GMP-compliant Mobilized Leukopak
AllCells’ Clinical Grade Mobilized leukopaks are apheresis products collected from healthy donors treated with FDA-approved drugs to stimulate mobilization of CD34+ hematopoietic stem and progenitor cells from the bone marrow to the peripheral blood. This procedure results in large-scale yields of CD34+ cells. Peripheral blood is collected from IRB-consented donors using the continuous flow Spectra Optia® Apheresis System directly into ACD-A anticoagulant at AllCells’ FDA-registered, IRB-approved collection facilities.
Regimen details: Reg H = Filgrastim (Neupogen®) 10ug/kg/day x 5 days + Plerixafor (Mozobil®) 240ug/kg/day x 2 days on day 4 and 5 (evenings), apheresis on day 5 and 6.
Disclaimer: This product is available for further manipulation, not intended for human use. AllCells is in the process of obtaining FDA approval to use this product for further manipulation for the purpose of manufacturing treatment and/or drugs intended for human use.
Donor Management Services
Donors with the right attributes are a critical part of any cell therapy program. AllCells Donor Management Services can help you find, screen and retain donors from our repository comprised of highly-characterized, HLA-typed donors with diverse demographics and clinical parameters that can meet program-specific criteria from research and development to commercialization.
Learn MoreGMP-compliant Mobilized Leukopak Products are enriched in CD34+, allowing for scalability and reproducibility. The product is quality controlled for viability using a validated AO/PI protocol and pass a Sterility Test in accordance with USP71 guidelines using compendial testing.
- Format: Fresh, 2 Paks
- Anti-coagulant: ACD-A
- Viability: NLT 90%
- Fill Volume: NLT 280mL
- Cell Concentration: FIO
- Sterility USP <71>: No growth
- Expiration: 4 days post collection
- Shipment at 2-8C with temperature logger
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At AllCells, we believe that your success is our success. We believe that sharing our knowledge and expertise is more than a business practice, it’s a responsibility. And we believe that collaboration leads to better outcomes. Below is a collection of relevant links to Leukopak resouces including blog posts, webinars and useful protocols to help you become more efficient and more effective. Have technical questions about Leukopak products? Our Customer Success Team is standing by.
WEBINARS
BLOG POSTS
- Navigating the complex world of regulations: How AllCells is changing cell therapy and protecting against product-ending events
- The Key to Developing Good Manufacturing Practice (GMP) Biomaterials for Cell and Gene Therapy Development
- Dual Mobilization Enhances CD34+ Yield Across All Donor Types
- The Therapeutic Potential of HSC-based Gene Therapies
- Why You Should Start Clinical Grade Cell Supply Discussions Early in Cell and Gene Therapy Development
- What You Need to Know About Regenerative Medicine in 2022: Industry and Tech Trends