The American Red Cross is the largest single provider of apheresis collections for cellular therapy in the United States with 62 collection sites and growing.
• All sites are registered with the FDA as HCT/P collection establishments
• Access to our nationwide network of products, services and industry recognized medical proficiency
• American Red Cross’ expertise in providing hospital-based therapeutic apheresis and stem cell collections services for in-hospital collections
• Ability to perform initial cell processing at any of our five full-service stem cell labs
• Product can be shipped fresh or frozen
• Physician and patient education on leukapheresis procedures
• Venous assessment
• Per procedure review of CBC results and relevant medical history
• CBC sample draw and testing (if multiple procedures will be performed)
• Central venous catheter care, including dressing changes
• Provision and utilization of heparin to lock catheter
• Post-procedure feedback to prescribing physician
• Packaging of product according to manufacturer’s specifications
American Red Cross offers donor MNC collections, known as Leukopacks
• May be used for multiple purposes, from training through bench research and clinical usage
• Our nationwide network of collections locations allows us to access donors across the country
• MNCs are collected under an American Red Cross IRB-approved protocol and/or under a customer’s protocol
• Perform HLA testing in-house on many of our donors
• Ability to perform initial cell processing, freezing and storage at any of our five full-service stem cell labs
• Product can be shipped fresh or frozen
• Full donor eligibility is completed by health history and physical assessment as required
All potential Leukopack donors undergo a pre-screen process to determine their eligibility. Tests performed include:
• Infectious Disease panel
• Complete Blood Count
Potential Leukopack donors who have passed the pre-screen process are entered into our donor database and may be recruited to support your future Leukopack needs. HLA typing may be performed on donors to meet specific customer requirements. Additional HLA testing is available upon request.
Depending on your needs, the American Red Cross will perform the collection according to our standard parameters orbased upon your specific requirements. In addition, we have the ability to collect utilizing any FDA-approved device.
The American Red Cross has five full-service stem cell labs, at which we perform processing, freezing and storage of stem cell products. This allows us to perform initial processing of MNC products collected, if requested by the customer. This processing is done to the customer’s specifications. If needed, the products can be frozen prior to shipment or be stored at a Red Cross facility.
The American Red Cross can also provide product testing results, including:
• Sterility
• Cell counts
• Viability
A Certificate of Conformance and a Certificate of Analysis are issued to you with each Leukopack.
In addition to the delivery of MNCs, whether autologous or allogeneic, the American Red Cross also offers contract manufacturing services. In our full-service stem cell lab in Philadelphia PA, we have two clean room spaces, in which we perform contract manufacturing to the exact specifications provided by our biotechnology clients. Our contract manufacturing staff has expertise in working across different types of drug therapies, using blood products collected by the American Red Cross or other third parties.