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
Clinical research support solution
When you need drug and cellular therapy research support, we have access to the world’s leading transplant-related clinical research programs and clinical trial networks.
We never let up on our efforts to improve the science of cellular therapy.
Our parent company, NMDP/Be The Match, conducts research through their research program, CIBMTR® (Center for International Blood and Marrow Transplant Research®), in collaboration with Medical College of Wisconsin (MCW).
This global collaborative effort supports research efforts of all sizes, and has resulted in more than 1,000 peer-reviewed publications and more than 200 active studies, driving the quest to save more lives.
We provide drug and cellular therapy researchers with infrastructure and expertise in end-to-end clinical trial development, management and analysis.
The Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI BMT) within the CIBMTR supports researchers investigating cellular therapies, not limited to hematopoietic cell transplantation.
We provide end-to-end solutions, from assisting with protocol development and site selection and management to a robust software package to manage and collect data, including adverse event data, to sample management and an outcomes database.
Study infrastructure is in place for multicenter prospective Phase I-III trials and other studies requiring statistical and/or logistical support.
Our customizable clinical research support solution includes:
Observational Research Support
- Provide support services to help you develop protocols
- Collect, extract and summarize data on clinical outcomes
- Provide expert clinical, immunobiological, bioinformatic and statistical advice, and data management and analysis
Clinical Trial Support
- Provide study design support
- Recruit and manage clinical trial sites through our network of transplant centers
- Provide correlative study sample collection, processing, storage and testing support
- Assist with regulatory submissions prior to trial initiation
- Manage clinical trials, with impeccable record of recruiting trials on time and within budget
- Provide access to BioTherapies and the CIBMTR research scientists and biostatisticians who can provide clinical and statistical consultation and logistical support, as well as compile customized support for regulatory submission
- Provide sample storage in our biorepository
When you need research support to help you refine your product, our researchers have the experience you need.
Our relationship with the CIBMTR and NMDP/Be The Match gives you access to M.D., Ph.D., and M.S.-level experts in clinical cellular therapy, immunobiology, bioinformatics and biostatistics who conduct practice-changing research. Case in point: Dr. Mary Horowitz and her team. They've opened more than 13 clinical trials through RCI BMT that have accrued more than 28,000 patients, and 38 clinical trials through the BMT CTN that have accrued more than 9,000 patients.
Cell sourcing solution
When you need donor cells consented for research, clinical or commercial development for your allogeneic therapy, we have unparalleled expertise to identify and consent donors for the cells that meet your needs – and the infrastructure to acquire those cells for you.
Finding fully consented donor cells that meet your specific needs isn’t easy.
Through the Be The Match Registry®, we have access to nearly 16 million U.S.-based potential donors and 225,000 umbilical cord blood units with both rare and common haplotypes.
Our team has unique knowledge in customized algorithm development, registry access and analysis, genetic markers and histocompatibility.
We can conduct bioinformatics analyses of the registry along many axes including: genetic markers (HLA, ABO, KIR), demographics (sex, age), geospatial analysis and others.
Whether you’re looking for cells representative of large segments of the population or those that are unique, we can filter and optimize specific criteria to help you identify the right unrelated donors or cord blood units to provide consented cells as you research and develop your cell therapy and bring it to commercialization.
We have the experience to take you from identifying donors to acquiring consented donor cells that meet regulatory and legal requirements for research, clinical or commercial development.
After our team has helped you identify compatible cell source material, we assist in your protocol design and development, recruitment materials and regulatory compliance, and guide you through the institutional review board (IRB) process. We also 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:
Immunogenetics and Bioinformatics Support
- Provide unique knowledge in customized algorithm development, registry access and analysis, genetic markers and histocompatibility
- Identify the most genetically compatible cell sources for early stage therapy development – including cytotoxic T-cell (CTL) therapies, induced pluripotent stem cell (iPSC) therapies, NK (natural killer) cell therapies and others – for all stages of development
- Offer customized matching using our peer-reviewed search engine, HapLogicSM, to model and optimize allogeneic cell banks
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
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
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
- Developing and managing 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
- Conducting audits to ensure ongoing compliance
- Providing ongoing and ad hoc training and associated documentation to ensure continued compliance
- Managing the delivery of donor cells from the collection center to the manufacturing location
- Providing regulatory support to ensure compliance with FDA Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP)
When you need a cell collection network, we can build and manage it for you.
Amy and her team have deep and long-standing relationships with apheresis centers throughout the country through our parent company, NMDP/Be The Match. These relationships allow us to build a cell collection network that meets your needs, while you concentrate on developing effective therapies for patients.
Cell therapy supply chain delivery solution
Establishing a reliable cell supply chain is critical to successfully delivering a cellular therapy, such as chimeric antigen receptor T-cell (CAR-T) therapy.
You may encounter unexpected challenges when a patient or donor is at the center of your cellular therapy.
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 these challenges requires truly personalized patient management, not just 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.
This allows us to quickly and reliably facilitate personalized small-batch therapies with high-quality and low cost.
Our case managers have the experience to create and handle all aspects of the 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 your cell therapy depends on a reliable supply chain, we have the experience to deliver.
Ray understands the challenges that come up when you’re transporting cells around the world, and they need to arrive on-time. When the unexpected happens—from natural disasters to world events like 9/11—he develops the plans that ensure cells get where they’re needed, when they’re needed. And he’s been doing it for more than 10 years.