“We wanted to break away from the typical customer-vendor relationship. The feeling that we both can contribute and develop something new together makes it more meaningful and builds a stronger relationship”, says Takuo Kawase, API Process Development, Chugai
Through the development of a new smart factory concept, Japanese pharmaceutical company Chugai has set an ambitious goal: cut therapeutic antibody manufacturing costs by more than 50%. To get there, the company sought to drive efficiencies across the following key areas:
- Factory construction time
- Footprint and capital expenditure
- Running costs
- CO2 emissions and energy consumption
Fig 1. Cytiva and Chugai have developed an integrated semi-continuous biomanufacturing solution for a smart factory for drug manufacturing.
But Chugai couldn’t take on this enormous task alone. The company needed to find new solutions to achieve their targets and believed that working with an external organization would help them turn their new ideas into reality. Through a collaboration with Cytiva, Chugai has been able to focus on creating an integrated semi-continuous biomanufacturing solution for downstream operations (Fig 1).
“Our expertise lies in process development and manufacturing, but we need a partner for hardware and system control development. This way we push the innovation further,” says Takuo Kawase, Chugai.
The Custom Engineering (CE) team at Cytiva ― bringing application expertise, engineering, hardware, electronics, software, and quality control together ― has a well-established project model for the development and manufacturing of custom equipment (Fig 2). They offer comprehensive support, starting with an agreed upon conceptual design and ending with product delivery. There’s also a strong focus on quality and regulatory rigor all the way from project start until the equipment is up and running at customer’s site. This highly collaborative approach has allowed Chugai to share ownership of its complex project and ensure everything stayed on track.
Fig 2. The Custom Engineering department at Cytiva has a well-established project model.
To kick things off, Cytiva conducted an engineering study, mapping all of the systems required for each of the downstream steps. From there, the team designed an automation control solution ― dubbed “traffic police” ― to allow the process to run in a continuous mode for several days, or even weeks (Fig 3). Cytiva also developed new single-use systems for the viral inactivation and filtration steps (Fig 4),
“In early discussions with our automation experts, we realized the importance of not just looking at how the process should normally be controlled in a batch mode, but we also carefully looked into how to handle any disruption. This was more important than normal since the equipment was being designed for use in a continuous process. For this project, we recommended certain functionality “under the hood” that should not normally be activated but becomes very important if something unexpected happens,” says Per Karlberg, Business Leader for custom hardware at Cytiva.
Fig 3. A “traffic police” automation solution was designed to control the connected, semi-continuous biomanufacturing process train.
Fig 4. Cytiva custom-designed a single-use viral inactivation system for Chugai’s pilot plant.
Cytiva first tested the pilot-scale solution at the Custom Engineering (CE) department in Uppsala, Sweden before moving to Chugai’s facility in Kita-ku, Tokyo. On site, the new equipment is performing just as the Chugai team expected.
Next steps for smarter therapeutic antibody manufacturing
Following the concept’s success at a pilot scale, Chugai and Cytiva are exploring the technical and business feasibility of scaling their model up. The lessons learned along the way are paving the path towards smarter, more cost-effective drug manufacturing for the future.