Leukopaks® as Starting Materials: Discovery to Commercialization
About Versiti Leukopaks
Versiti leukopaks (apheresis mononuclear cells) are enriched leukapheresis products composed of high concentrations of monocytes and lymphocytes, but may also contain lower concentrations of platelets, plasma and red cells. Versiti leukopak products are available for both research use only (RUO) and clinical-grade applications (FDA 21 CFR 1271 compliant). Products collected from healthy donors include screening and characterization to meet unique project needs.
Versiti Leukopaks are available for both research-use only and clinical-grade applications.
Versiti Leukopaks
| Expected total nucleated cell (TNC) count | 10-12 billion cells (full collection) Product TNC yield may vary depending on individual contributors. Other cell counts available based on study needs. |
| Standard blood volume processed | Versiti’s IRB- approved protocol allows for up to two blood volumes from a healthy contributor. |
| Donor characterization | 100% HLA typed by NGS characterization: HLA Class I - A, B, C and Class II - DRB1/3/4/5, DQA1, DQB1, DPA1 and DPB1. ABO and RH type. Other characterizations available upon request. |
| Infectious disease testing | CMV antibody, hepatitis B surface antigen, hepatitis C core antibody, hepatitis C virus antibody, HIV antibody, Trypanosoma cruzi antibody (Chagas disease), West Nile virus (WNV). Expanded infectious disease testing available to meet your protocol needs. |
| Collection method | Leukopaks are collected at Versiti’s FDA-registered collection center from IRB-consented, healthy human donors by leukapheresis using the Spectra Optia apheresis system continuous mononuclear (CMNC) collection procedure in ACD-A anticoagulant. |
| Collection quality assurance | Products are collected following formal quality systems that result in reduced variability and risk. Every clinical-grade product release is subject to review by an independent quality assurance representative and approval of the batch record. Certificate of analysis (COA) is provided with each product. COAs may be customized according to project needs. |
| Preservation and delivery | Fresh: Products are shipped same day with overnight delivery or same-day delivery in the Austin, TX, area. Cryopreserved: We can freeze to project specifications. We ship via dry ice or dry shipper. |
Leukopaks as a Starting Material for Manufacturing
Versiti looks forward to partnering with you to support your research, development and/or commercial manufacturing processes. Learn more about our leukopak process.
Initial consultation
- Through our consultative approach, we help you determine the optimal blood products needed for your stage of development.
- Versiti seeks to de-risk your manufacturing process by providing RUO and GTP-compliant starting materials fully customizable to your requirements.
Order placed
- After your initial consultation, contract execution, project setup and quality review are complete, the process to obtain your customized product begins.
Matching contributors identified (1-3 days)
- Versiti’s well-characterized, recallable donor base operates under an IRB-approved protocol. All donors are characterized by HLA, ABO type and infectious disease, including CMV status
Contributor screening and selection ( ̴1 week)
- Eligible contributors undergo a general health assessment in accordance with FDA requirements to determine final eligibility.
- Based upon project scope and donation frequency, we select final contributors.
- Custom biomarker screening is available.
Collection and shipment (1-2 weeks)
- We collect samples at our FDA-registered collection center from IRB-consented, healthy human donors. Versiti’s vertically integrated services optimize product testing and logistics. Versiti provides a certificate of analysis (COA) and independent review of every product.
Filling Leukopak Gap
With significant projected growth of cellular therapies, several limiting factors, including the high cost of leukapheresis and stringent donor recruitment criteria for leukopak collections, pose a unique set of challenges for companies without significant experience in the space.
Selecting the Right Biomaterial Product: Regulatory Considerations and Terminology
Navigating the regulatory and compliance guidelines for source materials like leukopaks or other human blood products for the emerging cell therapy market involves having a clear understanding of your research goals. Download Versiti’s whitepaper discussing regulatory considerations in selecting the right biomaterial product.
Customized Starting Materials for Manufacturing Client Highlight
In this case highlight, learn more about how Versiti’s consultative approach and partnership with a client established a process for a recallable and usable contributor bank to provide quality starting materials for manufacturing in this case highlight.