Saturday, January 28, 2023

AllCells Announces New GMP Cleanroom

AllCells, the industry leader in the procurement and customization of human-derived hematological tissues and services, is pleased to announce the expansion of its flagship processing facility in Alameda, California. The expansion includes the addition of a class ISO 7 cleanroom (with grade A and B zones), aimed specifically to support AllCells’ growing GMP-compliant product portfolio.

Also Read: Novartis announces T-Charge, next-generation CAR-T platform with first-in-human data at ASH 2021

The cleanroom is equipped with state-of-the-art instrumentation and employs a robust environmental monitoring (EM) program 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.

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.” – Dr. 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.

About AllCells

Founded in 1998, AllCells is the global leader in the procurement and customization of biologically relevant research and GMP-compliant products and donor management services to support a diversity of life sciences applications. AllCells’ FDA-registered facilities, robust quality framework and proven industry expertise afford the responsiveness, product diversity, quality and regulatory standards required by researchers in life sciences. Our donor facilities – located in California, Massachusetts, and Texas – and GMP-compliant cleanroom are strategically located, enabling immediate processing and cryopreservation for unparalleled quality.

AllCells provides flexible and scalable solutions to support dynamic, client-specific needs and timelines from inception to commercialization. AllCells – Quality Cells for Quality Science

Subscribe Now

    Hot Topics