Be The Match BioTherapies is powered by the National Marrow Donor Program®/Be The Match®, an organization that has established leadership throughout the last 30 years in the management of marrow and apheresis center networks.
The organization harvests bone marrow and hematopoietic stem cells for transplant from more than 6,000 donors each year, and more than 86,000 donors since 1987.
Our Be The Match BioTherapies Collection Network team builds on these relationships and the unique knowledge of cell collection standardization practices to support companies developing and commercializing cell and gene therapies.
We build and manage large-scale collection center networks for cell and gene therapies
Our team has implemented a standard set of processes to ensure consistent, compliant and high-quality cell starting materials are collected and provided to contract manufacturers.
Utilizing this proven, multi-step process, we identify the apheresis centers, marrow collection centers and/or cell therapy processing laboratories best-suited for specific cell harvest protocols, and audit and qualify each center. After centers pass specific qualification criteria, we provide onboarding, training, re-auditing as needed, performance monitoring and ongoing center management, based on established, standardized approaches that minimize the resource burden on the heavily-utilized collection center infrastructure.
Center qualification activities
- Initiate supplier questionnaire
- Perform initial onsite audit for compliance to GMP and GTP regulatory requirements
- Collaborate with center to address audit findings
- Close audit when corrective action is implemented and approved
- Execute a Quality Agreement
- Re-audit every 2 years
- Conduct surveillance audits as needed
- Understand specific client collection and processing requirements
- Identify and contact collection centers best suited to meet specific therapy needs
- Schedule initial onsite audits at identified centers
- Develop standard operating procedure (SOP) templates and job aids to promote standardization
- Assist with coordination of Service and Quality Agreements
- Curate and deliver initial Be The Match BioTherapies and client-required training
- Provide onsite Collection Network team member to support critical events, including first collection and first shipment, in addition to subsequent events as needed
- Assess center readiness and preparedness regularly, and provide ongoing and refresher training
Ongoing management activities
- Monitor availability among network sites to proactively identify scheduling concerns
- Ensure completion of all required documentation on day of collection
- Perform audits for necessary regulatory compliance requirements, including GMP and GTP, as required by client
- Identify opportunities for process improvements and implement best practices to improve quality and efficiency
- Document and investigate quality incidents and provide reports to client