015, ISO 13485:2016 certified facility
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
Experienced manufacturing of raw materials
Our teams have decades of experience in reagent development and IVD-certified manufacture, as well as a proven track record producing GMP-grade ancillary reagents for cell therapy clients.
Flexibility to fit into your processes
Start from an existing antibody or generate one from scratch. Customize vial size and formulation to streamline and de-risk your process. Scale up and scale out at your own pace. Tell us your needs – and we’ll customize your project.
Expert support for regulatory affairs
Use our dedicated team for support with process validation and regulatory affairs, to help your reagent transition from initial submission to market authorization. We’ll provide complete documentation every step of that way.