BioIVT, a biospecimen solutions provider for drug and diagnostic development, announced the completion of its new cleanroom manufacturing space in Winchester, Virginia, built in collaboration with modular cleanroom infrastructure and services provider Germfree.

The cleanroom enhances BioIVT's capabilities and strengthens the company’s development of cell and gene therapies (CGT) raw materials, including Human AB serum.

“This facility will play a significant role in our expanding portfolio of GMP-compliant products," said Parijat Jain, vice president of CGT at BioIVT. He said that the collaborative cleanroom design relies on Germfree’s extensive expertise that enables the two companies “to build a facility that will support client-specific manufacturing requirements." He said the facility is "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 will support excipient and ancillary material bioprocessing workflows. The cleanroom is qualified in accordance with US Food and Drug Administration (FDA) requirements and has received ISO-7 cleanroom classification.

A representative for BioIVT told BioProcess Insider that the company entered its partnership with Germfree in October 2021. Installation and site preparation began in Q1 2024 and was completed on August 1, 2024. The company invested $1.5 million in the new cleanroom and related upgrades.

“The facility is an ISO-7, 12 by 50-foot modular unit with unidirectional flow, integrated heating, ventilation, and air conditioning (HVAC), and three active pass-through windows for optimal material handling,” the spokesperson said. “The unit includes designated rooms for gowning, biological processing, and sterile filtration, all accessed through zero-contact wave-to-open doorways.”

Although BioIVT has performed cleanroom manufacturing at its Winchester site for many years, the new facility has significantly increased capacity and has 21 CFR Part 11 compliant monitoring of temperature, humidity, and differential pressure for CGT products. 

The spokesperson said, “Germfree and BioIVT's have partnered to perform stringent commissioning, qualification, and validation testing and will continue to engage on training and maintenance of our cleanroom to ensure the highest quality standards.”