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Breaking with tradition, a compounding facility won for overall operational excellence, while biopharma facilities took home awards in various categories.
Reflecting the changing nature of current good manufacturing practices (cGMPs) and pharmaceutical manufacturing, a compounding pharmacy won the International Society for Pharmaceutical Engineers (ISPE’s) overall award for operational excellence in the 2019 Facility of the Year Awards. Eli Lilly won this year’s award for process innovation for a continuous manufacturing facility, while biopharmaceutical manufacturing facilities won awards for project execution and integration, sustainability and for the Facility of the Future.
The awards were distributed at the organization’s annual meeting in Las Vegas, NV on Nov. 1, 2019. Below is more information about this year’s winners.
According to ISPE, the competition judges found that this project “establishes a new norm for future facilities.” It replaced and integrated two pharmacies that had been unable to keep up with the evolving needs of the community, and was designed to ensure that all products were made under industrial cGMP conditions, as required by FDA.
According to ISPE, the center is using operational excellence principles and has reduced to between 60 and 90 minutes the time required between patient diagnostic testing and prescription to patient treatment. In addition, the center is training pharmacists in cGMP and producing test kits for between 60 and 80 clinical trials.
Eli Lilly’s continuous drug substance manufacturing facility won ISPE’s award for process innovation for its small volume continuous (SVC) facility, which targets pipeline products with an annual volume less than 1.5 metric tons. The 10,000 square foot facility’s design features a “wheel and spoke” layout with a suite of dual access fume hoods surrounding a central core of 75-L feed vessels as well as liquid and solid feed charging rooms. The continuous unit operations are provided on mobile skids that can be interconnected and configured in multiple ways. The skid modules and feed vessels are interconnected with flexible tubing that can be dedicated to product or disposed of after use. Continuous process skids include plug flow reactors, continuous stirred reactors, distillation, extraction, filtration, and crystallization.
According to this year’s judges, the facility advances existing technology in three areas:
Use of process analytical technologies and advanced, plug-and-play automation to facilitate real-time process control, the development of new continuous technologies, and significant improvement in process safety and environmental impacts.
The facility, which uses online high-pressure liquid chromatography (HPLC), features modular processing skids that can be configured and controlled based on requirements, and that are recognized by the facility’s distributed control system, which can control them individually or grouped with other skids.
The facility allows for continuous unit operations using established technology but also a new mixed suspension/mixed product removal technology for continuous crystallization, which is said to improve impurity control in batch crystallization by a factor of 20. Another innovation is the use of continuous automated filtration with re-dissolve/re-suspend capability. As the judges noted, the equipment is much smaller than traditional process equipment (i.e. from 5–30 L) and enclosed, significantly reducing the risk of operator exposure. Principles of process safety management governed process design, based on the preferential selection of lower temperatures and pressures as well as the smallest quantities of solvent, catalyst and hazardous chemicals.
The 2019 FOYA award for sustainability was given to Celgene for its Green Fairy project in Couvet, Switzerland. The project incorporates an overall site energy concept that uses geothermal and recovered energy, producing electricity using photovoltaic solar panels installed in the main building’s rooftops at the site. Overall, the site’s design is expected to reduce greenhouse gas emissions by approximately 1400 metric tons per year of CO2. This is equivalent to 70% CO2 emissions reduction compared to a standard installation and building construction
The Pfizer Global Biotechnology Center (GBC) in Hangzhou, China was Pfizer’s first biotechnology project in China and represented its first use of 2000-L disposable bioreactors, utilizing the GE Healthcare KUbio system. This platform allows the company to develop new processes in Massachusetts, and then manufacture product in Ireland, North Carolina, or Hangzhou. Having identical platforms with the same hardware and software is designed to improve tech transfer. The installation is modular, based on 77 modules (9.6x4.5x4 meters each) that were built in Germany and then shipped to Hangzhou, China for assembly.
The site master plan utilizes a central spine corridor to connect the drug substance, drug product, warehouse, central utilities building, and administration. Each functional area has provision for significant future capacity. For example, the drug substance facility is initially fitted with two 2000-liter bioreactors with provision to double to four 2000-liters (8000 liters in total). The drug product facility is initially fitted with one formulation suite, filling line, and integrated lyophilizer and has ample space to add a second formulation suite, preparation area, filling line, lyophilizer, and multiple automatic inspection and packaging lines. The idea is to enable distinct work areas for different functions, but in a way that allows them all to be controlled in parallel.
The Hangzhou, China, facility also won for best overall project execution, in particular for its site master plan, use of identical platforms, standardization and integration, which guided the very earliest stages of facility design, allowing the work to be completed within 25 months. In particular, FOYA judges noted the design’s allowance for optimizing functional adjacencies, minimizing travel distances, and allowing for easy expansion in the future.
Moderna’s Norwood therapeutics and vaccines facility was awarded for what FOYA judges called a highly flexible and adaptable design, capable of manufacturing for both clinical and research work. The facility’s digital production environment, the judges said, was designed to enable high throughput with a robust and diverse set of products. The enterprise and process control systems are integrated in a manner that enables flexibility and rapid new product introduction in a highly-automated landscape. Judges also praised the use of digital technology throughout the site, including the integration of the enterprise resource planning system with electronic production records, process control systems, the data historian, and laboratory information management system.
Janssen’s Dosepak Equipment project won the 2019 FOYA for equipment innovation, in a collaboration that involved the user of the technology, Janssen Latina Engineering Department, as well as the technology provider, C-Matic srl, the integrator, ECCT B.V., and the packaging designers (WestRock and Schreiner-MediPharm). The overall system integrates advanced robotics and automation into standard packaging process steps, the judges noted, enabling lean, flexible and sustainable manufacturing.
The work aimed to improve patient adherence to medication through the use of smart packaging. Janssen Cilag introduced I-Smart technology, applied through microchip onto blisters. The technology leverages near-field communication to send signals to a smartphone and remind patients to take their medications and monitor their adherence to the therapy.
In addition, the project aimed to allow new products to be introduced faster, to allow a wide range of products to be made on the same equipment, and to improve patient safety by adding tamper resistant features and traceability through digitalization and smartphone connection.
The resulting Dosepak equipment allows multiple tasks to be performed continuously in one machine, including:
The technology reduced cycle time by a factor of ten compared with traditional manual processes, the judges said.
Honorable Mentions were given to AveXis, a gene therapy developer based in Chicago, for its proprietary investigational gene replacement therapy manufacturing facility that uses single-use technology and a modular design, as well as innovative manufacturing equipment.
Takeda Pharmaceutical Company Ltd (formerly Shire), also won Honorable Mention for its new plasma processing and distribution center near Covington, GA, the foundation of a strategy designed to ensure global delivery through an integrated network of donor centers, testing laboratories and manufacturing facilities. In addition to being one of the nation’s largest greenfield site projects, FOYA judges noted, the project was executed under three different corporate entities from start to finish (Baxter, Baxalta, and Shire) without ever losing focus on an safety, achieving more than nine million staff-hours through a period of four years with zero fatalities and only three cases of lost workdays.
ISPE FOYA Webpage, October 2019