2024 ISPE Facilities of the Future Conference: Keynote Presentations
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California, with a series of six keynote presentations on innovations that are leading to advanced manufacturing facilities. Thomas Hartman, President and CEO of ISPE, introduced each of the keynote speakers.
Keynote Speakers
The first speaker, Karl Kogelmueller, Takeda Manufacturing Austria AG, described the ways Takeda is embarking on a digital transformation journey to meet its goals of creating an uninterrupted supply chain, taking care of its internal resources, and ensuring sustainability.
Carlos Santiago, of GlaxoSmithKline, outlined the design of his company’s first integrated vaccines and research and development (R&D) building. Because almost three-quarters of the retrofit will be dedicated to lab space, the design was optimized for efficiency and includes offsite storage and service delivery.
Carla J. Lundi, Office of Quality Surveillance, FDA/CDER, described the work of her office in supporting quality in pharmaceutical manufacturing to counteract shortages of essential medicines. Key to this work is CDER’s quality management maturity program.
Patricia Martin, Martin Equity, LLC, spoke about the value of the human resources that are essential to the workforce of the future. She spoke about worker dissatisfaction and aspects of a work situation that can be controlled to mitigate this by factors that are under the control of management.
Christian Randecker, Genentech, described the design of a new clinical supply center, which is flexible, uses innovative technologies, and can be replicated for clinical or commercial production.
Deborah Donovan, Moderna, shared her company’s ambitious goal of achieving net zero emissions by 2030, mostly by reducing energy use onsite, relying on renewable energy production, and offsetting emissions with renewable energy certificates.
End-To-End Supply Chain Digital Transformation
Kogelmueller outlined the ways Takeda, as a data-driven organization, intends to use digitalization and automation for cost management in its manufacturing operations and supply chain. He listed the external challenges impacting biopharmaceutical supply chains, focusing on increased economic, financial, and geopolitical risks as a result of the war in Ukraine. Kogelmueller then spoke of the four phases in a digital transformation: building insights with pilot projects, capturing value through scaling, achieving scale, and becoming a fully data-driven organization. Unfortunately, he noted, half of companies are stalled during the second phase.
Takeda has a strategy to link aspects of its digitalization journey to its business goals, which include an uninterrupted supply chain, investments in upskilling its people, and environmental stewardship. Everything is wrapped up in roadmaps the company can refer to along its journey, not only at individual sites but throughout the organization.
This is coordinated by an upgraded continuous improvement program that starts with an architect workstream. It designs blueprints for the future-ready areas in the sites. A builder workstream follows, in which engineers and manufacturing science staff determine what technologies to use. The other two builder workstreams focus on enterprise excellence and organizational learning, ensuring continuous improvements and organizational change management and learning. Kogelmueller stressed that continuous improvement is the baseline for transformational changes.
Despite its momentum, Takeda faces challenges. One of these is the enterprise-wide complexity of having large numbers of operating units in plasma biologics, molecules, and small molecules; multiple sites; and thousands of SKUs. To overcome this, it understands the need to systematically use its strategy and value creation, and combine both, to prioritize initiatives. Digital transformation requires a strong governance body—such as a top-level steering committee—capable of making tough decisions. By using all this, it can deal with that complexity and implement the transformation as planned. Such a transformation also requires training employees in new competencies, developing new ways of engaging workers, and ensuring their well-being.
Building a Workplace of the Future Within a Research Site
Santiago described the creation of a workplace of the future for GSK’s research scientists based on what the company had previously applied to its headquarters and some commercial facilities. This is a retrofit designed for a roughly 200,000-square-foot building in Cambridge, Massachusetts, to be used as the company’s first integrated vaccines and infectious disease R&D center. Almost three-quarters of the building will be dedicated to lab space. To meet corporate sustainability goals, this retrofit will leverage heat recovery systems, use of sustainable materials, waste diversion, and water reduction.
To accomplish this, vaccines R&D will be moved from an existing facility—which will be decommissioned—into this building. The transition requires change management to avoid disrupting the existing pipeline by having two teams, integrated plans, and redundancy in some equipment and science.
Employee Well-Being Is Imperative
Knowing talent is tough to attract and retain, GSK aims to foster an engaged workplace, using a design that focuses on worker well-being and health. The space is designed to meet WELL Gold standards, incorporating active design principles, integrating lab spaces with the natural surroundings, ensuring good air quality, and providing attractive amenities. Accessibility is ensured by overcoming physical barriers, adding assistive equipment, and including ergonomic workstations. Technology is used to simplify the work environment, such as a comprehensive app for wayfinding and other logistics.
The design encourages collaboration and is flexible to meet contingencies of geography and culture of this, or any, location. With the advent of more remote work, the design builds in allowance for partial attendance to optimize the size of the space. The design is flexible and, upon review, can be revamped over time to meet different conditions.
Offsite Provisioning Hub
Working with service partners, GSK will create an offsite provisioning hub to manage material storage and services that aren’t required for just-in-time delivery. This optimizes the use of prime real estate, improving efficiency in the lab.
Beyond CGMP: Proactive Quality Principles Today for Facilities of Tomorrow
Lundi talked about the work of the OQS to promote and support quality among pharmaceutical manufacturers. Currently, the OQS is most concerned with the global shortfall of critical drugs, particularly sterile injectables. The main reasons for new shortages are quality issues and manufacturing delays. She highlighted disruptions in the supply chain resulting in recalls and shortages, such as manufacturing reliability, active pharmaceutical ingredient (API) and key component availability, aging facilities, natural disaster and public health emergencies, economic upheaval, manufacturing site closures, and geopolitical issues. The top manufacturing compliance concerns contributing to shortages include microbial contamination, poor excipient quality, lack of data integrity, and inadequate controls.
A 2019 FDA report identified the root cause of drug shortages as the lack of quality management that focuses on continuous improvement and early detection of supply chain issues.
FRAME Supports Viable Solutions
A possible solution to shortages is the use of advanced manufacturing technologies. CDER applies the FDA Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) to support industry by issuing guidance on emerging technologies, clarifying regulatory and data requirements to support applications, and publishing discussion papers on artificial intelligence (AI) and machine learning. FRAME priority technologies are distributed manufacturing, end-to-end continuous manufacturing, point-of-care manufacturing, and AI. Guidance documents are designed to address regulatory concerns, including batch definition, process dynamics, change in production output, and continuous process verification.
The OQS currently focuses on opportunities for senior management oversight and manufacturing modernization, including automation, isolator and barrier technologies to improve the aseptic manufacturing of sterile injectables, and advanced quality management system approaches.
The FDA Quality Management Maturity (QMM) Program
A 2019 FDA report identified the root cause of drug shortages as the lack of quality management that focuses on continuous improvement and early detection of supply chain issues. CDER has defined QMM, which is a potential solution to drug shortages, as “the extent to which drug manufacturing establishments implement quality management practices that prioritize patients, drive continual improvement, and enhance the supply chain reliability through the strategic integration of business decisions and manufacturing operations with quality practices and technological advancements.”1
The goals of the QMM program are to:
- Foster a strong quality culture mindset
- Recognize establishments that advance and continually improve quality management
- Identify areas where quality management can be enhanced
- Minimize risks to product availability to ensure reliable market supply
A Federal Register notification published January 2024 announced that the FDA is soliciting drug manufacturing sites to voluntarily participate in a QMM program at CDER.1
Lundi concluded by saying that quality assurance requires everyone’s collaboration to protect the interests of patients through proactive management of supply chain complexities to ensure the availability of essential medicines.
Workforce of the Future: The Influence and Importance of People
Martin divided her presentation about the current state of workers and what they might need to evolve into the workforce of the future into concerns, conundrums, and control. She began by listing the most pressing employee concerns, which include the fear that automation is putting their jobs at risk, that they’re ready to be retrained, and that few will have stable, long-term employment.
Martin shared survey results showing that, although only 11% of people work remotely, they report being the most satisfied with their jobs, particularly when they get to make the decision to work remotely. Results also showed that more than one-third of those working onsite or hybrid are dissatisfied with their jobs. Many don’t have a choice to work remotely, including those in construction, labs, and manufacturing. This dissatisfaction could be due to several factors, but employers should consider what their workforce needs for their companies to deliver.
What Can They Control?
This level of job dissatisfaction matters to those in the pharmaceutical industry who are delivering the facilities that make essential medicines. Having a motivated and satisfied workforce can make or break a project and can directly impact the delivery of medicines to the people who need them most.
Martin used The 7 Habits of Highly Effective People, by Stephen Covey, to show what can be controlled to impact employee satisfaction. She talked about the need for people managers to focus on three things related to their workforce: concern, influence, and control. What are employee concerns? What influence does a manager have? What is under their control? She shared two tools to provide some control over the outcome.
The first is trust. Martin has found that trust depends on high credibility, reliability, and intimacy. Just as importantly, it relies on a low level of self-interest—a worker interested in the good of their team and their company is easier to trust. Trust is more difficult to establish for remote workers because they have fewer opportunities to interact in person.
The other tool she shared, called “getting the cow out of the ditch,” was a humorous, three-step process for problem-solving. Martin uses this to resolve critical problems, such as the time when her former employer was faced with an inability to make an essential portfolio drug product. The process involves the following steps.
- Get the cow out of the ditch, i.e., find an immediate solution
- Then, figure out how the cow got there
- Only then, determine how to keep the cow out of the ditch the next time
These tools work together. Trust is important because relationships with people are one-on-one, and a team can get out of a “ditch” if they give each other a hand.
Facility of the Future Design Philosophy Tensions for Genentech’s New Clinical Supply Center
Randecker shared the design of Genentech’s new clinical supply center, which ran its first current Good Manufacturing Practice (cGMP) batch in 2022. Genentech bucked its history of using stainless steel equipment for large-scale production. This allowed the transition in this facility to products for much smaller patient populations and more potent products with improved titers and yields. The mission was to build an agile, small-volume facility, leveraging new technologies, at unprecedented speed. The template design can be copied anywhere for commercial production.
Can Single Use Be Sustainable?
The facility relies fully on single-use technology (SUT), meaning nothing related to process or product is reused and, with no stainless steel, there is no need for clean-in-place, a parts washer, steam, or autoclaves. A life cycle assessment demonstrated that, although SUT generates considerably more solid waste, it has significant reductions in the use of energy and water, as well as aqueous waste, which tips the sustainability scale in its favor.
Flexible Design for Clinical and Commercial Production
The constraint of needing one design for both clinical and commercial production led to innovation. Utilities requirements were tweaked so clinical processes in one workcell could operate successfully at 50- to 2,000-liter capacities, with the option to reconfigure the layout without restrictions. By reconfiguring the layout, a consistent layout for commercial production was produced.
This design can be replicated identically in a new facility, including standard automation, equipment, consumables, procedures, and training. At the highest level is a single enterprise risk management (ERM) tool for taking in all process definition data, then pushing it out to execution and control sys-tems. This gives a common feel for operators in this or any copy facility and provides modular components, a flexible and adaptable system, and a more efficient and scalable network.
An Inspection-Ready Ballroom Design
Closed processing allowed an ISO 9 ballroom design, which maintains flexibility, optimizes material flow into and waste out of the facility, and improves sight lines. Compliance concerns, particularly about the lack of a wall between pre- and post-viral steps, were overcome by developing a lay-ers-of-protection approach, with multiple layers of controls to prevent failures, followed by continuous improvement.
Expanding Globally While Achieving Net Zero
Donovan outlined Moderna’s plan to meet its goal of net zero emissions by 2030 while expanding globally. Although its overall emissions have increased since 2021, mostly due to expansion of its existing facility, the global expansion—four manufacturing facilities under construction, two laboratories, corporate headquarters, and R&D headquarters—has contributed little to this increase due to sustainability initiatives incorporated into the new buildings.
Moderna’s strategy encompasses sustainability by design, natural resource conservation, and decarbonization of the value chain. It has the benefit, as a platform company, of needing a limited number of materials and suppliers, most of which already have science-based targets and are committed to net zero themselves. The sustainability strategy depends on data to assess the current state, quantify carbon emissions, and monitor, manage, and control emissions to continuously improve.
All the company’s scope 2 emissions (i.e., from purchased energy, including electricity) are offset by purchasing renewable energy certificates. Scope 3 emissions are more than 90% of Moderna’s emissions, the largest of which is purchased goods and services, including from contract research and manufacturing organizations and clinical activities.
Over the next two years, Moderna will focus on energy efficiency projects at its existing site. This will then allow it to transition from natural gas-fired equipment to heat pumps, having determined electricity needs and sized the necessary equipment. This gives the local utility company time to upgrade its equipment to meet the facility’s future electricity demands.
The 2025 ISPE Facilities of the Future Conference will be held in San Francisco, California, 27–28 January.
Sustainability and LEED standards were incorporated into the design of the new buildings. There is one design for three of the facilities, all of which are electric. Its corporate headquarters is slated to be the most energy-efficient building in Cambridge, Massachusetts. Sustainability measures will be built in, including a focus on embodied carbon, design for resilience in case of a natural disaster, and aims for Fitwel and WELL certification, as well as LEED Platinum and LEED Zero once in operation. It will have heat pumps to provide both heating and cooling throughout the lab building, solar panels on the roof, harvested rainwater to supply the chiller plant, and electric vehicle charging. Electricity will be supplied by onsite and offsite renewables.
The roadmap to net zero includes starting up the new facilities, gathering baseline information, submitting a greenhouse gas roadmap for validation by the Science-Based Target initiative (SBTi), and continuing to enhance energy programs and greenhouse gas management programs.
Executive Forum Panel
Supported by ISPE’s Women in Pharma®, this panel of six industry leaders was moderated by James Breen, ISPE Foundation Board Liaison and Vice President, Global Engineering and Technology at Johnson & Johnson Innovative Medicines. Martin, Lundi, and Donovan, who also gave keynote presentations at the conference, participated in the panel. The other speakers were Melody Spradlin, Vice President, Global Workplace Services, KLA; Katrina Moseley Journey, Vice President of Commercial, Luminopia Inc.; and Muriel Campbell, Senior Director of External API Manufacturing, Eli Lilly & Co.
In a wide-ranging and lively discussion that lasted more than an hour, the speakers provided a range of viewpoints based on their expertise in sustainability, engineering, regulations, marketing, and investing. They shared insights into the ways in which the transition to facilities of the future has impacted their careers and how they have responded to it, the ways others can prepare for an increasingly uncertain future, and how the industry can ensure sustainability is achieved. Here are a few of the many highlights from this discussion.
When Martin was asked how she thought people should prepare themselves for the coming changes, she joked that they should get a crystal ball. Then, seriously, she recommended gathering as wide a range of information as possible, and not limiting it to what is fed to us or what we already know.
Campbell, who was trained in Puerto Rico and raised her young family there, shared a pivotal moment in her career when she was recommended for an assignment in Indianapolis. It meant moving her three school-age daughters to a new place, but the move took her out of her comfort zone and expanded what she knew. She said it had been a big leap but is working out for the best for her family and her career.
Given the uptick of remote work, there is a concern about maintaining engagement for older workers who may prefer remote work and younger workers who may struggle networking when they aren’t with their colleagues in person. Moseley Journey, who works for a healthcare tech company with a multigenerational workforce, said she makes a point of meeting with others to give them a connection to the company and help them get more comfortable expressing themselves. She believes it’s incumbent upon the leadership team to reach out to younger or new staff to ask questions that are not about their core job such as, “What do you want to do with your life?” and “How are you thinking about the world around you?”
Many panelists wanted to answer what the biggest thing is that they’ve learned from being involved in ISPE. Spradlin credited ISPE as one of the reasons she was able to move ahead in her career. She referred to the network of women who were leaders across the country and who were involved in supporting everything from childcare when members had to attend meetings to career advice.
Wrapping up the forum, each panelist was asked to provide one word to define the facility of the future. The words chosen were resilient, connected, flexible, human, people-oriented, and resource—words that could easily be used to describe these panelists.
Disclaimer:
This article contains an unabridged, unofficial summary of regulators and industry panelists’ presentations and discussion during a panel dialogue at an ISPE conference that has not been vetted by any agency or organization. The responses are an informal and brief synopsis of the panel’s views and do not represent official guidance or policy of any agency or organization.
