Genetic Engineering & Biotechnology News

NOV1 2018

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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GENengnews.com | Genetic Engineering & Biotechnology News | NOVEMBER 1, 2018 | 21 Pall and G-CON Collaborate on Viral Vector Production G-CON Manufacturing and Pall are collaborat- ing to bring turnkey continuous bioprocess or viral vector production facility solutions to the bioindustry. G-CON PODs will be customized with advanced Pall bioprocess equipment, in- cluding automation and utility supplies; these will be predesigned into the G-CON cleanroom units for scalable deployment. "Together, Pall's cutting-edge technology and G-CON's flexible cleanroom platform take the concept of modularity one step further, delivering a complete, reproducible, scalable facility solution that is easy to place or relocate, as well as clean, sanitize, and even repurpose," said Mario Philips, vice president and general manager at Pall Biotech. "This strategic collab- oration is particularly important to Pall, as we continuously improve bioprocesses for the in- dustry by offering innovative solutions like G- CON PODs customized with Pall technologies. This solution addresses customer demand for higher efficiencies, while enjoying more flex- ibility through scale-out and localization of manufacturing." PODs from G-CON are mobile and include integrated process piping and heating and air conditioning (HVAC) systems. Deploying the customized PODs allows a customer to focus on the target molecule, while relying on the G- CON and Pall teams to optimize the facility de- sign and process, said a G-CON spokesperson. "Once designed, the PODs ease verifica- tion, qualification, and validation challenges by providing comprehensive site acceptance testing and even IQ/OQ support. The PODs' flexibility allows them to support multiple products, and they can be easily repurposed. In addition, the cost of building a facility is drastically reduced, as is build time, which in- creases the return on investment," noted Maik Jornitz, president and CEO of G-CON. "G-CON's prefabricated cleanroom units feature a complete, yet compressed footprint for Pall's continuous bioprocessing and viral vector production designs. The implementa- tion of the Pall processes into our POD infra- structure creates an ideal turnkey solution for our customers. These solutions will be readily deployable and scalable, as they reduce the typical design, verification, and qualifica- tion efforts by standardizing processes and cleanroom environments," he continued. "We are looking forward to combining our PODs with Pall's process knowledge and designs to serve our joint customer base. The industry requires optimized, fast, scalable solutions, and these requirements will be met through this collaboration." Engineering teams from G-CON and Pall will align to design and deliver the mobile, pre- fabricated cleanroom units to meet individual customer needs. Process solutions will also be addressed in response to customer needs and applications. Both companies will continue to offer their products and services independent- ly, in addition to the collaboration. Sartorius Celebrates New Cell Culture Technology Center Sartorius Stedim Biotech held a topping-off ceremony for the new Cell Culture Technol- ogy Center at Science Park III that is located in the scientific hub of Ulm, Germany. This laboratory and office facility covering 6000 square meters will approximately double the space available so far at Sartorius' current site in Laupheim. With the building shell now completed, this investment of around €30 million ($34.79 million) has been progressing on schedule, ac- cording to a company official, who adds that relocation from the company's present site to Ulm is scheduled for the end of 2019. "This facility will be giving us new possibili- ties to meet the requirements of our custom- ers and to grow as a company in a promising market of the future," said Reinhard Vogt, ex- ecutive board member at Sartorius. As a partner of the biopharmaceutical in- dustry, the company in Laupheim has been developing cell lines and protein production processes, licensing technologies for manufac- turing proteins, and offering cell culture media and will continue to do so in the future at its new Cell Culture Technology Center. Sartorius acquired the Laupheim-based company Cellca in 2015, which had about 30 employees. Meanwhile, approximately 100 people work at this site. After its relocation, the company plans to increase its workforce in Ulm to more than 120. Pall, UCL Open CoE Pall has partnered with the University Col- lege London (UCL) Biochemical Engineering department to create the UCL-Pall Biotech Centre of Excellence (CoE) for research and training. The CoE will be operational from Septem- ber 2018 through 2024 with a management committee supported by UCL's strategic al- liance director, Naveraj Gill. The investment in the UCL Biochemical Engineering's indus- trial research collaboration program with Pall Biotech is valued at £2.7 million ($3.5 million) and is staffed by nine engineering doctorates and a fully funded postdoctoral research associate. The organizations will engage in multi-level interactions to enable knowledge transfer and address critical in- dustry challenges. "This alliance is another example of Pall Biotech's commitment to continuously im- prove bioprocesses through strategic part- nerships," said Mario Philips, vice president and general manager, Pall Biotech. "There is value that comes from working closely with partners—it allows our team to take a ho- listic approach to research that addresses core interests and industry challenges." The new CoE, added Gill, "will work to enhance drug production and empower the future workforce." n Bioprocessing News Bioprocessing The Premier Peer-Reviewed Journal on Gene Therapy Providing end-to-end coverage of the research, methods, and clinical developments driving today's explosion of gene therapy advances developments driving today's explosion of gene therapy advances Editor-in-Chief Terence R. Flotte, MD Deputy Editors, Europe Nathalie Cartier, MD Thierry VandenDriessche, PhD Deputy Editors, US Barry J. Byrne, MD, PhD Mark A. Kay, MD, PhD Human Gene Therapy Editor Guangping Gao, PhD Methods Editor Hildegard Büning, PhD Clinical Development Editor James M. Wilson, MD, PhD liebertpub.com/HGT Sign up for TOC alerts From chromatography skid to DSP skid for biologics From chromatography skid to DSP skid for biologics BioSC® Pilot, a new BioSystem for Chromatography: • Continuous and intensified process thanks to multi-step chaining • Product quality: automated and closed system to prevent contaminations and nonconformities • Highly flexible: configurable and modular to fit your downstream process BIOSC@NOVASEP.COM

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