The human-derived haematological tissues and services specialist has built an ISO 7 cleanroom (with grade A and B zones)
AllCells, the specialist in the procurement and customisation of human-derived haematological tissues and services, has expanded its flagship processing facility in Alameda, California.
The expansion includes the addition of an ISO Class 7 cleanroom (with grade A and B zones), aimed specifically to support AllCells' growing GMP-compliant product portfolio.
The cleanroom is equipped with state-of-the-art instrumentation and employs a robust environmental monitoring (EM) programme to ensure control and compliance of the aseptic conditions during manufacturing operations. Located adjacent to one of three AllCells-Leukolab collection facilities, the cleanroom enables expanded technical capabilities to seamlessly process whole leukopaks for cryopreservation and/or subsequent cell isolation.
This cleanroom expansion complements AllCells' latest facility investments in California, Massachusetts, and Texas
The GMP processing facility is operated by a dedicated team under a robust quality framework, which includes operational oversight to ensure product quality, consistency and integrity.
"The expansion of the Alameda, CA processing facility is just another example of AllCells' investment and commitment to grow alongside industry demand and puts us in a great position to accommodate the production of GMP-compliant products for clinical applications." said Jay Tong, Founder and Chairman of AllCells.
This cleanroom expansion complements AllCells' latest facility investments in California, Massachusetts, and Texas aimed at meeting the growing requirements of the cell and gene therapy market.