Leukopaks

The quality of our leukopak products begins with our healthy donors. Through its national Specialized Donor Program, the Red Cross maintains a large, and diverse network of IRB-consented donors that can be actively recruited and recalled to support your current and future leukopak needs.

• All potential leukopak donors undergo a thorough pre-screen process to determine their eligibility, including standard infectious disease testing IDT Table 1 and complete blood count (CBC) testing, as well as completion of a thorough Healthy History Questionnaire
• Accepted donors, managed within the Specialized Donor Program, undergo repeat IDT and CBC testing, as well as completing a health assessment at each pre-screen appointment and on the day of collection
• Optional pre-and post- collection questionnaires offer further useful donor insights that can be used to limit product variability and optimize process and therapy development
• HLA typing and KIR testing can be added to allow for more detailed donor characterization and specific donor selection criteria such as BMI, ethnicity, CMV status, age, and lifestyle can be identified

Through our standardized collections and processing procedures and strict adherence to protocols approved by our in-house IRB, Red Cross can help limit variability and ensure consistency in your starting materials.

• The Red Cross operates under a single Quality Management System, including cGMP-production and cellular therapy lab/clean room processing and freezing activities
•  All apheresis collections in support of cellular therapy are performed using national procedures
• Our clients need only audit one QMS and one set of national procedures - local site audits can then be limited in scope, saving time in the audit process

Our Red Cross team of experts are ready to provide you with customized solutions— quality leukopaks, hands-on support, donor selection services, nationwide collections capabilities, processing/cryopreservation, and testing and typing services— helping to ensure consistency in your key raw material sourcing and efficiency throughout your development process.

Specific client-directed parameters and procedures can be implemented to meet your unique needs. Through your dedicated technical team, Red Cross can guide the development and delivery of customized solutions beyond apheresis and processing activities, to include donor selection capabilities on factors such as BMI, ethnicity, age, lifestyle, as well as extensive testing and typing services. Our experience and expertise help us design and implement customer specific collection protocols for leukopaks to allow you to efficiently meet your development timelines.

• Customization of apheresis procedures can encompass specific client requirements—equipment utilized, total blood volume to be processed, target volume of final product, target cells to be collected and addition of autologous plasma
• Processing services can be customized to reflect specific cell targets, supplies and/or equipment utilized in cell separation, as well as customized leukopak aliquoting and cryopreservation
• Dedicated cleanroom buildout and maintenance options available to meet your specific manufacturing requirements

Through our established testing partnership and in-house specialty labs, the Red Cross can perform the routine and complex testing you require.

• As part of the routine pre-screen process, we perform standard infectious disease testing and complete blood count adherent to FDA and AABB requirements
• HLA typing, KIR testing, and additional specialized infectious disease testing may be performed on donors as requested to meet specific client requirements
• Single source for all desired product testing, including immunophenotyping, cell count, cell viability, sterility, endotoxin, and mycoplasma testing, among others

Cell processing and cryopreservation are critical steps that can drive successful development and clinical and commercial manufacture of allogeneic cell therapies. This is especially true when there is a need to preserve cell viability for longer periods of time than that of fresh leukopaks, particularly when shipping product abroad or if long-term storage is necessary. Our full-service cellular therapy labs across the country perform processing, freezing, and storage of leukopak products per established Red Cross protocols or client protocols.

If needed, leukopaks can be frozen prior to shipment or stored at an American Red Cross facility. Certificates of Analysis can include sterility, viability, endotoxin, and immunophenotyping results, as well as any specified testing performed on the products. Additional documents can be provided upon your request.

• We offer RUO or GMP-compliant processing for raw material leukopaks, in either a cell therapy lab or cleanroom environment, for both minimal cell handling as well as processing and cryopreservation needs
• Cell therapy labs and clean rooms on-site – no travel or shipment delays between collection and initiation of processing
• Can accommodate manufacturing stage and need—from early stage development to later stage clinical manufacture and eventually commercial manufacturing
• On-site cryopreserved leukopak storage options at multiple locations