BioIVT, the drug and diagnostic development expert, has teamed with Germfree for its new cleanroom manufacturing space in the US.
The new modular facility opened in August.
Kevin Kyle, CEO at Germfree, said: “We at Germfree are honoured to contribute to BioIVT's groundbreaking manufacturing space by providing our modular cleanroom technology."
The state-of-the-art cleanroom leverages design and solutions from Germfree, a US-based laboratory and cleanroom manufacturing company, to further establish BioIVT as an industry leader, providing cell and gene therapy developers 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.
The new cleanroom manufacturing space is purpose-built to support excipient and ancillary material bio-processing workflows.
Dr Parijat Jain, VP of Cell & Gene Therapy at BioIVT, said: “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,” Jain concluded.
The new cleanroom manufacturing space is purpose-built to support excipient and ancillary material bio-processing workflows.
BioIVT's GMP-compliant cell and gene therapy supporting raw materials, including Human AB serum
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
CEO Kyle said: "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,” Kyle concluded.
