GMP-compliant Fresh Leukopak
AllCells’ Clinical Grade Fresh Leukopak products are collected by apheresis from peripheral blood of healthy donors. Our Leukopaks contain a high concentration of lymphocyte populations, T Cells, B Cells, NK Cells, and monocytes. AllCells maintains on-site, FDA-registered donor centers for the collection of all products from IRB-consented healthy donors providing customers with a streamlined process for procuring clinical grade primary cells. A Certificate of Analysis (CoA) and summary of record are provided with every order. Clinical Grade Fresh Leukopaks are only available through consultation with an AllCells Made-to-Order representative.
- Diverse Donor Pool and Extensive Donor Screening
- High viability and stability leukopaks
- GMP-compliant qualification of SOPs and stringent quality systems
- Integrated Project Management approach to meet your specific criteria
Fresh Leukopak Made-to-order
AllCells' on-site GMP collection facility and GMP cleanroom enables us to offer the highest quality, made-to-order (MTO) custom products that will meet your specific needs – from specific donor attributes to cell isolation methods. The AllCells GMP team will partner with you, bringing project management expertise to define, design and deliver your donor program and product, all with regulatory oversight and following FDA guidelines.
We provide custom services at every level:
- Donor Management Services
- Cell Processing and Product Development
- Research-specific Isolation Protocols & Technology Transfers
GMP-compliant Leukapheresis Products are enriched in single-donor mononuclear cells (MNCs), allowing for scalability and reproducibility of experiments. Our products are quality controlled for cell count and viability using a validated AO/PI protocol and pass a Sterility Test in accordance with USP71 guidelines using compendial testing.
- Anti-coagulant: ACD-A
- Volume: NLT 280mL
- Viability: NLT 90%
- TNC Concentration (x106 cells/mL): NLT 26
- Sterility Test (USP71): No Growth
- Shipping: 2-8°C
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
- Overcoming the Global Biomaterial Supply Chain Challenge for the Development of CAR-T 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
- A Donor-Centric Approach to Cell and Gene Therapy