The American Red Cross provides Leukopaks collected from unstimulated, non-mobilized healthy donors. Leukopaks can be shipped fresh or cryopreserved — with or without processing, based upon client preference.

We currently perform Leukopak processing, storage and cryopreservation at three full-service Cellular Therapy Labs across the country – Portland, OR, Philadelphia, PA, and Salt Lake City, UT. Our lab in Philadelphia also contains three cleanrooms for Leukopack processing. Processing can be performed according to American Red Cross’ standard processing procedures or in accordance with client-specific processing procedures. Resulting products are cryopreserved and stored in liquid nitrogen. Long-term storage is available upon request.

Each of our Leukopak customers are supported by a dedicated Client Relationship team at Biomedical Headquarters (BHQ) consisting of operational and quality leads. Our operational leads work with American Red Cross collection and processing sites across the country to ensure standardization in the provision of our Leukopak products, while our quality leads work with their counterparts at our clients to coordinate audits and lead any quality-to-quality communications.

Clients also have easy access to our apheresis collection and cellular therapy lab technical leads. These experts can provide guidance and feedback on how best to modify collection parameters and how to develop and implement specific processing protocols to ensure that our clients’ unique needs are met.  

Yes, we offer extensive internal testing capabilities and have established relationships with key external specialty testing providers. Our current range of testing includes IDT, CBC, HLA, immunophenotyping, sterility, endotoxin and mycoplasma testing, among others. We are also experienced in bringing on new testing partners to meet unique testing needs of our Leukopak clients.

The American Red Cross does not currently perform cell counts on fresh Leukopak products. Using our standard collection parameters, each full Leukopak is anticipated to contain a minimum of 9.5 billion cells.

American Red Cross has a significant distribution of collection sites, donors and staff across the country. While we currently perform Leukopak collections at five sites, we have an additional 57 sites within the American Red Cross system at which we currently perform autologous MNC collection procedures and can readily upscale production as needed. Our nationwide network of collection sites, donors and staff provides us with significant expansion capability for Leukopak collections across the country.

We ensure material consistency by strictly adhering to a set of standard national collection and processing procedures, a single Quality Management System, and any unique specification provided by the client, ensuring that the collection and processing procedures, and all aspects of support for those procedures, are as standard as possible.  

The quality of our Leukopak products begins with our healthy donors. All potential Leukopak donors undergo a thorough pre-screen process, including infectious disease (IDT) and complete blood count (CBC) testing, as well as completion of a thorough Healthy History Questionnaire. Those donors cleared to participate in our Leukopaks program undergo repeat IDT and CBC testing, as well as completing the Health History Questionnaire and health assessment at each pre-screen appointment and on the day of collection.

The American Red Cross also maintains a strict adherence to a standard national procedure for our Leukopak collections—a single Quality Management System, and any specific client requirements, ensuring that the standards for Leukopak collection and all aspects of support for that procedure have been followed.

Normally we request two-week’s advance notice for scheduling an ad hoc Leukopak collection. However, stat requests—those with less than two weeks’ notice-- are also welcome. The American Red Cross will provide feedback on the ability to meet a specific stat request within 24 hours of receipt of such request. Regular standing orders can also be established, based upon client preference.

Yes, we provide custom services, including adhering to select collection parameters, such as Total Blood Volume (TBV) to be processed and autologous plasma add-back or separate collection. In addition, we provide a wide range of additional testing services and can meet specific additional donor requirements, such as donor BMI, smoker status and CMV status, among many others.

We also offer specialty processing and cryopreservation services to meet client needs. Leukopaks can be processed utilizing the American Red Cross’ standard processing protocol or in accordance with clients’ individual processing procedures.

Yes, the American Red Cross can recall specific donors at the request of the client.  

We provide Leukopaks for use across the United States as well as internationally. Leukopak collections are currently performed at American Red Cross sites in Long Beach, CA, Atlanta, GA, Gahanna, OH, Portland, OR, and Philadelphia, PA. These five sites provide same-day delivery to clients within a select radius, depending upon couriers, and can provide next-day delivery to all clients within the United States.  

 The American Red Cross performs autologous mononuclear cell (MNC) collection procedures utilizing either the Spectra Optia or the Fresenius Kabi Amicus device. These collection procedures are performed by trained American Red Cross RN staff, operating under a single national collection procedure and a single Quality Management System. American Red Cross staff are accustomed to performing autologous MNC collection procedures in accordance with our clients’ leukapheresis manuals.

American Red Cross staff who perform autologous Mononuclear Cell (MNC) collection procedures undergo standard training on our national autologous MNC collection procedure, as well as standard training related to any supporting procedures. Clients typically provide training to American Red Cross staff on the specifics of their leukapheresis manual, including training on packaging and shipping of the collected cells. All training, including training provided by the client, is documented within the American Red Cross’ Learning Management System.

The American Red Cross can perform leukapheresis at any of our 62 fixed site locations across the country, as well as in hospital locations, and Principal Investigator sites.

Yes, multiple aspects of autologous MNC collection procedures can be customized, including parameters such as the number of Total Blood Volumes (TBVs) to be processed, equipment type, and autologous plasma add-back or separate collection. In addition, we offer specialty services including special testing (patient/subject or product), Central Venous Catheter (CVC) dressing changes, and educational materials for both physicians and patients/subjects on leukapheresis.

The American Red Cross has agreements in place with key testing vendors to provide testing services to our autologous MNC clients. The most common testing performed is Infectious Disease Testing (IDT) and Complete Blood Count (CBC) testing, for which we utilize Creative Testing Solutions and Quest Diagnostics, respectively.

 As autologous MNC products are collected from patients or subjects enrolled in a clinical study, the resulting cell counts of the products can vary based upon the patient or subject’s condition. The American Red Cross maintains a strict adherence to a standard national procedure, a single Quality Management System, and our clients’ leukapheresis manual.  

The American Red Cross can typically begin performing autologous MNC collection services within 4 – 6 weeks following execution of a contract for the services. The exact timeframe is dependent upon the training to be provided to American Red Cross staff by the client, as well as any new services and/or customizations that are being requested, such as implementation of a new test on the product.

Our autologous MNC customers are supported by a dedicated Client Relationship team at Biomedical Headquarters (BHQ). This team consists of operational leads and quality leads. The operational leads work with American Red Cross sites across the country to ensure standardization in the provision of our autologous MNC collection services. Our quality leads work with their counterparts at our clients to coordinate audits and lead any quality-to-quality communications.

Prior to clearing a patient/subject to move forward with leukapheresis, an American Red Cross Regional Medical Director reviews the patient’s/subject’s CBC test results and History and Physical (H&P). These regional Medical Directors are available to support prescribing physicians and local Principal Investigators throughout the country with education on leukapheresis and feedback on specific patients/subjects. Also, our Executive Medical Director for Direct Patient Care Services is available for consultation at any time.

 Products can be shipped domestically and internationally. The majority of our autologous MNC customers arrange for couriers to pick up and handle shipment of the collected products.

Our Generic Buffy Coat product is manufactured in Columbus, OH, and our Specialty Buffy Coat product is manufactured in Philadelphia, PA. Same-day delivery is possible for Specialty Buffy Coat product clients in reasonable proximity to Philadelphia, PA.  

 The Generic Buffy Coat and the Specialty Buffy Coat are both buffy coat products manufactured from a whole blood collection. Both products are ~50 ml and typically contain <1 billion mononuclear cells.

The difference is that specialty products provide non-identifying information related to donors including age, gender, BMI, and smoking status. Clients of the Specialty Buffy Coat products may also specify donor requirements for the products they receive and may also request a recall of specific donors for a future Leukopak product. Generic Buffy Coat products are not provided with this information and as such, generic products are selected based upon specific donor requirements.  

A Buffy Coat product is manufactured from a whole blood collection, is ~50 ml in volume, and typically contains <1 billion mononuclear cells. A Leukopak is a mononuclear cell product collected via a leukapheresis procedure. The resulting Leukopak product is ~250 ml in volume and typically contains >20 billion mononuclear cells.

Our Buffy Coat products are for Research Use Only.

We currently perform contract manufacturing services in dedicated cleanrooms at our Philadelphia site. Depending upon client needs, we can utilize existing cleanroom space as-is or with minor modifications; we can also build out new cleanroom space to meet unique client requirements.  

We have performed contract manufacturing services for multiple biotech/pharma companies engaged in RUO activities and clinical trials.  

Contract manufacturing services are currently performed in dedicated cleanrooms at our Philadelphia site. By leveraging our fixed site infrastructure and cellular therapy staff in other geographies, implementation of contract manufacturing services may also be possible at other American Red Cross facilities in Portland, OR and Salt Lake City, UT.

Typically, a technology transfer process will take between two and six months to accomplish. The exact timeframe will depend upon your specific process needs and --=the complexity and resource requirements related to the processes to be transferred.  

In addition to the manufacturing of your cellular therapy product, we can provide supporting products and services. These include the provision of required blood or Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), specialty collections, a wide range of testing, and performance of specialized qualification assays on the manufactured product.