Leukopaks® as Starting Materials: Discovery to Commercialization

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 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.