Roche presents on the role of robotics in their manufacturing strategy
On November 6, Mr. Markus Stübchen, Roche’s Global Technical Lead for Large Molecule Drug Product & Clean Utilities, delivered the presentation Novel Approaches for Robotics Use in Sterile Manufacturing. The presentation was given at the American Association of Pharmaceutical Scientists (AAPS) Pharma 360 conference in Washington, D.C.
Achieving the “moonshot”
He described how the company’s manufacturing strategy is changing to accommodate the production of a greater number of drug products at smaller volumes. As part of their “moonshot goals,” Roche aims to reduce the cycle from molecule to medicine to three years, and achieve a 10x reduction in the cost of goods for their drug products.
Robotics play a role in the strategy, with one of the initial projects focused on the integration of Vanrx’s SA25 Aseptic Filling Workcell into the manufacturing network of Roche, and its wholly owned subsidiary Genentech.
The first SA25 is now installed at Genentech’s South San Francisco site, following its purchase in February 2018 and its factory acceptance test in August of the same year. Mr. Stübchen said that the total project timeline is expected to be 18 months from purchase through qualification, validation, and media fills, until the user handover.
Mr. Stübchen’s presentation cited short lead times, low capital expenses, versatility in handling different container formats, and standalone utility requirements as reasons for the SA25 Aseptic Filling Workcell’s selection.
Network strategy for aseptic filling
Mr. Stübchen described a network strategy for Roche in which further SA25s will be installed at other Roche/Genentech manufacturing sites. The company will scale out, rather than scaling up. Stübchen emphasized that by ensuring identical equipment in development and manufacturing, technology transfer timelines and cost will be significantly reduced .
Sites would prepare a cleanroom, and be provided with a standard set of documents for equipment commissioning and qualification which is designed to be applicable and mandatory for use in the entire network. By following this strategy, adding new systems to the network will be faster and more effective. a factor that can be leveraged to supply innovative medicine to patients in a timely manner, at low cost.
Learn more at the ISPE Europe Aseptic Conference
Mr. Stübchen will also present “Small Volume Modular Filling Unit – a Highly Automated Gloveless System for RTU-Components” at the upcoming ISPE Europe Aseptic Conference on November 29 in Vienna, Austria.