You need a stable source of healthy, screened donors to decrease your potential for supply risk as you scale. Any misstep means delays in your allogeneic cell or gene therapy development.
But our experience has shown it takes more than a donor pool to source high-quality starting material and efficiently advance your therapy to market.
You need a partner with the expertise to identify the right donors from an expansive donor pool that match the characteristics you need. One that can contact, consent and educate donors. And oversee, schedule and monitor GMP-compliant leukopak collection and delivery.
Our Cell Sourcing service for allogeneic cell or gene therapies offers the reliability you need.
Are you developing an allogeneic cell therapy using cord blood as a starting material? We offer a central point of access to fully characterized cord blood units that simplifies acquiring the units you need. Access the details.
Our large, diverse donor registry allows us to therapy match material at a greater scale
We help you obtain high-quality cellular source material for therapy development and commercialization through the most diverse registry in the world, the Be The Match Registry®. Our clients have access to nearly 7 million genetically diverse potential donors from across the United States. These donors are part of an overall registry database of more than 41 million members worldwide. This provides you with access to a genetically diverse set of volunteer donors across the United States.
A large donor pool is a critical factor in the scalability of therapy-matched starting material. This is true even for common donor characteristics. As you add therapy-specific eligibility requirements, your pool of potential donors significantly narrows.
Examples include:
- Health authority and medical suitability requirements
- Viral positivity/negativity
- Specific HLA type, ethnicity or blood type
- Donor willingness and availability to donate in the timeframe needed
The more attributes you require, the larger your starting donor pool must become.
We use our sophisticated search and match capabilities developed over 35+ years to identify the donors that match the characteristics you need.
Our immunogenetics and bioinformatics team offers consultation for determining the impacts of HLA characteristics on your therapy as well as population modeling. Access information on our Consulting Services for cell and gene therapy sponsors.
How can we help you?
We’re ready to discuss your cell sourcing needs for your pre-clinical, clinical and/or commercial cell therapy development.
Diverse donor registry. Unparalleled experience.
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Comply with varying guidance from U.S. and international regulators
Donor requirements vary by country. And cell and gene therapy developers commonly pursue marketing authorization for their therapies in multiple countries.
You need a partner that understands how to develop processes and collect in accordance with domestic and international regulations. If your cell bank does not meet all regulations, your therapy development may be delayed as you are forced to start over.
When you partner with Be The Match BioTherapies®, you have access to our team of experienced regulatory and cell collection experts. They’ve gained their expertise over 35+ years of facilitating global deliveries of cellular products, primarily for hematopoietic stem cell transplantation.
We collaborate with you to develop processes in accordance with U.S. and international regulations
Our leukopak collections comply with applicable FDA regulations. This includes 21 CFR Part 211 – Good Manufacturing Practices (GMP) and 21 CFR Part 1271 – Good Tissue Practices (GTP).
Our quality and regulatory teams have worked with many clients to support international compliance of their material. This includes supporting collections complying with regulations for:
- Health Canada
- European Medicines Agency (EMA)
- Australia’s Therapeutic Goods Administration (TGA)
We provide you with customized documentation, such as:
- Donor consents
- Product specifications
- Certificate of analysis
- Certificate of compliance
- Donor eligibility forms
We understand key components to help ensure compliance with varying regulations, including the use of uncompensated donors
Cellular material collected from compensated donors may not be usable for final drug products intended for market in many developed countries.
Several key international regions either strongly emphasize or require the use of voluntary, unpaid donors for cellular therapies. They include the European Union, Canada and Japan.
Be The Match BioTherapies does not compensate donors to ensure the broadest possible use of the eventual therapies. In addition, non-compensation of donors optimizes safety for both donors and patients.
Connect with us
Discover how you can rely on our team to minimize your risk and deliver high-quality source material to you the first time.
Get end-to-end support from donor identification to cell or therapy delivery
Once you have worked with our team to identify potential donors for collection, our experienced team begins the donor outreach process. We take extensive steps from donor engagement through the donation process to deliver high-quality source material.
Our team:
- Contacts the donor and provides donor education
- Manages all necessary screening and testing for donor eligibility determination, including medical clearance
- Provides documented assurance of donor suitability to participate
- Obtains full consent from donor for research, clinical and/or and commercial development
We will reach out to a donor if a repeat donation is requested. However, we do not recommend relying on the use of a dedicated donor pool. This helps to lower your risk and ensure scalability in allogeneic starting material.
Our support doesn’t stop until your source material is collected and delivered
Identifying and clearing donors for collection is just the first step. Just as critical: the collection and delivery of consistent, high-quality source material for your allogeneic cell therapy product.
Our experienced Cell Therapy Supply Chain Managers coordinate with all stakeholders involved in the collection and delivery of the starting material and manufactured allogeneic therapy.
They work closely with our managed logistics team. Together they develop appropriate cell collection, transport and delivery schedules, and logistical plans within the required parameters.
Our teams closely monitor every step—from collection to source material transport and delivery to the manufacturer and therapy delivery to your cell bank.
A Cell Therapy Supply Chain Manager is available 24/7/365 for emergency support and to troubleshoot potential issues.
This ensures reliable delivery while maintaining the quality of your sensitive cellular source material and manufactured therapy.
End-to-end support for cord blood shipments
Working with an experienced team is just as important for cord blood shipments as starting material shipments from adult donors. Learn how we can support your team in sourcing and delivering cord blood units.
Our geographically diverse collection network helps ensure quality collections at scale
Allogeneic donor collections occur at our contracted Be The Match BioTherapies Collection Network sites. Based on our knowledge of a center’s capabilities, we determine the best-suited centers to meet your therapy’s needs.
We provide extensive onboarding and therapy-specific training to meet consistency, quality and regulatory compliance standards.
Our team monitors key performance indicators and quality incidents. When quality incidents occur, we analyze the data and work with the center on quality incident resolution. Our team conducts refresher training at a center as needed. Our goal is to ensure ongoing collection quality.
What is the advantage of using a contracted network of partners instead of a small set of owned centers? With our large network of centers located throughout the U.S. we can:
- Grow the number of centers collecting for your product as your volumes expand
- Align your therapy-specific needs with the centers that are best able to meet your needs
- Work with you to align your collection procedures with best practices
- Shift collections to a different area of the country if incidents occur that prevent collections in a specific location—for example, COVID-19 hotspots during the pandemic
Through the National Marrow Donor Program® (NMDP)/Be The Match®, we’ve successfully used this distributed partner model to support the global facilitation of allogeneic hematopoietic stem cell transplant.
Let’s talk
We’re ready to discuss how we can help you obtain the source material you need to support your allogeneic therapy.
Access additional services
Cord Blood Unit Sourcing
Comprehensive visibility into the domestic CBU inventory and simplified sourcing.
Supply Chain Management
End-to-end coordination and oversight of your autologous cell therapy supply chain.
Frequently asked questions
What types of starting material can Be The Match BioTherapies provide allogeneic cell therapy developers?
We most commonly supply MNC-A, PBSC, whole blood and cord blood units. Currently, we do not supply adipose tissue. Contact us if there are other blood-derived materials you wish to collect for your therapy.
Do you compensate allogeneic donors?
Be The Match BioTherapies does not compensate allogeneic donors. We support voluntary, unpaid donations for clinically used cellular materials and products. This aligns with the policy of the NMDP/Be The Match. We believe the use of non-compensated donors promotes donor and patient safety.
In addition, it aligns with international requirements and accreditation standards. Many international regions strongly emphasize or require the use of voluntary, unpaid donors for cellular therapies. Non-compensation allows for the broadest use of a client’s allogeneic therapy.
What information can you provide about the donors on the Be The Match Registry?
We have HLA information on all donors, as well as date of birth, race/ethnicity and gender. Additional characteristics, such as CMV status, may be available for subsets of the registry. Contact us to discuss your specific needs.
Why is it so important to have a large donor starting pool for allogeneic cell therapy clinical development? Which factors have the biggest effect on donor pool size?
Having access to a large donor pool is important to allogeneic cell therapy clinical development to help ensure scalability in sourcing healthy donor starting material. This is true even for common donor characteristics.
The number of study-specific attributes can have a significant impact on the needed donor pool size. The more donor attributes a therapy requires—such as viral positivity/negativity, specific HLA type, race or blood type—the larger the pool required.
As you add eligibility requirements, healthy authority and medical suitability requirements, study suitability requirements, and donor willingness to donate in the timeframe needed, your pool of potential donors will narrow.
Download Donor Pool Size Matters for Allogeneic Cell Therapies for additional details.
Can you provide repeat donors?
If the donor is willing to participate, we can obtain repeat donations. However, to ensure scalability in starting material, we do not recommend relying on a dedicated donor pool (sometimes referred to as super donors).
What is the advantage of using a contracted network of partners (i.e., apheresis centers, testing labs and clinics) instead of using internally owned centers?
The NMDP/Be The Match has successfully used a contracted network model for more than 30 years for the facilitation of hematopoietic stem cell transplant. By using this distributed partner model for Be The Match BioTherapies clients, we can support a large volume of allogeneic donors in diverse geographic regions. This also allows us to align your collection requirements with the centers that have the needed capabilities.
Which source material regulations do you comply with?
Allogeneic donor source material regulations are country dependent. We comply with all U.S. FDA regulations for cellular source material, including 21 CFR Part 211 (GMP) and 21 CFR Part 1271 (GTP).
We will collaborate with you to develop protocols that will meet international regulatory requirements that will support your intended markets. Our quality and regulatory teams have supported collections complying with Health Canada, EMA and TCA regulations.
Does Be The Match BioTherapies consent allogeneic donors to use their cells for pre-clinical, clinical and/or commercial cell therapy development?
We work with each client to develop appropriate study-specific consent that will cover all intended uses, including pre-clinical research, clinical trials research and/or commercial use of the cellular source material.
Are allogeneic donors for cell and gene therapy considered research subjects?
In many cases, it is unlikely the donor will be considered a research subject. However, this will depend on the particular study and collection. Our Be The Match BioTherapies team can work with you to determine if the donors for your study are research subjects. If so, we can help you develop materials to obtain IRB approval for the collections.
Can you store cellular source material or the final allogeneic cell therapy?
We currently do not have storage capabilities for allogeneic cell therapy products.
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We know you have questions about us. We’d like to know more about your therapy, too. Let’s get the conversation started.