Cell and Gene Therapy Solutions

Cellular raw materials are an important determinant of effective cell therapy technology development and an especially key factor for clinical translation and the manufacturing scale-up of cell therapies. The Red Cross can streamline cell and gene therapy development through refined donor selection, cGMP production capabilities and standardized quality management approach.

The Red Cross is your partner in identifying donor selection criteria upfront that yield consistent, high quality starting materials to support successful process development, clinical manufacturing, and eventual commercialization of your unique cell therapies. We make available standard resources such as donor samples paired with pre- and post-collection donor questionnaires to enable valuable donor selection early on in your key raw materials sourcing, thereby driving efficiency in your processes.

Cell handling, processing and cryopreservation of raw materials, when necessary, are critical to the successful development and manufacturing of cell therapies. The Red Cross furthers our commitment to providing high-quality starting materials by offering GMP grade production of our processed, cryopreserved raw materials for use in the research and development stage through clinical trials and eventual commercial manufacturing of your advanced therapies.

By operating under a single Quality Management System and utilizing standard apheresis collection procedures, the Red Cross further limits the variability in starting materials and ensures consistency and reliability throughout our network.

The Red Cross makes available standard enhancement options to custom design a cell and gene therapy solution to meet current and future development needs. Our clients can elect to use these individually or in combination to tailor a solution specific to their requirements.

Donor Selection

• Whole Blood Samples
• Client-specific Donor Questionnaires
• Client-specific Advance Pre-screen 
• Donor Attribute Management 
• Donor Characterization

Apheresis Collections Procedures

• Collections Equipment Selection
• Total Blood Volume to Be Processed 
• Target Volume of Final Product
• Target Cells to be Collected
• Addition of Autologous Plasma

Product Characterization and Testing

• Cell Viability
• Total Nucleated Cell Count (TNC) 
• Total Cell Count (TCC)
• Product CBC 
• Product Hematocrit 
• Product Sterility 
• Endotoxin 
• Mycoplasma
• Immunophenotyping 

Cell Handling, Processing and Shipping

• Identification of Specific Cell Types and Populations
• Immune Cell Enrichment 
• Irradiated Feeder Cells
• Supplier/Equipment Selection
  
• Cellular Therapy Lab or Cleanroom
• Custom Product Aliquoting 
• Custom Product Shipment

With more than 60 active apheresis collection sites nationwide and an additional 500 facilities across the country, the Red Cross is the largest single provider of apheresis collections for cellular therapy, performing thousands of collections on both the Spectra Optia and Fresenius Kabi Amicus devices. Our footprint allows us to rapidly scale and expand collections activities to meet your growing needs. This broad network allows us to reduce the time between donor collection and delivery of fresh product, or initiation of RUO or cGMP processing and cryopreservation in our in-house labs or clean rooms, depending on your processing requirements.

The Red Cross maintains a robust and diverse IRB-consented donor pool across the country, with strong recallability to support your cell sourcing needs and ensure they can be met consistently and reliably every time. Our extensive experience in donor recruitment and donor management ensures the Red Cross’s ability to identify and select donors who are best suited to meet your specific development needs. We can accommodate requests for donor selection on lifestyle and specific demographics such as BMI, ethnicity, age, and gender. Additionally, our broad donor testing capabilities (CMV, EBV, HLA typing and KIR testing) can further refine your donor selection criteria.

A strong, standardized quality approach and management system is crucial to limiting variability in starting materials and ensuring a high-quality product. All our apheresis collection sites operate under a national Quality Management System (QMS) and a standard set of procedures. In addition to delivering consistent practice and products, our QMS allows a single systemwide audit with local audits focused on the review of individual-site items, such as local staff training and equipment records to provide for a more streamlined audit process for our clients.

Each Red Cross client is supported through a centralized account management team led by a technical lead to serve as a single point of contact for all client engagement ranging from donor selection and collections to processing and storage. Experienced in both onboarding new clients in early product development and partnering with clients as they advance their cell therapies to commercialization, your account manager provides ongoing technical expertise at every stage of the process. Based on knowledge and practice, your technical lead can guide adjustments and optimization throughout and program oversight to ensure our services meet your current and evolving cell and gene therapy needs.