Genetic Engineering & Biotechnology News

NOV15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | GENengnews.com | NOVEMBER 15, 2017 | 7 laboratory would end up with a crack in the wall or wouldn't be airtight after delivery." Those problems caused Germfree to develop a continuous improvement program that fo- cuses on known problems during the design, implementation, and testing of each unit "to ensure they didn't happen again." Germ- free also established a mentor program. Lessons learned from those days include using 40 × 12-foot sheets of high-perfor- mance polymer to minimize seams and en- hance cleanability, and merging the floor into the wall. Gang boxes (the boxes behind walls that house electrical outlets and switches) are designed to prevent air leakage and are he- lium-tested. As a result, Germfree's contain- ment units pass the required pressure tests. Founded by a physician intent on elimi- nating surgical infections, the company has a heritage in environmental control. Today, the company's reputation depends on its abil- ity to construct controlled environments. Serle himself is the past president of the Controlled Environment Testing Association, and other staffers are active in the International Society for Pharmaceutical Engineering. Many staffers have first-hand expertise in regulatory affairs. Biopharma's Special Needs Germfree is especially focused on the bio- pharmaceutical industry and plans to intro- duce several products for this industry in the coming year. "There's a lot of need among biopharma customers…those with one or two projects, those with researchers coming out of graduate school, and large companies needing more flexibility," Serle asserts. Mo- bile laboratories and modular buildings, he stresses, provide the quick access that startup companies need, and help larger organiza- tions minimize risk by segregating upstream work from sterile manufacturing space. Getting started is merely a matter of de- ciding what you want in a mobile labora- tory or modular space. Germfree delivers the building with already-installed generic labo- ratory equipment—refrigerators, freezers, and incubators, for instance. Customers set up their laboratories with their own analyti- cal and benchtop equipment, and perform the process qualification to ensure their pro- cess works in the space. "Every setup is different, and they all have challenges," Serle points out. Setup variables include process requirements, the number of people that will use the space, the tasks to be accomplished in-house (or outsourced), and the extent to which laboratory staff will re- quire additional support. This is particularly important for laboratories on the far reaches of campuses or in remote locations. Mobile laboratories and modular facilities aren't the right answer for every company, of course. Large manufacturing needs still are best met with brick-and-mortar buildings. Companies with smaller laboratory or manu- facturing needs, however, may benefit. Mo- bile laboratories offer about 420 square feet, whereas modular buildings can be connected for up to 15,000 square feet of laboratory or manufacturing space. Looking toward the future, Serle says, "Germfree would like to be more involved in biotech incubators and university laborato- ries, providing spaces that can be reconfigured easily as needs change." Disposable manu- facturing also offers opportunities. "Ninety percent of the products we're supplying are designed around disposable manufacturing," Serle notes. "It's the way of the future. www.mirusbio.com ©2017 All rights reserved Mirus Bio LLC. Mirus Bio is a registered trademarks of Mirus Bio LLC. All trademarks are the property of their respective owners. At Mirus, our role in PROGRAMMING THE GENOME gives scientists the tools to ADD, DELETE or MODIFY any gene at will. We accomplish this through support of ANY delivery method capable of delivery of ANY nucleic acid into ANY cell type . Whether there is a need for high functional virus titers, or efficient knockdown of target genes, or effective, low toxicity solutions, our delivery systems for molecular and cell biology applications give researchers unprecedented genome control at their fingertips. Visit www.mirusbio.com and explore the tools for unprecedented genome control AND request a sample of any of the TransIT ® Transfection Reagents. Corporate Profile Germfree Laboratories Location Four Sunshine Blvd. Ormond Beach, FL 32174 Phone (386) 265-4300 Website www.germfree.com Principal Kevin Kyle President Number of Employees 90 Focus Germfree Laboratories manufactures mobile laboratories and modular laboratory and manufacturing space specifically designed for the biopharmaceutical industry and for hospital pharmacies. Vital Signs

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