Our Commitment to Quality
We are dedicated to manufacturing and delivering top-quality, consistent products and services in order to facilitate the speed of scientific breakthroughs.
Supplier and Raw Material Management
Quality and consistency of our products begin with the initial qualification of critical suppliers and control of raw materials. We develop quality agreements with our suppliers, confirm we have full traceability of our raw material, and actively ensure the resolution of any nonconformance.
Our quality system documentation is controlled using a software platform that is 21 CFR Part 11 compliant and production processes are executed by trained personnel using approved protocols and reports.
Equipment and Process Control
Critical equipment used for GMP manufacturing goes through standard IQ/OQ/PQ procedures and are routinely scheduled for preventive maintenance and calibration. Production processes are validated with approved protocols and reports.
ISO 13485:2016 Certification
With expertise in small lot custom media and compliance with ISO standards, we are committed to meet your unique needs. Nucleus Biologics is ISO 13485:2016-certified for the manufacture and distribution of media for the cell and gene therapy industry.
“As the rapidly growing cell and gene therapy industry matures, we must put tools in the hands of therapy developers that allow them to formulate, order, track, and manufacture media with transparency, quality, therapeutic potency, and cost in mind. We are committed to changing the paradigm.”
With multiple manufacturing facilities, we provide a vertically integrated solution from powder processing to complete liquid media manufacturing. Our products are manufactured under GMP conditions and governed by strict adherence to an ISO 13485:2016-certified quality system.
- Over 7,000 square feet of manufacturing space
- Segregated GMP, animal-cell free (ACF) manufacturing
- 2.5-million-liter annual capacity
- Five ISO 7 cleanrooms
- Two ISO 8 powder cleanrooms
- WFI spec water system with ozone generation system
- XiltriX environmental monitoring system
- Powder milling and blending