Flexible biopharma trailers are ready for sudden capacity needs.
Germfree introduced its Adaptive BioPharma Production Suite at Interphex 2017. The company’s self-contained BioPharma Trailers are designed to be deployed for a wide range of applications when a dedicated, limited-scale cGMP-compliant facility is required. The innovative platform offers mobile, flexible cleanroom space and is configured to meet required ISO grades and biological safety levels up to BSL-3.
Germfree designs, which engineers and manufactures transportable production units to deliver rapid and flexible solutions, designed its trailers to deliver advanced capabilities when existing infrastructure is insufficient or unavailable. With extensive global experience in manufacturing transportable cleanrooms and labs, the company says its biocontainment and cGMP expertise has positioned Germfree to be a leader developing advanced mobile facilities with complex controlled environments.
According to Germfree, the biopharmaceutical industry is quickly implementing new technologies and platforms to help broaden the pipeline for emerging therapies. “There is a call for specialized and flexible cGMP-compliant space,” said Germfree, “Many applications simply require small-scale, preclinical process areas and cleanrooms. Separate, short-term facilities are often ideally suited for the early stages of drug development. For startups, these units can be repurposed as production is ramped up to later phases.”
Germfree’s BioPharma Trailers, said the company, are suitable for a wide range of applications including small-batch biologicals, developmental vaccines, R&D batches, Phase I and Phase II clinical trials, cell therapy, gene therapy and other developmental stages of biotechnology. The company also said the mobile units can be instrumental in maintaining the cold chain and create environments suitable for staging or storing fragile therapeutics. The mobile units are also suitable for handling potent APIs or similar hazardous biological agents. The design integrates all primary and secondary containment systems and the mobility and modularity of the units means drug processors can segregate and isolate pathogenic agents from other buildings and operating personnel.
Featuring fully integrated engineering controls, all HVAC, air filtration and containment systems are configured during fabrication. Germfree notes that the company's extensive experience manufacturing mobile cleanrooms and laboratories assures the unit’s environmental controls meet critical demands. Germfree also integrates all core containment and equipment including RABS and isolators, Class III biological safety cabinets, Class II BCSs, laminar flow workstations, powder containment enclosures and fume hoods.
Germfree products are manufactured in an environmentally controlled factory and, according to the company, the units offer users a cost-efficient rapid-response approach to handling capacity constraints, from product demand response to epidemic readiness or as a convenient, cost effective way to add new aseptic processing capability or containment. Similarly, Germfree units can be installed within ongoing operations or repurposed for biopharmaceutical process change-outs.
