by Tom Hartman, President and CEO of the International Society for Pharmaceutical Engineering (ISPE)
Dedication to providing patients with high-quality, safe, and effective treatments is at the heart of all biopharma. Just as therapeutic modalities have evolved beyond traditional small-molecule pharmaceuticals into the modern era of advanced biologics, mRNA vaccines, and cell & gene therapies, the infrastructure supporting their manufacturing has undergone a parallel evolution.
The Facility of the Year Awards (FOYA), administered by ISPE, honors cutting-edge pharmaceutical manufacturing facilities, including leading innovators in biopharma. These annual awards recognize excellence in categories such as Innovation, Operations, Supply Chain, Social Impact, and Pharm4.0– a measure of end-to-end integration of advanced digital technologies.
While each FOYA category recognizes just one or two winners, numerous shared trends have emerged during the submission process that may hold the key to successful biopharma facility projects.
Trend 1: Thoughtful planning for sustained safety and adaptability.
The foundation of a successful biopharma manufacturing project lies in a strong and thoughtful design from which the entire project can take shape. The first emerging trend across 2023 FOYA Category Award winners was the significant focus on an adaptable design, which ultimately enables efficiency, mobility, and safety. In the wake of extensive global drug shortages and supply chain issues, winning facilities are considerably more efficient and adaptable than their predecessors, emphasizing the ability to mobilize quickly in response to public health needs.
Standard pharmaceutical manufacturing facilities require the confinement of multi-product production steps and their corresponding teams to protect product quality and worker safety. However, advances in automation and single-use technology are changing this standard, making it simpler to prevent contamination across production lines. 2023 FOYA category winners leaned on designs that reduced or eliminated the separation between teams altogether, enhancing collaboration while increasing facility adaptability. For example, Genentech, the 2023 Pharma 4.0 winner, utilized a unique, centralized ballroom design that simplified utility lines and teams. This change has made the facility largely product-agnostic in design, starkly contrasting with older facilities that are often highly tailored for a specific product. Other facilities, like Nexus Pharmaceuticals’ Project Tomorrow, the 2023 FOYA Honorable Mention, used careful architectural design to reduce obstacles, maximize space, and enhance the team’s ability to swiftly decontaminate and switch product “campaigns,” facilitating real-time responsiveness to drug supply shortages.
Beyond operational efficiency and product flexibility, a thoughtful design can also protect workers from potential occupational health hazards. Manufacturing certain API and drug product(s) can pose considerable safety risks that necessitate stringent safety protocols and adequate equipment to minimize potential occupational exposure. Chugai Pharmaceutical, the 2023 Innovation category winner, began addressing these risks at the design stage, ensuring the selection of optimum containment equipment (including mobile isolators and innovative pressure control technology), performing rigorous assessments of containment performance, and refining designs based on performance testing. These design-stage steps ultimately contributed to an impressive Occupational Exposure Limit (OEL) score that reflects a safe workplace.
Trend 2: Attention to a positive community impact
Once a concept design for constructing a new facility is established, the facility's location must be carefully selected to meet individual manufacturing objectives. However, winners of the 2023 FOYA categories also paid close attention to the local communities in which their facilities were built. From a facility in rural Wisconsin, USA, to a project positioned in a Japanese metro area, winners took care to support community initiatives, like volunteering efforts, while utilizing the local workforce.
The construction of a large manufacturing facility can be taxing on the local community, but winners showed extensive care to reduce their impact. WuXi Biologics, the 2023 Operations winner, hand-delivered newsletters to locals that detailed ongoing construction activities, manufacturing products, and expected impacts on the local economy. They also constructed separate roads for construction vehicles and took care to respect the history of the site when archaeological remains were found. Ultimately, the facility was completed in 26 months and led to the hiring of 350 full-time employees.
In addition to supporting local communities, the SERUM Institute, the 2023 Supply Chain and Social Impact winner, produced millions of doses of COVID-19 vaccines, providing a case study for supporting the global community. Initially built to manufacture a variety of marketed vaccines, this project instead pivoted to the manufacture of COVID-19 vaccines to address the ongoing global pandemic. The facility produced commercial-scale COVID-19 vaccines within an impressive six months from the start of the design modification to the first batch of dosed vaccines. This exceptional achievement was made possible through the repurposing of the manufacturing facility and modification of equipment, an effort that required careful planning to implement and will serve as a case study for future global health crises.
Trend 3: Commitment to sustainability and environmental protection
In addition to adaptable design and community impact, FOYA award winners also shared a commitment to sustainability. While many facilities employ a handful of sustainability features, future trends include careful, sustainability-minded planning from the design stage on, along with the careful examination of every stage of the manufacturing process.
Takeda, the 2023 Social Impact – Sustainability category winner, exemplified sustainability efforts. Despite focusing on plasma-derived therapies that are notoriously water- and energy-intensive to produce, the facility sources 100% of its energy from renewable sources, including 8,000 solar panels and, in the future, geothermal wells and wind turbines. To reduce water use, the facility is the first pharmaceutical manufacturing site in the world to recycle its wastewater to drinking water standards and reuse it in the production process. This system is helping the site reduce up to 60% of its freshwater withdrawal. The site also manages its other waste through either recycling or incineration and is operated entirely paperless.
Other sustainability features that are sure to carry into future facilities include performing lifecycle assessments to examine the future impacts of facilities, incorporating more environmentally friendly products into production pipelines, consolidating workflows and equipment to reduce water and energy costs, and forming employee sustainability committees to drive further adaptation.
Trend 4: Adoption of integrated automation, digitization, and AI
Pharmaceutical manufacturing is not exempt from the integration of AI and automation. Among 2023 FOYA category winners, streamlined facility designs paired with the digitization and automation of processes resulted in a slew of benefits, including increased safety and operational efficiency.
Automation and AI simplify quality control protocols, providing a secondary quality check and validation for products while reducing the number of team members needed across the entire production pipeline. Winners also used increased digitization to streamline operations, reducing the need for paper copies of records that can be easily lost or damaged.
While automation, digitization, and AI are technologies that still require extensive validation and planning for design teams, their impact on the 2023 FOYA Category winners and the industry at large is a clear sign that their role will only expand. Ultimately, facility trends suggest that automation and AI will be worthy partners to pharmaceutical manufacturing efforts in years to come.
Looking ahead
Beyond achieving excellence in their individual categories, the 2023 FOYA Category Winners have exemplified the benefits of integrating a variety of emerging biopharma manufacturing trends into their ecosystems. While current manufacturing standards are reliable and well-known, it’s clear that enhanced efficiency, safety, and speed are within reach when manufacturers push beyond the expected. The success of these facilities represents the likelihood of these design, construction, and operational trends to continue to permeate the industry and change the design of future facilities well into the next decade.
About the author
Tom Hartman, BS ME, MBA, is the President & CEO of ISPE. Based in Bethesda, Maryland, ISPE is a not-for-profit organization committed to advancing scientific, technical, and regulatory solutions for the development and manufacture of safe and effective therapeutics. Tom is a respected thought leader with vast expertise in biopharma manufacturing, GMP operations, and engineering.