NEWS RELEASE: BioIVT and Germfree Announce New Cleanroom Manufacturing Space in Winchester, Virginia
The cleanroom spotlights BioIVT’s expanded capabilities enabled by Germfree’s technology to further support and strengthen the development of cell and gene therapies (CGT)
WESTBURY, N.Y. — BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced in partnership with Germfree, a leading innovator in modular cleanroom infrastructure and services, the opening of its new cleanroom manufacturing space in Winchester, Virginia. The state-of-the-art cleanroom leverages design and solutions from Germfree to further establish BioIVT as an industry leader providing cell and gene therapy developers uncompromised access to critical GMP-compliant ancillary materials. BioIVT’s GMP-compliant cell and gene therapy supporting raw materials, including Human AB serum, will gain immediate benefits with the integration of industry leading cleanroom processes.
“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. Ensuring the highest level of quality and regulatory compliance, the cleanroom boasts the following features:
- Qualified in accordance with FDA requirements
- ISO 7
- FDA-cGMP, ISO, ISE, CDC-BMBL and ASTM tested
- HVAC controls (BMS/EMS) systems
- 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.”
The cleanroom officially opens on Aug. 1, 2024, in Winchester, Virginia. Please visit BioIVT’s website to learn more about their work with CGT, and Germfree’s website for more on their modular CGT cleanroom capabilities.
About BioIVT
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®. For more information, please visit www.bioivt.com or follow us on LinkedIn.
About Germfree
Germfree is a global leader in the design, manufacture, and maintenance of modular cleanroom environments. With decades of global expertise in serving the biopharmaceutical industry, Germfree specializes in providing advanced solutions that enhance the safety, efficiency, and sustainability of critical healthcare manufacturing processes. Germfree is continuing to invest in cleanroom design and manufacturing solutions and is committed to providing innovative solutions, with the goal of improving patient access to critical medicines. Germfree is backed by the healthcare growth equity investor, EW Healthcare Partners. www.germfree.com
The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
