Industry-leading experience in navigating cell therapy regulatory requirements
Strict regulatory compliance is critical to the success of cell and gene therapies. Cell collection specifications must comply with wide-ranging, and in some cases still evolving, domestic and international regulatory requirements and yield cell harvests that provide consistent, high-quality and compliant products for manufacture.
Our quality and regulatory experts have developed a deep understanding of the regulatory landscape over the last 30 years by supporting more than 86,000 domestic and international cell harvests for our parent company, the National Marrow Donor Program® (NMDP)/Be The Match®. Through close collaboration with global partners, our expertise in this area is continually evolving, as the cell and gene therapy industry advances.
All products managed by NMDP/Be The Match require compliance to:
- 21 CFR Part 211 Good Manufacturing Practice (GMP)
- 21 CFR Part 1271 Good Tissue Practice (GTP)
By building on our experience with products regulated under GMP and GTP, our regulatory specialists proactively collaborate with clients to overcome domestic and/or international regulatory challenges.
Global regulatory compliance is critical
Our team collaborates closely with clients to develop de novo collection protocols that meet both FDA and international regulatory requirements.
Examples of country-to-country regulatory differences for source material. Inconsistencies with FDA regulations identified in red.
Examples of international regulations that our team has successfully integrated into client protocols include:
- Therapeutic Goods Order No. 88 (Australia)
- CAN/CSA-Z900.1-17 (Canada)
- European Directives 2002/98/EC and 2004/23/EC (European Union)
Our quality and regulatory specialists support the advancement of cell therapies by:
- Understanding unique product requirements and supply chain
- Identifying applicable U.S. and/or global regulatory requirements
- Collaborating with clients to develop cell collection specifications that meet regulatory requirements
Collection Network Development & Management
By leveraging our established relationships with cell collection centers worldwide, we can identify the center(s) best-suited for collecting starting material for your therapy, and provide onboarding, training and center management specific to your needs.
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Learn how our regulatory team can support the compliance requirements of your cell or gene therapy.