Quality Systems
The Biomanufacturing Center in Hopkinton, MA offers an established Quality System to support production of early phase bulk drug substance programs. Our systems are compliant to applicable portions of 21CFR Parts 210, 211, 600, 610, and 820 as well as ISO 13485.
Close collaboration exists between our analytical development and our QC teams, all operating under QA and OPS oversight to further streamline feasibility/development and final qualification of custom methods. A standard analytical package for an antibody or protein therapeutic include:
- Approved Quality Manual
- Experienced Quality Assurance Team
- Customized creation of client records and specifications
- Independent QA batch review and disposition
- Established approved supplier list
Our systems are compliant to applicable portions of 21CFR Parts 820 as well as ISO 9001:2015.