Florida-based Germfree presented its Mobile Adaptive Bioproduction Suite at the BIO International Convention in San Diego, US this week (June 19-22). The biopharmaceutical facility was highlighted at BIO 2017 as a featured tour on the exhibition floor.
The unit is the first of its kind to provide configurable space for biotech R&D and small-scale bioproduction within a self-contained mobile platform.
These suites provide cGMP-compliant biomanufacturing solutions by integrating cleanrooms and biocontainment zones in a 53 ft (16 m) trailer.
Previously, there were limited options for quickly addressing small-scale bioprocessing challenges. The Adaptive Suites deliver new options for fast, flexible and cost-effective production space that would be impractical in a brick and mortar building. Germfree's advanced platforms are engineered to operate as stand-alone facilities and can be easily repurposed and relocated globally.
The cleanroom trailer is a self-contained, stand-alone facility that can house a wide range of equipment for bioprocessing. This unit is configured as cGMP-compliant cleanroom for biotech R&D and small-batch production and can be set up for any required ISO grade and also provide biocontainment for pathogenic processes.
The units can be configured to meet the specific technical and validation requirements for each process.
In recent years, the number of new biotechnology startups has skyrocketed. However, many small-scale pharmaceutical projects lack the viable infrastructure to meet their demands.
Concurrently, there has been an industry-wide shift toward more flexible manufacturing environments. "The biotech industry is under intense pressure to adapt to production processes and facilities that keep up with the rapid pace of innovation," said Jeff Serle, Senior VP, Germfree.
"We've engineered the Mobile Adaptive Bioproduction Suite to provide the next level of flexibility that is key in the early stages of drug development.
“Germfree rapidly deploys turnkey facilities anywhere they are needed, for the duration of the project. Startups are able to begin R&D or early small-batch production without committing to traditional building construction or renovations which significantly reduces initial capital expenditures."
The Adaptive Mobile Suites are adaptable for emerging processes and all core equipment is interchangeable.
"Our mobile unit fits seamlessly at the intersection of emerging biotherapeutics, applications that require flexible space and new small-footprint bioprocessing equipment," says Carol Houts, Director of Quality, Germfree.
The suites are optimal for a wide range of biotechnology research, development and production applications including work with monoclonal antibodies, therapeutic proteins, gene therapy, viral vector, cell therapy and live virus vaccines.
Germfree manufactures advanced cGMP-compliant mobile and modular bioproduction and biocontainment platforms.