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Pharmaceutical Technology BUYERS' GUIDE 2020 125 INNOVATION OUTLOOK THOUGHT LEADER SLONME - STOCK.ADOBE.COM S P O N S O R E D C O N T E N T Steve Nole Vice President, Operations Grand River Aseptic Manufacturing INVESTING IN TECHNOLOGY TO REDUCE HUMAN INTERVENTIONS Emerging technology innovations in the CDMO industry are focused on automation and advanced manufacturing practices to reduce human interventions. Modern isolator technology is a key trend for increased safety and quality. Isolators allow companies to achieve a higher sterility assurance level (SAL), operate in a Grade C space, and recognize lower operating expenses due to a smaller cleanroom and fewer gowning requirements. Isolator technology can use a combination of dedicated parts that are autoclaved and transferred into the isolator via rapid-transfer canisters, or preassembled and gamma-irradiated assemblies in bag-in-bag-out with rapid-transfer ports. This flexibility allows the CDMO to assemble and sterilize their own assemblies or source preassembled material from a third party. These benefits do come at a cost, as isolator technology tends to have a higher initial investment for equipment costs. To increase capacity and maintain our quality track record, Grand River Aseptic Manufacturing (GRAM) chose to invest in isolator technology for our recently completed large-scale fill and finish facility. GRAM's opportunity to expand led to a design build facility that includes a Bausch+Ströbel fully integrated high-speed filling line with SKAN isolator and IMA LyoMax 17 lyophilizer. This state-of-the-art equipment resulted in a robust and modern system. Innovations in technology that reduces human intervention will continue to be a focus; however, it is critical to not lose sight of the staff that manages this equipment. Alongside innovative equipment and technology, CDMOs should hire people who are agile, enjoy continuous learning, and are accountable for themselves and their work. Team members should receive in-depth training and have the skills to adapt in real time if issues arise. Investing in the best equipment will only produce success if human knowledge and experience guide decision-making. Flexibility and modernization allow GRAM to service multiple customers from biologics, small molecule, suspension products, aseptic formulations, lyophilized and liquid products in vials or syringes. Modern facilities, equipment, and technology help to align with regulatory requirements and reduce human interventions to keep quality the priority. ABOUT STEVE NOLE Responsible for manufacturing and packaging operations and facility engineering, Steve Nole has more than 18 years of industry experience with biologics and small-molecule aseptic manufacturing, lyophilization, technical transfer, new facility startup, and contract manufacturing organization management. ABOUT GRAND RIVER ASEPTIC MANUFACTURING Grand River Aseptic Manufacturing, Inc. ("GRAM"), a parenteral contract development and manufacturing organization, delivers customized solutions to meet clients' fill and finish needs from development through commercialization. GRAND RIVER ASEPTIC MANUFACTURING, INC Company Name : Grand River Aseptic Manufacturing Phone : 616.678.2400 Email : info@grandriverasepticmfg.com Website : www.grandriverasepticmfg.com