Meet the 2023 FOYA Operations Category Winner: WuXi Biologics Ireland Limited
Facility of the Year Award (FOYA) Winners in the Operations category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges, promoted effectiveness, and organized stakeholders and project team participants in ways that led to successful outcomes such as efficiency, delivery, quality, product yield, consistency, and cost of goods. Projects demonstrate a culture of continuous improvement behaviors, which yielded superior results. Additionally, these principles, systems, and tools ensure business continuity through a stable supply environment, health and safety, and customer satisfaction from existing or new facilities, processes, and manufacturing operations.
WuXi Biologics is a leading global Contract, Research, Development, and Manufacturing Organization (CRDMO) offering end-to-end solutions enabling partners to discover, develop, and manufacture biologics from concept to commercialization for the benefit of patients worldwide. WuXi Biologics has almost 600 global partners, including all the top 20 pharmaceutical companies.
Project: WuXi Biologics Ireland Drug Substance Manufacturing Facility
One of the Largest Contract Manufacturing Facilities Using Single-Use Bioreactors in the World
With over 12,000 skilled employees in China, the United States, Ireland, Germany, and Singapore, WuXi Biologic’s leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development, and manufacturing solutions. As of 31 May 2023, WuXi Biologics supports 613 integrated client projects, including 21 in commercial manufacturing.
WuXi Biologics built one of the largest contract manufacturing facilities in the world using single-use production technology. Located in Dundalk, Ireland, the multiproduct facility for manufacturing monoclonal antibodies (mAb) and recombinant proteins offers clients an innovative global entry point to bring new biological therapies to market. It represents Ireland’s only biological contract manufacturing facility.
Why They Won
The project was delivered successfully on time, within budget, and with an exceptional safety record: The IPS design-assist model, along with the agility with which the Jacobs team navigated schedule disruptions from both COVID-19 and archeological digs, and ABEC’s integrated solution, led to an impressive 26-month schedule completion. The project took over 6,200,000 hours to complete, backed up by an impressive 0.35 recordable injury rate (TRIR). The final 13 months of construction (about 3,000,000 hours of work) were completed without a single recordable event.
At the core of the facility are two manufacturing areas referred to as Manufacturing Six (MFG 6) and Manufacturing Seven (MFG 7). As the names imply, these manufacturing areas are, in both theory and practice, a functioning part of a global chain of WuXi Biologics manufacturing facilities, which allows for flexible scaling of production across the globe.
Indeed, the “scale-out” aspect of the facility provides an unprecedented capacity to the European market. The facility has the ability to use multiple 4,000-liter single-use bioreactors to create up to 48,000-liters of capacity at the production stage to grow batches of product. While most biopharmaceutical facilities are developed to support a single product, this facility was purpose designed to facilitate the production of any clients’ cell culture-based biological therapeutic.
WuXi Biologics partnered with vendors to develop a number of innovations that will allow the facility the flexibility it requires to meet the needs of clients for years to come, including:
- A highly-configurable fed-batchsingle-use bioreactor system
- Large gravity-fed buffer system designed to allow the fine-tuning of buffer volume and consideration
- Automated bulk-filling skid for bags and bottles that sidesteps a labor-intensive manual process
Emerging Technologies
Data “analytics” and data “mining” have been extensively deployed in order to monitor, trend and perform both real time analysis on batch performance and well as a retrospective comparison – aiding both process transfer works and product optimization programmes.
An extensive in-house capability of laboratory function exists on the WuXi Biologics Dundalk site as well as within the wider network. Analysis backed by the latest technologies, extensive mapping of key WuXi Biologics processes and carried out by highly skilled laboratory staff to support our client needs at all stages of the manufacturing process.
Unlike traditional preventative maintenance, WuXi Biologics emphasizes “predictive maintenance,” which uses techniques such as ultrasound and thermography to characterize potential problem areas across the facility. Predictive maintenance is performed across all mechanical bearings, pumps, fans, motors, steam traps, valves, heat exchangers, electrical panels, and insulation lagging integrity. It provides a means of detecting potential gas leaks.
Flexibility/Adaptability
The facility is built for maximum flexibility and reliability. To take advantage of ABEC’s and other providers’ capabilities, WuXi Biologics engineers developed what they call the Facility Fit Tool. The tool is essentially a catalog of materials that will meet an estimated 99% of anticipated needs, so they do not have to source bespoke materials from vendors. The Facility Fit Tool enables them to create new assemblies from a vast stock of materials, whether it involves single-use bioreactor bags or specific bulk-fill components. The tool also allows engineers to improve processes to increase yields while remaining within the scope of approved filings for the given process. Moreover, the tool will decrease the time it takes to transfer MFG 6 or 7 to a new cell culture process by removing the procurement of consumables from the equation.
Sustainability
Environmental impact and sustainability were key considerations across the design, construction, and function of the WuXi Biologics Ireland facility. Indeed, as the largest assembly of single-use bioreactors currently in use, the facility dramatically reduces the amount of wastewater it generates and has recently launched and completed a number of key projects to launch the Sustainability journey on site, e.g. expansion of site charging points, Rain water harvesting for grey water uses, installation of solar panels etc.. Further works are also in the pipeline including ISO accordion in 2023/2024.
Scale-out Manufacturing
The WuXi Biologics Ireland facility avoids the risks inherent in scaling up cell culture production processes by “scaling out” with 12 ABEC 4,000-liter capacity bioreactors. WuXi Biologics can smoothly increase production rates by applying multiple high-capacity bioreactors to culture cells. As cell culture processes are transferred from other WuXi Biologics sites for mass production, the scale-out system decreases capital, facility, and disposables costs by doubling capacity in approximately the same floor space.
As a result of using single-use bioreactor systems, the facility can efficiently and quickly transfer between client runs without the risk of cross-contamination or waiting for bespoke systems to come online. This modular approach to the manufacturing process is novel and allows WuXi Biologics to offer clients unprecedented flexibility within a single site.
Want to Learn More?
Attend the 2023 Facility of the Year Awards Celebratory Reception and Banquet on 15 October at Mandalay Bay Resort in Las Vegas, Nevada, USA held in conjunction with the 2023 ISPE Annual Meeting & Expo.
Nominate Your Facility for the 2024 Foya Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2024 FOYA program winner. Applications must be submitted by 4 December 2023.
