Starting material consistency, quality and regulatory compliance are key components to the successful manufacture of your autologous cell or gene therapy. That makes your collection network a critical part of your supply chain.
Our Collection Network Onboarding solution assesses a center selected for your network to make sure it has the infrastructure and capabilities to collect for your protocol. And we train the center to collect for your autologous therapy.
For cell and gene therapy companies with allogeneic therapies in development, Collection Network Onboarding is included as part of our Allogeneic Cell Sourcing service.
Our long-standing relationships allow for streamlined apheresis center onboarding and training
We have relationships and processes in place with apheresis centers across the country.
These established relationships, procedures and experience developed by the National Marrow Donor Program®/Be The Match® over 30+ years help us streamline and speed up the network onboarding and training process without sacrificing quality.
Our Collection Network Liaisons and Managers facilitate each step, from the capabilities assessment through first collection support. They work closely with you to understand your specific collection and processing requirements.
And they bridge the gap between sponsor and center.
Our experience using a distributed apheresis center model can help you efficiently expand your network when your autologous therapy moves into late-stage clinical trials and commercial use.
Efficiently onboard centers using our established process
Quality system audit (QSA)
Ensure the center has the quality systems in place for quality, consistent collections that meet regulatory standards.
Use the Be The Match BioTherapies Quality System Audit Program to streamline QSAs.
Develop and execute therapy-specific training for collection, labeling and material transport requirements.
Collaborate with sponsor to create therapy-specific collection manual for use by center.
Center infrastructure & capabilities assessment
Assess the center’s infrastructure and capabilities to collect for your protocol.
Test shipment to ensure the center has a run through of all the specifics for labeling and shipment.
First collection support
Provide refresher training and on-call support to answer last-minute question.
We offer our Quality System Audit Program (QSAP) to help streamline the QSA process
QSAP provides an opportunity to license apheresis center audit results for multiple centers at once. This saves you time and money.
Our ASQ-qualified auditors are experienced in auditing apheresis centers collecting for cell therapy protocols.
They conduct quality system audits for QSAP according to Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) requirements.
Not sure where to start?
Onboarding a network of apheresis centers to support your autologous cell therapy collections can feel overwhelming. You don’t need to do it alone. Let’s discuss your needs.
First-collection preparation though protocol-specific training sets centers up for success
Once our team has established that a center has the capabilities and quality systems in place to collect for your protocol, we begin the training process. Our training activities include:
- Curating and delivering client-required training using our optimized training methods
- Developing a therapy-specific collection manual
- Assessing center readiness and preparedness
- Providing an on-call team member to support critical events, including first collection and first shipment, in addition to subsequent events as needed
- Provide ongoing and refresher training
Our support for your Collection Center Network doesn’t stop with the first collection. We offer our clients a Collection Network Management service.
Because your supply chain initiates with starting material collection, these services are ideally combined with our Autologous Cell Therapy Supply Chain Management solution to align and streamline the full supply chain. Our Supply Chain Management team works closely with our Network team to seamlessly move the product through the rest of the process.
Network Onboarding deliverables you will receive
Documentation used to determine if a center has the proper infrastructure and capabilities for collection and all contact information
Quality system audit report
All audit information, including any corrective actions and remediations
Therapy-specific collection manual and additional training materials to be used by centers
Mock shipment report
Results of the mock shipment
Center release report
Final release of the center for first collection, including training records, audit closed notification and references to other Network Onboarding deliverables
Access additional services
Autologous Supply Chain Management
Coordination and optimization of the full supply chain from collection through therapy delivery.
Long-term safety and efficacy data collection and analysis for autologous and allogeneic cell therapies.
Frequently asked questions
Can you help us develop a collection manual for our autologous cell therapy?
Yes. Our Be The Match BioTherapies Apheresis Network team has extensive collection experience. They can work with you to develop your protocol-matched collection manual.
Can you help us determine the apheresis centers that will best match our protocol's needs?
Yes. We have worked with a wide variety of apheresis centers and will advise you on centers that may have the capabilities needed for your collection protocol.
During the COVID-19 pandemic, can you onboard apheresis centers remotely?
Be The Match BioTherapies has developed capabilities for the virtual onboarding, training and auditing of apheresis centers during the COVID-19 pandemic. Contact our team to discuss options for your company.
What role does Be The Match BioTherapies play in standards setting efforts?
Be The Match BioTherapies participates in several existing standards setting efforts. We work with a variety of stakeholders in the industry, including physicians, patients, apheresis centers, regulatory agencies and cell and gene therapy companies. This allows us to bring a unique perspective to these efforts. In addition, we bring the lessons learned in our 30+ years of experience facilitating hematopoietic stem cell transplants to emerging cell and gene therapy initiatives.
Let us put our experience to work for you
We understand the importance of consistent, high-quality cellular starting material for autologous cell therapies. We would value the opportunity to discuss your needs and how we can help.