BioIVT, a global research partner and biospecimen services provider for drug and diagnostic development, in partnership with Germfree, an innovator in modular cleanroom infrastructure and services, opened its new cleanroom manufacturing space in Winchester, VA. The state-of-the-art cleanroom leverages design and solutions from Germfree to enhance BioIVT’s services for cell and gene therapy developers providing access to critical GMP-compliant ancillary materials. BioIVT offers GMP-compliant cell and gene therapy supporting raw materials, including Human AB serum.
 
“This facility will play a significant role in our expanding portfolio of GMP-compliant products,” said Dr. Parijat Jain, Vice President of Cell & Gene Therapy at BioIVT. “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 new cleanroom manufacturing space is purpose built to support excipient and ancillary material bio processing workflows. Features include: Qualified in accordance with FDA requirements, ISO 7, FDA-cGMP, ISO, ISE, CDC-BMBL and ASTM tested, HVAC controls (BMS/EMS) systems, and HEPA filtration.
 
“We at Germfree are honored to contribute to BioIVT’s groundbreaking manufacturing space by providing our modular cleanroom technology,” said Kevin Kyle, CEO at Germfree. “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.”