3 Pathbreaking Trends from 2023’s Award-Winning Pharma Manufacturing Facilities

Tom Hartman, BS ME, MBA, is the president & CEO of the International Society of Pharmaceutical Engineers (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. Hartman is a respected thought leader with vast expertise in biopharma manufacturing, GMP operations, and engineering sectors.

Providing patients with safe, effective, and high-quality care is at the heart of the pharmaceutical industry. Pharmaceutical manufacturing facilities have evolved to accommodate multiple product modalities, including traditional small molecule, large molecule, or biotech facilities, and advanced therapy platforms such as cell and gene therapies. The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) recognizes excellence in design, construction, and operability in such manufacturing facilities, and awards them for Innovation, Operations, Supply Chain, Social Impact, and Pharma 4.0™ Digitization. Here, we explore the trends that have emerged among awardees this year.

1. Thoughtful design for improved safety, efficiency, and adaptability

The first trend across 2023 FOYA winners is facility designs that enhance operating efficiencies, support a safe work environment, and enable flexible manufacturing while minimizing cross contamination. Efforts to incorporate manufacturing process automation and single-use technologies to prevent cross-contamination of products stand out in this category.

Genentech, the 2023 FOYA Category Pharma 4.0™ Winner, uses single-use technologies to support its centralized ballroom, or open floor plan, design. These changes simplify utility lines, reduce team isolation, and make the facility design largely product-agnostic. This contrasts with older facilities tailored for a specific product. Other facilities, like the 2023 Honorable Mention winner, Nexus Pharmaceuticals, Inc., paired automation with careful architectural design to reduce obstacles, maximize space, and enhance the team’s ability to swiftly decontaminate and switch product campaigns.

A thoughtful design also protects workers from potential occupational health hazards posed during the manufacturing of drug products. Chugai Pharmaceutical Co., Ltd., the 2023 FOYA Category Innovation Winner, addressed these risks by selecting optimum containment equipment, rigorously assessing containment performance, and refining designs based on performance testing.

2. Focus on community impact

Location is critical for the success of any facility, but the winners paid particular attention to the local communities their facilities support by engaging in initiatives to offset potential negative impact on their lifestyle.

WuXi Biologics, the 2023 FOYA Category Operations Winner, showed extensive care for the community, even during construction. The team established separate roads for construction vehicles and hand-delivered newsletters that detailed construction activities and expected impacts.

In a case study for supporting the global community, SERUM Institute, the 2023 FOYA Category Supply Chain and Social Impact Winner, abandoned preexisting facility plans in order to manufacture COVID-19 vaccines in late 2020. Initially built to manufacture a variety of marketed vaccines, the Institute’s facility produced millions of doses after only six months of facility modification and product scaling efforts.

3. Commitment to sustainability and environmental protection

While many manufacturing facilities retroactively employ sustainability features, FOYA Category Winners exhibited a shared commitment to sustainability-minded planning from start to finish.

Takeda SA, the 2023 FOYA Category Social Impact Winner, focuses on plasma-derived therapies that are water- and energy-intensive to produce. To combat this caveat, the facility sources 100 percent of its energy from multiple renewable sources. It also reduces up to 60 percent of its freshwater withdrawal by recycling wastewater to drinking water standards and reusing it in the production process—a first in the industry.

Other sustainability features adopted by the winning facilities include examining future impact using lifecycle assessments, incorporating more environmentally friendly products into production pipelines, and consolidating workflows and equipment to reduce water and energy costs.

Looking ahead

Beyond achieving excellence in their individual categories, the 2023 FOYA Category Winners exemplified the benefits of pushing beyond reliable, well-known industry standards to achieve enhanced efficiency, safety, and speed. Their success indicates that these manufacturing trends will continue to influence the design of new facilities well into the next decade.