AllCells Expands Its Clinical Grade Product Portfolio with GMP-compliant Cryopreserved Leukopak

ALAMEDA, Calif., Oct. 12, 2021 /PRNewswire/ -- AllCells, a leading global supplier for human-derived biological cells and tissues announced the launch of its new GMP-compliant cryopreserved leukopaks to address the growing industry need for high-quality starting materials. This addition expands AllCells' portfolio of GMP-compliant products and aims to provide researchers with the quality of fresh leukopaks with the benefit of extended shelf life and stability for reliable and flexible access to starting material for cell and gene therapy (CGT) workflows.

Leukapheresis products are enriched lymphocyte populations and the quality and functionality of these cells are key drivers of downstream manufacturing success. Cryopreservation of leukopaks at the peak of viability and functionality preserves the cells in their optimal state ensuring product quality and accessibility to donor material that meet customer specifications to mitigate the risk of costly donor scheduling delays or cancellations. Providing developers with scheduling flexibility without compromising product quality frees them to operate on their timelines, which can often be dynamic and changing.

GMP-compliant cryopreserved leukopaks are collected from qualified (per FDA 21 CFR 1271 guidelines) and IRB-consented, healthy donors at AllCells' FDA-registered and AABB-compliant collection facilities. Collected leukapheresis materials are immediately cryopreserved on-site within Class A and B (ISO 5 and 6) cleanroom environments using a proprietary, optimized and standardized process to assure high cell viability of lymphocyte populations with low-granulocyte contamination. AllCells' GMP-compliant products undergo extensive quality review to ensure adherence to quality standards and regulatory requirements. AllCells ensures product integrity with validated shipping containers for dependable cold chain logistics. Available formats include both client-customized products as well as an off-the-shelf version, the latter of which will be available before the end of 2021.

"The addition of GMP-compliant cryopreserved leukopaks strengthens our clinical product portfolio in support of our customers as they transition their therapies from research to commercialization. Accepting orders immediately, this new product provides flexibility, quality and consistency coupled with stringent regulatory standards that are needed in the industry," said Danny Zhang, CEO.

Click here to learn more about AllCells' GMP-compliant cryopreserved leukopak or contact us at [email protected] .

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About AllCells

Founded in 1998, AllCells is a global leader in the supply and customization of biologically relevant, high-quality research and clinical grade primary cells to support a wide scope of applications in life sciences and regenerative medicine from inception to commercialization. Our FDA-registered, IRB-approved donor collection and processing centers leverage the industry's largest repository of recallable, healthy donors with diverse demographics. Partner with us to achieve comprehensive solutions to meet program-specific needs on your timeline. The AllCells team, backed by years of scientific and regulatory expertise, is committed to delivering the highest quality cells quickly and reliably. AllCells – Quality Cells for Quality Science

Contact:
Valerie Goodwin
5107262700
[email protected]

SOURCE AllCells