Interview: Optimizing the Cell Collection Network to Support the Commercialization of Cell and Gene Therapies
Featuring Amy Hines, RN, BSN, Director of Collection Network Management, Kimberly Kasow, DO, and Sandra Hoffman, MT (ASCP) SSB, CQA (ASQ)Download
Cell therapy supply chain delivery solution
When a patient’s therapy relies on cells arriving intact and when and where they’re needed, high-touch end-to-end supply chain experience matters. Our experience allows us to quickly and reliably facilitate personalized small-batch therapies with high-quality and low cost.
This isn’t your average supply chain and drug manufacturing challenge.
Coordinating cell therapy logistics is extraordinarily complex. Cell therapies like chimeric antigen receptor T-cells (CAR-T) require rapid turnaround. And, you have to be ready for challenges traditional drug manufacturers don’t face.
Patients may become too ill for apheresis on the scheduled date, or the collection may not go as planned. Manufacturing of cell therapies might take longer than anticipated and manufacturing yields might be lower than ideal, requiring additional cell collection.
Overcoming challenges to deliver cells when and where they’re needed requires more than technology.
Our parent company, NMDP/Be The Match has 30 years of experience managing more than 80,000 hematopoietic cell transplants around the world.
Through that experience, we’ve learned that cell therapy logistics requires high-touch personalized patient management supported by technology. Because you’re treating a person, not just a disease.
In order to deliver the supply chain solution you need, the patient needs to be at the center of everything you do.
Our experienced case managers develop and manage all aspects of the patient case plan and troubleshoot unexpected disruptions that occur.
This high-touch, end-to-end patient management ensures the on-time and compliant transport of cells from the patient to the cell therapy manufacturer and back to the patient.
Our customizable cell therapy supply chain delivery solution includes:
Personalized Case Management
- Create and manage patient-specific management plans to achieve desired treatment timeline
- Coordinate and manage all aspects of the plan, from collection to manufacturing to delivery of the cell therapy to the infusion center, through the support of our case management staff and an underlying technology platform
- Troubleshoot disruptions and variability inherent to patient-involved therapies to ensure that patient care is delivered on time
- Provide services 24 hours a day, 7 days a week, 365 days a year
Cell Therapy Network Access
- Manage a network of more than 500 apheresis, transplant, blood and related centers for product collection and delivery that meets regulatory requirements and client specifications
- Conduct audits to ensure ongoing compliance
- Provide reliable and proven delivery of collected cellular materials from collection centers to manufacturing centers to infusion centers
- Supply shipment tracking and communication using BioTherapies’ proprietary technology platform, including chain of custody utilizing ISBT 128 labeling to provide unique and comprehensive coding methodology for each collection
- Offer regulatory support to ensure compliance with FDA Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP)
- Develop transport solutions based on client-specific needs (e.g., transport of both cryo-preserved and fresh product)
When challenges arise, our case managers know how to navigate them.
Our high-touch case management approach allows our patient case managers like Jane to quickly troubleshoot problems that arise. This ensures the compliant and on-time transport of cells to and from centralized manufacturing sites.
Cell sourcing solution
Our cell sourcing solution provides you with the expertise, processes and regulatory insight needed to acquire allogeneic donor cells fully consented for research, clinical or commercial use.
Acquiring consented donor cells with specific characteristics takes experience.
Through the Be The Match Registry®, Be The Match BioTherapies® brings you access to nearly 16 million U.S.-based potential donors and 225,000 umbilical cord blood units with both rare and common haplotypes. This donor pool can also be searched to find rare cell types for R&D and commercialization.
You need established processes for donor consent and cell delivery that meet regulatory and legal requirements for commercial development.
For 30 years our parent company, the National Marrow Donor Program® (NMDP)/Be The Match® has used an established process for identifying and consenting donors on the registry.
The experience we’ve gained allows us to find the donors you need, contact potential donors to explain the opportunity and facilitate full consent for research, clinical or commercial development.
Once we receive consent, we’ll help you manage your operational process, including cell collection and delivery.
Our mission is to save lives through cellular therapy. By extending our Registry and unique expertise to new and emerging cellular therapies, we can help save more lives and improve the quality of life for patients.
Our customizable allogeneic cell sourcing solution offers:
Diverse Source Material Access
- Manage the largest and most diverse donor registry in the world with 16 million HLA-typed donors
- Offer high-resolution HLA typing of rare and common haplotypes
- Provide a variety of cell types, including bone marrow, PBMC (mobilized) and whole blood
Regulatory Compliance Expertise
- Expertise in protocol development that ensures donor safety, informed consent and compliance with necessary regulatory standards
- Manage IRB protocol submission and review throughout the process
- Ensure compliance with U.S. and other applicable standards for cell therapy donor starting material
Personalized Donor Case Management
- Contact the potential donors to explain the opportunity and facilitate full consent for research, clinical and/or and commercial development
- Manage the donor workup process to ensure the donor is both medically suitable and willing to donate
- Perform necessary screening and testing for donor eligibility determination per FDA and other applicable regulations
- Schedule donation with our cell collection network and coordinate logistics after the cells have been collected
- Ensure the safety and privacy of donors by following strict internal standards, plus all applicable regulations from governmental agencies
Cell Collection Network
- Develop and manage a national network of apheresis and blood centers for diverse allogeneic product collection—including whole blood, apheresis products, mobilized peripheral blood stems cells or cord blood—that meets regulatory requirements as well as client specifications
- Conduct audits to ensure ongoing compliance
- Provide ongoing and ad hoc training and associated documentation to ensure continued compliance
- Manage the delivery of donor cells from the collection center to the manufacturing location
- Provide regulatory support to ensure compliance with FDA Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP)
When potential donors have questions, we have answers.
Kelly knows the kinds of questions potential donors may have. She’s been answering them for more than 15 years. As a donor case manager, Kelly has extensive knowledge in the donor consent process, and managing the steps from donor work-up to cell collection scheduling through delivery.
Cellular therapies registry solution
Once your cellular therapy is commercially available, the need to store patient samples and report quality outcomes data for regulatory purposes will continue for years after a patient has received therapeutic intervention.
We provide the infrastructure and the expertise to collect, store and analyze outcomes data at any time points required by regulatory authorities.
Collecting and maintaining outcomes data is something our parent company, the National Marrow Donor Program® (NMDP)/Be The Match®, has done for decades through its research program the CIBMTR® (Center for International Blood and Marrow Transplant Research®). In collaboration with the Medical College of Wisconsin (MCW), the CIBMTR securely collects and stores patient cellular therapy outcomes data and maintains long-term follow-up.
These data are routinely analyzed to help improve future outcomes for patients receiving cellular therapies, and can be further analyzed at any time points required by regulatory authorities.
Our cellular therapies registry solution includes:
Outcomes Data Collection and Analysis
- Provide customized data collection, secure data storage and custom data extracts
- Supply standard reports and analytics
- Offer scientific and statistical consulting for research design and data analytics
- Perform statistical analysis and interpretation
Biorepository Sample Collection, Storage and Analysis
- Collect patient samples per protocol requirements
- Process and store patient samples
- Retrieve samples and ship for analysis
- Facilitate centralized laboratory testing services and reporting