Roche / Genentech
As a global biopharmaceutical company, Roche/Genentech has produced drug products for millions of patients around the world. However in their move towards focusing on individualized treatments, they recognized the need to completely transform their manufacturing operations. They required a “paradigm shift” in respect to asset strategy and new ways of working to keep up with the complex needs of advanced therapies.
So, how did they do it?
The following information was presented by Markus Stübchen, Roche’s Global Technical Lead for Sterile Manufacturing and Robotic Network Team at the 2018 American Association of Pharmaceutical Scientists (AAPS) Pharma 360 conference in Washington, D.C. and Sven Hauptmann, PhD, Roche’s SVP Global Product Manufacturing at the 2019 PDA Annual Meeting in San Diego, CA.
Achieving the “moonshot”
Roche/Genentech recognized that manufacturing individualized treatments would bring future challenges in terms of:
- smaller batch sizes
- higher efficiency
- reducing costs
- avoiding human error
- increasing flexibility
- reducing tech transfer efforts
In 2018, the company unveiled their “moonshot goals” outlining their aim to reduce the cycle from molecule to medicine to just three years and supply current and future products to patients at the lowest cost and highest quality.
Roche recognized that achieving these goals would require a “paradigm shift” which meant moving from traditional cleanrooms to gloveless isolators and leaving the conveyor belt behind to leverage ready-to-use nested containers and press-fit caps.
Robotics also play a role in the strategy, so 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 was 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, with a total project timeline of just 18 months – from purchase through qualification, validation, media fills, and user handover.
Network strategy for aseptic filling
In devising this strategy, Roche also recognized the value in scaling-out rather than scaling-up.
The benefits of increased flexibility and elimination of tech transfer costs would outweigh the economy-of-scale savings of scaling up when it comes to small and mid volume drug products.
Roche’s network strategy set out that further Aseptic Filling Workcells would be installed at Roche/Genentech manufacturing sites all over the world. Standardization across the network and between clinical supply and commercial manufacturing would eliminate tech transfer efforts and costs. In the end, this would leverage the supply of innovative medicine to patients in a timely manner at low cost.
Implementing the strategy
In the two years since the launch of their “moonshot goals” and the installation of the first SA25 Aseptic Filling Workcell, Roche/Genentech have expanded their network strategies beyond filling into bioprocessing and secondary packaging equipment. Vanrx SA25s are now installed in three manufacturing locations, while multiple Microcell Vial Fillers are also in use.
Vanrx Aseptic Filling Workcells were selected as the global platform to implement this strategy based on their short lead times, low capital expenses, versatility in handling different container formats, and standalone utility requirements.
Ensuring high quality output was another essential factor in Roche’s decision. The Vanrx Workcells’ lack of glove ports eliminates operator intervention, while the robotic handling of nested vials means no glass-to-glass contact and minimal change over time for optimal quality.
With multiple standardized workcells now installed at various locations, scaling-out instead of scaling-up as a network strategy is also helping Roche to achieve faster technology transfers, faster Capex projects, less process changes, and centralized maintenance, training, and spare parts.