A first of its kind, mobile platform for advanced therapeutic medicinal products was introduced this week by Germfree Labs, a Florida company, at Advanced Therapies Week in Miami Beach. The new bioGO® cGMP Mobile Cleanroom solves complex logistical challenges facing the CGT (cell and gene therapy) industry. The flexible bioprocessing platform was designed by Germfree in response to critical constraints in the development, manufacturing and delivery of new and emerging curative therapies.
Germfree’s biomanufacturing platform addresses current industry needs, while de-risking and future-proofing for a rapidly evolving industry. “The industry is delivering on the promise of cell and gene therapeutics with rapid development and growth. New patient care requirements are a key consideration, adding a sense of urgency. The precise timing and logistics of collecting a patients cells may not work in a centralized model. Our mobile platform supports decentralized models, which will also allow the industry to democratize these therapies globally” said Carol Houts, VP of Business Development.
“The bioGO mobile platform supports the scale-out process by using standard, proven cGMP facility designs that are pre-commissioned and pre-qualified, significantly shortening the time to process readiness. Process spaces can also be reconfigured or interconnected to add bioGO units, for a larger facility. We are delivering fast, flexible and cost-effective infrastructure, previously not available,” said Kevin Kyle, CEO of Germfree.
The extremely high cost of clinical trials, was also a consideration when rolling out bioGO. The adaptive infrastructure and financial model can promote development by reducing early financial obstacles. Fast, flexible space allows clinical trials to start when needed. A trial can become operational, pivot or scale without traditional capital building expenditures.
“We looked at the main drivers that are important to our clients and patients. Germfree’s bioGO Mobile Cleanrooms will be an impactful solution in overcoming many of the challenges the industry is facing,” said Kevin Kyle.
About Germfree: Germfree Laboratories Inc. creates environments that serve life science innovation and advance global health. The company, founded in 1962, designs, engineers, and manufactures flexible cGMP-compliant cleanroom facilities and mobile units, as well as high containment laboratories, which are process-ready, upon deployment.