BioIVT And Germfree Launch State-of-the-Art Cleanroom in Winchester, VA

BioIVT, an international leader in biospecimen services and research support for drug and diagnostic development, has teamed up with Germfree, a pioneer in modular cleanroom infrastructure, to unveil a cutting-edge cleanroom manufacturing facility in Winchester, VA. This advanced cleanroom, designed by Germfree, aims to bolster BioIVT’s offerings for cell and gene therapy developers by providing essential GMP-compliant ancillary materials. Among BioIVT’s products are GMP-compliant raw materials for cell and gene therapy, such as Human AB serum.

Dr. Parijat Jain, Vice President of Cell & Gene Therapy at BioIVT, said in a statement, “This facility will play a significant role in our expanding portfolio of GMP-compliant products. The cleanroom was designed in collaboration with Germfree, relying on their extensive expertise to build a facility that will support client-specific manufacturing requirements and configured for high-volume production enabling product use in late-stage clinical and commercial manufacturing. We continue to evolve and strengthen our support for the development of CGT research, and our future-ready cleanroom will provide expanded capabilities and access to developers."

The newly constructed cleanroom manufacturing facility is specifically designed to enhance excipient and ancillary material bioprocessing workflows. Key features include compliance with FDA regulations, ISO 7 standards, FDA-cGMP guidelines, ISO and ISE standards, CDC-BMBL requirements, and ASTM testing. It is also equipped with advanced HVAC controls (BMS/EMS) systems and HEPA filtration.

Kevin Kyle, CEO at Germfree, "We at Germfree are honored to contribute to BioIVT's groundbreaking manufacturing space by providing our modular cleanroom technology. This new facility reflects BioIVT's dedication to advancing biospecimen solutions and scientific research, and the company's deep experience in helping manufacturers build cutting-edge facilities. We are excited to support their mission and look forward to the innovative achievements that will benefit the life sciences and pharmaceutical industries, fostering advancements in research and development.”