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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6 | NOVEMBER 15, 2017 | | Genetic Engineering & Biotechnology News Gail Dutton A small biotechnology company was ready to move its vaccine from the laboratory to clinical trials. Even though the company lacked its own manufacturing facilities, it wasn't ready to put its fate into the hands of a third party. The company's solution? Buying a mobile adaptive laboratory from Germfree Laboratories. "Since then, that company has completed Phase I and is planning Phase II," says Jeff Ser- le, senior vice president and general manager of Germfree. "It plans to keep the trailer." Germfree is known for mobile laborato- ries, which can provide "as needed" access to laboratory facilities, as well as for modular laboratories, which can allow conventional buildings to incorporate customized sterile laboratories quickly, within months, without the cost of rebuilding. Both the mobile and the modular options have the virtue of speed, which is appropriate, given that Germfree is headquartered in Ormond Beach, FL, the city that became known as the "Birthplace of Speed" because it hosted some of earliest timed automobile races in America. A History of Containment When Germfree began 55 years ago, it manufactured isolators for sterility testing and biosafety cabinets for hospital pharma- cies. It expanded to customized containment equipment in the late 1980s, working with the U.S. military to design laboratories that were dropped by parachute into remote loca- tions. In the early 2000s, as the need for con- tainment and complexity increased, the com- pany developed mobile BSL-3 laboratories. As Germfree adapted its business model, the company climbed a steep learning curve and solved myriad problems through trial and error. "We knew that all the controls, security, fire protection, and CCTV moni- toring used in a brick-and-mortar building had to be integrated into a mobile labora- tory or module," notes Serle. "So, we in- creased our engineering staff." New ISO high cube refrigerated ship- ping containers provide Germfree with the building blocks for its laboratories. "Every country can receive these," Serle points out. Germfree's mobile laboratories have been shipped to Singapore, Saudi Arabia, and Senegal (where the company has offices), as well as to Nigeria and other nations. Germfree's history with hospital pharma- cies and military laboratory biocontainment facilities served the company well, easing its transition to biotech laboratories. The compa- ny's modular and mobile approach to biotech laboratories proved to be advantageous when cGMP standards became more rigorous. To illustrate how cGMP standards re- late to Germfree's fortunes, Serle cites the company's work with a drug manufacturer: "The laboratory space for clinical trials was housed in an aging, multistory building that couldn't meet the more rigorous cGMP stan- dards. Rather than demolishing the building, the client ordered a modular laboratory." After the new laboratory is tested in Germ- free's factory and is fully functional, it will be disassembled and moved to the site for installation and validation. While buying mobile or modular labora- tories is less costly than building new facili- ties, the real benefit is knowing the labora- tory will go online on time and on budget, Serle tells GEN. "How many construction projects do that?" he asks. The difference between building a labora- tory and buying a mobile or modular labora- tory is that the latter are products. They have a firm fixed price and undergo installation qualification (IQ) and operation qualifica- tion (OQ) testing. Once delivered, they can be fully functional in a few weeks to a few months, depending on where in the world they are delivered. Building a laboratory, in contrast, requires months to years. An Unexpected Difference Nearly one third of INTERPHEX 2017 attendees walked through a Germfree mobile laboratory last spring, Serle recalls. "What surprised people is that in many cases, our mobile laboratory was nicer than the labora- tories that they had used," he says. "And our laboratories aren't hard to certify." "Mobile laboratories aren't like mobile homes or the portable buildings erected at schools," Serle continues. "This is a custom laboratory built on a semi-trailer platform. It's metal. There's no wood. The interiors are smooth and seamless." Serle says Germfree's mobile work for the military was instructive: "We learned what works in terms of designs and products. In the early days, durability was an issue. A Germfree Can Provide Remote or Contingent Laboratory Space, or Enhance Existing Facilities Mobile and Modular Labs Offer Control and Speed Corporate Profile Germfree Laboratories' BioPharma Trailers can be deployed for a range of applications where a dedicated or limited-scale cGMP-compliant facility is required. This image, an interior view, suggests how a mobile laboratory may provide cleanroom process areas as well as any needed containment. Insights Industry Watch As Gilead Sciences' Kite subsidiary won FDA approval for Yescarta™ (axicabtagene ciloleucel)—the agency's second for a cancer-fighting chimeric antigen receptor T-cell (CAR-T) treatment. Researchers welcomed the news. "This is the beginning of a new era of cancer therapy," declared Armin Ghobadi, M.D., an oncologist at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, in a statement. As with the first-approved CAR-T therapy, Novartis' Kymriah (tisagenlecleucel), the FDA acted well ahead of schedule. The agency had set a Prescription Drug User Fee Act target decision date for Yescarta of November 29, 2017. Yescarta's October 18 approval came 15 days after Gilead completed its approximately $11.9 billion acquisition of Kite (formerly Kite Pharma). "By 2025, there will be many approved T-cell therapies for a variety of cancers," predicted David Maloney, M.D., Ph.D., medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center and medical direc- tor of the Bezos Family Immunotherapy Clinic. "The FDA's ruling validates the revolution underway in the field of cellular immunotherapy." Dr. Maloney said researchers still need to learn why they work in some cancers for some people, and can cause severe, occasionally fatal, side effects in others. At a list price of $373,000, Yescarta costs 21% less than Kymriah, which is priced at $475,000. Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. The approval follows the ZUMA-1 pivotal trial, in which 72% of the 101 patients treated with a single infusion showed an objective response rate, with 51% showing complete remission. However, Yescarta will be sold with a Boxed Warning, as 13% of ZUMA-1 patients experienced grade 3 or higher cytokine release syndrome, and 31% experienced neurologic toxicities. n Researchers See New Era as FDA OKs Kite CAR-T Therapy Yescarta Germfree designs, engineers, and manufactures transportable pro- duction units to deliver rapid and flexible solutions. These units may provide separate, short-term facilities, which are often suitable for small- batch applications and the early stages of drug development.

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