Collected from qualified healthy donors that meet baseline FDA 21 CFR 1271 requirements, industry’s first In Stock GMP Cryopreserved Leukopaks significantly decrease lead time
AllCells, the industry leader in the procurement and customization of human-derived hematological tissues and services, is pleased to announce the launch of its In Stock GMP Cryopreserved Leukopaks. While donor customizations are often required for immunotherapy programs, many operations in late-stage clinical phases are supported by GMP Leukopaks collected from qualified healthy donors that meet baseline FDA 21 CFR 1271 requirements. Reducing clinical grade product lead time affords researchers a higher degree of flexibility and improved access to high-quality starting material to readily respond to changes and meet condensed timelines. This industry first off-the-shelf offering is one of many new GMP solutions that AllCells is providing to meet the growing and rapidly evolving needs of the cell and gene therapy market.
GMP Leukopak collections from validated donors occur at AllCells-Leukolab centers and are immediately transferred to adjacent FDA-approved processing facilities for cryopreservation using industry best practices and state-of-the-art equipment in cleanroom environments. The GMP processing facility is operated by a dedicated team under a robust quality framework and operational oversight that, along with an environmental monitoring program, ensures stringent control and compliance of the aseptic conditions during manufacturing operations to safeguard product quality, consistency and integrity.
“The continued advancement and diversification of our clinical grade portfolio is a top mandate at AllCells for 2022 and beyond,” said Danny Zheng, CEO. “This new In Stock GMP Leukopak offering sets AllCells apart in the industry and gives customers access to off-the-shelf, ready-to-ship clinical grade material with shortened lead times – keeping pace with rapid innovations in this age of genomic medicine.”
