Agenda

Mobilizing a Digital Engineering Program: Practitioner Viewpoint Over the past 2 years, Gilead has invested in multiple areas of Digital Engineering innovations: From large investments in Cloud-based applications, to a state-of-the-art Data Mesh, to 20+ advanced controls use cases that were deployed in production to accelerate scientific ambitions. This presentation reflects back on results, learnings, and lessons learned, and offers a practitioner playbook on how to start a digital innovation journey at scale. Leveraging use cases that applied AI/ML/large Language Models to engineering problems, this presentation also delves into emerging issues that need to be addressed in any organization’s innovation incubation journey.

Modern biotechnology starting with recombinant DNA (rDNA) technology and the manufacture of human insulin in 1982, is now 40+ years old. Since then, we have witnessed major research advances that led to monoclonal antibodies, synthetic peptides, and DNA and RNA based biopharmaceutical therapies. These advances were enabled by a rapid evolution of manufacturing processes from very cost-intensive bespoke or dedicated (product-specific) manufacturing facilities to common standardized & modular manufacturing platforms. We have also moved from biopharmaceutical products which started off as injectables in a glass vial to medicine now consisting of drug-delivery device combinations. With the advent of genetic medicine as a result of the Human Genome Project in the early 2000s, we are now witnessing a situation where modular clean room facilities next to hospital beds serve as today’s manufacturing platform, with the human body serving as the de facto medicine factory with DNA and RNA therapy. In the near future, we will witness an exponential ramp-up in innovation in areas ranging from chemical synthesis of biopharmaceuticals vs biosynthetic means, more cost-effective & scalable ways of enabling genetic medicines, improved ways of delivering DNA and RNA into cells as well as biopharmaceuticals transitioning from today’s injectables to orally ingestible medicine - all this will pave the way to further improve cost, access, and sustainability. In this seminar, I will share implications for ISPE engineers both by ways of research directions and education. I will also be sharing my lessons learned over ~ 25+ years at Eli Lilly, Cook Pharmica, Moderna, and to the present day at Convatec where my team and I are helping pioneer trusted medical solutions to improve the lives we touch.

Polyfluoroalkyl substances (PFAS) are called 'forever chemicals' due to their longevity in the environment. A number of health-related outcomes have resulted in varying levels of environmental legislation for this class of materials. For example, the European Chemicals Agency (ECHA) has proposed a sweeping ban on PFAS within the European Economic Area (EEA). The implications for bio/pharmaceutical manufacturing of the ban in the EU encompass virtually the entire ecosystem of materials related to bio/pharmaceutical manufacturing. The Global Material Qualification organization within Takeda is taking an agile, systematic approach to assessing the risk environment created by the proposed ban and developing different response scenarios for Takeda to ensure our ability to provide life-transforming products to patients. This presentation will provide examples from the different facets of the Global Material Qualification approach to address the emerging challenges of the proposed PFAS ban in the EEA and beyond.

The radiopharmaceutical field is rapidly transforming the treatment of life-threatening; however, this rapidly growing medical sector presents unique challenges and safety requirements in management and manufacturing, compared to other treatments. Radiopharmaceutical production necessitates highly specialized equipment and controlled environments equipped to safely store, prepare, fill, and package radioactive materials. Designing facilities to accommodate these critical processes demands a meticulous approach to safety, efficiency, and regulatory compliance. In addition, it is crucial for the design team to be embedded early in the process, with the client, as requirements vary from client to client and product to product. This dynamic session will explore essential considerations for creating a strategic framework that ensures the successful implementation of a radiopharmaceutical program. The owner and design team will share lessons learned and successes from designing RayzeBio's 63,000-square-foot manufacturing building in Indianapolis, IN. Attendees will leave the presentation armed with strategies and best practices for future building projects on their own campuses.

Climate change is the defining crisis of our time. The science is clear: we must commit to net zero GHG emissions across the value chain. The 2015 Paris Agreement aims to limit global warming to 'well below' 2°C, with efforts to cap the increase at 1.5°C. Failure to reduce GHG emissions could result in temperatures rising above 3°C by 2100, causing irreversible ecosystem damage. Average world temperatures have already risen by more than 1°C, leading to rising sea levels, heat waves, natural disasters, and ecosystem changes. Nearly 60% of the world's largest companies have announced decarbonization goals, but only 4% have complete, transparent plans. While AI and digital innovation dominate future workforce discussions, a climate revolution is also underway, requiring all employees to support corporate climate goals. This presentation focuses on technical solutions to reduce GHG emissions in biopharmaceutical manufacturing. Industry leaders will share decarbonization targets and plans, showcasing novel design solutions that address energy-intensive process steps or supporting components. Experts will discuss the rationale behind these targets, corporate climate commitments, and evolving employee expectations. By highlighting actionable insights, we aim to advance sustainability in biopharmaceutical manufacturing.

This presentation will explore the application of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) in the context of a continuous manufacturing facility for monoclonal antibodies. We will discuss the challenges and opportunities in adapting this standard to the unique requirements of continuous bioprocessing and how Just-Evotec Biologics has implemented this in constructing two mAb facilities. This presentation will provide valuable insights for biopharmaceutical professionals involved in facility design, quality assurance, and regulatory compliance. Attendees will gain a deeper understanding of how to leverage ASTM E2500 to enhance the efficiency and quality of continuous mAb manufacturing processes.

A review of the plastic waste generation in the biopharmaceutical industry:
- Focusing on using single-use technologies in bioprocessing.
- Discuss concerns on sustainability based on plastic waste streams.
- Review the scale of plastic waste produced
- Review a bioprocess modeling package that can estimate the plastic usage for typical monoclonal antibody production at varying scales
- Discuss fluid handling components, filters, and resins.
- Show worldwide monoclonal antibody estimated total annual tons per year for bioprocess-related plastic waste generated by the industry. 
- Inform sustainable practices within the biopharmaceutical industry and encourage the development of more sustainable disposable technologies.

Since adopting single-use technologies in biopharmaceutical manufacturing in the 1990s, there has been concern about the generated plastic waste streams.  Estimates for plastic waste based on production quantities provide the biopharmaceutical industry with methods to predict waste produced and establish more sustainable disposal methods as single-use technology products expand into the mainstream production of biologics.

See the future of pharmaceutical facilities for yourself in this virtual tour of Kindeva's Bridgeton, Missouri facility. Freshly completed in 2024, Kindeva's new world-class sterile fill-finish location includes more than 155,000 sq. ft. of dedicated aseptic operations space, two labs, two formulation suites, and approximately 11,000 square feet of fill suites. Conference attendees will get to explore the building while learning about the strategic decisions an integrated team had to make to have the facility designed, built, and running in just one year. The session will delve into the innovative use of phased packaging and modular construction techniques, which allowed for simultaneous design, offsite fabrication, and onsite assembly, significantly reducing the overall project timeline. This virtual tour and case study will offer valuable insights into the collaborative efforts and strategic planning that drove the success of the Kindeva project, setting a new benchmark for rapid, efficient, and innovative pharmaceutical facility construction.

Practically Applicable Measures to Save Energy in Cleanroom HVAC Following an overview of strategies for attaining an energy-efficient pharmaceutical cleanroom and the relevant ISO standards., 14644-4 and 16. The discussion presents measures to optimize energy consumption, presenting recent solutions already applied. These measures consider the advancements in equipment design, airflow control devices, and BMS.  Main topics include: Setting ambitious standards for max fan energy consumption. Cutting 50% off fan energy consumption in 2010 project compared to previous similar projects, cutting another 40 – 50% in 2024 project compared to 2010 project Setting hot water supply to max 45C and varying seasonally. Benefits in terms of heat recovery, use of heat pumps, etc, and the benign drawbacks Benefits and drawbacks of different media temperatures for sensible and latent cooling Lifecycle analysis of lower duct velocity – CO2 footprint related to installation and use BMS programming to optimize energy consumption HVAC redundancy as a means to achieve higher uptime and lower energy consumption A CFD study on optimal diffusor configuration Ring headers for supply and return flow – benefits and drawbacks

Since the definition of the ballroom concept was first introduced in 2013 via ISPE's Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities, the industry has looked for opportunities to further build in flexibility for bioprocessing and biomanufacturing into facility design, yet maintain a standard approach to facility layout options to allow faster delivery time without re-engineering of design approaches. This presentation will cover common industry challenges, considerations, and best practices in achieving a standard facility design approach, and how this can be applied to single-product, multi-product, or multi-modal manufacturing facilities, including a case study reference to the recent ISPE Facility of the Year Award winner Roche Genentech (South San Francisco Clinical Supply Centre) and their use of recent BioPhorum publications and initiatives to achieve this, as well as other industry standards and consortia works. The presentation will also include survey results (provided via BioPhorum) on the market need for, and perceived or anticipated operational and regulatory challenges surrounding, the implementation of a multi-modal manufacturing facility (e.g. closed systems usages, material transfer types, plant maturity, etc.) from a range of anonymized biomanufacturers.

As sustainability and green initiatives continue to gain momentum in the industry globally, the need to reduce the carbon footprint of new manufacturing facilities in order to meet new regulations, achieve green building certifications, and meet the sustainability goals of the owners is becoming more critical.  This is increasing the demand on suppliers in the facility construction value chain to provide disclosure of their product's cradle to grave environmental impact in compliance with the ISO 14025 standard for environmental declarations. Since cleanroom environments account for a notable footprint within new manufacturing facilities being constructed, the materials and products used to build these cleanroom environments can contribute significantly to the facilities' overall carbon footprint. Fortunately, there are certain cleanroom solutions providers within the industry leading the way in reducing the environmental impact of their products through innovation and a focused effort on limiting Scope 3 Emissions for their clients.  This presentation will provide an overview of the challenges suppliers face in reducing their impact and an approach that has been implemented by global cleanroom solutions provider utilizing Environmental Product Disclosures (EPDs).

The pharmaceutical sector is in a state of constant development, currently focusing on creating and building facilities that can support a flexible array of products (in terms of variety, quantities, and sizes). Additionally, there is a growing interest among some stakeholders to manage the entire process from clinical to commercial stages, including full lifecycle products, within a single location, as well as the co-location of various different product modalities. These trends indicate a requirement for facilities that are more adaptable, enabling manufacturing operations to be quickly relocated, retrofitted, or expanded with efficiency. This adaptability not only enhances operational efficiency but also allows companies to respond swiftly to market demands and regulatory changes, ultimately fostering innovation and reducing time-to-market for new therapies. Bristol Myers Squibb aimed to establish a global standard for a new agile manufacturing concept that would facilitate multi-modality manufacturing across different products, volumes, and scales, while also enhancing future capacity decisions and regulatory adaptability. BMS collaborated with PM Group to create a standardized design that would separate the Building Shell from the interior layout, allowing for rapid deployment at both existing sites and new locations globally. In line with the design approach, the team aimed to standardize technology platforms and shift away from "purpose-built" designs to develop generic Process Modality floorplates (modules). The team leveraged a significant portion of BMS’s current product pipeline as a benchmark to appropriately size process capabilities and technologies that would be included in Flex Modules. These modules were then designed to meet Launch capabilities while also being versatile enough to expand and accommodate Commercial Scale capacities in the future. A nimble strategy will allow BMS to build globally adaptable shell structures within their network, irrespective of product choices. This will enable swifter market entry, while also allowing ease of future repurposing. This presentation summarizes the design methodology employed to bring the innovative Agile Manufacturing Concept to fruition.

Solvent and Reagent In-Situ Reuse in Solid Phase Oligonucleotide Synthesis

The ‘Bannon Penfold’ approach to accommodating multiple modalities was first published in the ISPE Pharmaceutical Engineering Journal in November, 2022.  An approach and methodology that has since been widely adopted by the industry with all the benefits of a more structured, science and risk-based approach that also takes into consideration the relevant regulatory guidance.  The original authors and founders of the approach, Tom Bannon and Alf Penfold, would like to apply the approach to a series of very different ATMP modalities and demonstrate just how simple and effective the approach may be applied when combining different modalities.  An approach that will provide many benefits such as an earlier project delivery with a more flexible and robust solution.

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Reaching New Summits in Pharmaceutical Manufacturing with Pharma 4.0 and Digital Transformation

The pharmaceutical industry is facing a multitude of external challenges, including cost pressures from healthcare systems, such as the Inflation Reduction Act (IRA), patent cliffs, and changes in the global political landscape, exemplified by the BioSecure Act. Amidst these challenges, Pharma 4.0 is emerging as one of the paths to sustainably bringing innovation to patients. The ISPE's frameworks have supported and encouraged steps towards digitalization and outlined benefits and use cases. However, the pharma industry has been slow to change compared to other sectors. Already in 2021, the FDA was stating that "some industries are now well into Industry 3.0, but in many ways the pharmaceutical industry is still very much transitioning into it." With two-thirds of drug shortages historically still attributed to quality-related issues, the opportunities to continue the digitalization journey are plentiful.

Exploring the root causes, many companies are lost on the journey, either organizationally or technologically, with some unsure of where to start, others pursuing multiple pilot projects, and some finding that the technology journey is just the beginning of the transformation journey. Additionally, the industry faces a tension between decentralized, democratic, and duplicative organizing principles versus centralized, cumbersome kingdoms. 

Takeda has been on this journey for many years and has taken the challenges head-on. From the Facility of the Year (FOYA) awards for Singen and Linz awards in 2022 and 2024 to public commitments to sustainability Pharma 4.0, Takeda's approach has enabled the implementation of numerous technologies and new ways of working. As the industry faces an increasingly diverse portfolio and an ever-complex manufacturing landscape, Pharma 4.0 will be a key driver of growth to meet patients’ demands. We would like to explore some of the good practices we learned on our digital transformation journey.

Regulatory Speaker Invited

The new manufacturing paradigms in life sciences pose considerable challenges to the engineers who have to deal with automation and digitalization. For example, the operational flexibility required in biotech, the modules that make up the production processes in flow chemistry and the inefficiencies caused by the numerous manual operations in cell therapies. But what do these production sectors have in common? They consist of modules specialized in specific functionalities linked together to produce a specific product. Modules produced by different suppliers, often incompatible from a digitization point of view. For some years now, the concept of 'modular production' has been gaining ground, whereby production processes are subdivided into intelligent modules capable of communicating with each other in a standardized manner. These are combined with a software application capable of automatically recognizing the various modules and 'orchestrating' their operation according to a user-defined sequence. We call it “plug & produce”. To support this production concept, a standard called MTP - Module Type Package (VDI/VDE/NAMUR 2658) - has been developed and has proven its worth in recent years. The authors of this contribution are members of the Plug & Produce working group of the ISPE Pharma 4.0 CoP.  The presentation will introduce the advantages of this new approach based on the MTP standard by giving concrete examples of the application of modular automation in the life sciences field, contained within a concept paper that is currently being developed.

Annex 1 requires minimizing human intervention in critical areas such as fill and finish operations. Robot Telemanipulation allows a person to control robot arms from outside the sterile or hazardous environment to do things that are too hard or expensive to automate. On a daily basis, Robot Telemanipulation enables Robotic Surgery and bomb disposal. Robot Telemanipulation enables a world where operators can perform delicate tasks without stepping foot into sterile or hazardous environments. With stereo 3D vision and telemanipulation software, operators gain a lifelike view of the environment and wield precise control over robotic arms, mirroring the precision of surgeons in robotic surgery. But the benefits don't end there. Beyond minimizing human interaction, telemanipulation systems offer additional perks, including data recording and 3D video documentation of interventions. This not only enhances process transparency but also enables comprehensive analysis and optimization. Today, Pfizer is using Robot Telemanipulation to test use cases and pave the way for operational integration. Join us as Pfizer and SRI share insights into the best use cases for this transformative technology.

This abstract presents a best-in-class collaboration between one of the largest separation manufacturers in the world and Novo Nordisk A/S. This presentation will showcase the successful co-creation of filtration technology - used in the pulp/paper, wine, and juice industry – for use in API manufacturing. Results include operational savings, full process closure, and enhanced quality. The culmination of this collaborative effort will be presented at the ISPE Facility of the Future Conference, emphasizing the transformative impact of cross-industry innovation, particularly in meeting the stringent requirements of pharmaceutical Good Manufacturing Practice (GMP) standards. The close co-creation between Novo Nordisk A/S and the manufacturer has fast-forwarded the manufacturer's GMP understanding by decades, expanding the vendors supporting our industry. The presentation will spotlight the outcomes of this collaboration, including the innovative partnership highlighting the potential for potential, when we look to other industries for inspiration.

Driven by the new Annex 1 requirements the use of automation during the critical process of fill & finish is a current focus for the industry, especially the usage of robotics as a tool for automation which is referenced in the "Principles" Section of Annex 1. The target is to protect the product from potential extraneous sources of contamination such as personnel. The presentation will take a deep dive into the current usage of robotics within the pharmaceutical manufacturing environment and it will highlight things that need to be considered during the implementation of these technologies (e.g., first air requirements). After discussing the current usage of robotic technologies the presentation will focus on fully gloveless robotic technologies with the focus of removing the human from the most critical processes (e.g., setup of the filling path, environmental monitoring, etc.). The presentation will link technology with reference to regulatory guidance documents and it will give an outlook on how robotics can improve an overall contamination control strategy.

To accelerate greenfield projects, the necessary production processes must be developed quickly without compromising safety and risk management; however, due to their inherent complexity, the risks in the processes are often manifold and can only be identified with a considerable amount of time and resources - this delays the market launch of important drugs and is often associated with major corrections, as some process weaknesses remain unidentified, jeopardizing the entire commercialization process. The main reason for the high effort and error-prone nature of process design and risk assessment is that they have to be created largely manually. The presentation will introduce a novel process simulation approach that utilizes a generic database around so-called "process-frames" (process-microsteps) to develop data-driven recommendations for process design and autogenerated risk management insights with unprecedented accuracy. By linking the "process frames" with numerous production data, a self-learning software has been created that also identifies potential risks for new process ideas and helps to achieve robust process design and CCS more efficiently. The presentation presents a case study from Kindeva and shows how "Frame-by-Frame Risk Profiling" has significantly accelerated process design and risk management - both prerequisites for faster plant and operational readiness.

Innovation in Pharmaceutical Manufacturing Leveraging Digital Twins The presentation titled "Innovating in Pharmaceutical Manufacturing Leveraging Digital Twins" explores the transformative potential of Digital Twin technology in the pharmaceutical industry. It begins with an introduction to Digital Twins, defining them as real-time reconciliations between physical asset behavior and a simulation-based digital model. The session highlights the significant business challenges in pharmaceutical manufacturing, such as sub-optimal commissioning, operations, and maintenance processes, and positions Digital Twin technology as a game changer. The presentation differentiates between Equipment Digital Twins, which are detailed digital replicas of manufacturing lines, and Product Digital Twins, which simulate the fluidic filling process to optimize product characteristics. It outlines Sanofi's journey in adopting these technologies, emphasizing the benefits already realized, such as reduced downtime, improved production line capacity, and enhanced training and process optimization. The discussion extends to the broader impact of Digital Twins in pharma, including the reduction of product testing and engineering runs, and the potential to streamline product transfers to manufacturing lines. The session concludes with a call for collaboration among industry stakeholders, regulatory authorities, and academic institutions to fully unlock the potential of Digital Twin technologies in enhancing efficiency, quality, and compliance in pharmaceutical manufacturing.

When a Takeda Minneapolis mAbs facility was faced with a common biopharma challenge of production growth exceeding capabilities in an aging, maxed-out laboratory space, the team turned this challenge into an opportunity - a data-driven, digitalization-focused opportunity for an optimized, innovation-forward QC Laboratory of the Future. The team analyzed QC Lab conditions, constraints, and opportunities on how to efficiently support future production. People-Centered Innovation, Patient Focused Results drove the purpose of this project in future-proofing a lab space and truly elevating the site's landscape. This presentation explores how the team developed quantitative data for an optimal path forward. This case study will discuss how the team developed a compelling business case, leveraging a set of comprehensive studies using a tool kit of industrial engineering, digitalization, and strategic facility planning to inform key facility questions for early data-driven decision-making. These questions include whether reconfiguring, expanding, building new, or leasing new space is the best option, and which Pharma 4.0 technologies would best enable growth, empower people, and align with Takeda's digital manufacturing strategy. Hear the many ways this team examined the data, from process mapping, baseline capacity modeling, a lab-of-the-future analysis, equipment lifecycle considerations, and more.

Integral to time to market in the (bio)pharmaceutical industry, the need for enhanced functionality and compliance in manufacturing operations continues to grow rapidly. Biopharma companies are under intense pressure to bring progressively sophisticated production capacity online in ever-shorter timelines. This presentation will delve into the role that modular hardware and automation frameworks are increasingly playing in helping meet this need, in particular by enabling the implementation of sophisticated control strategies. We provide a detailed description of these frameworks and the symbiotic relationship between modularity and advanced control in today's biopharma environment. We present a detailed case study on the implementation of such a strategy in upstream bioprocessing (microbial fermentation), covering the orchestration of overall operations, the optimization of the production processes, and the impact on compliance given regulatory considerations. As we venture into the future of pharmaceutical production, this presentation addresses the accelerating modularity trend and the implications for industry.

In the face of energy shortages, rising prices, shorter time-to-market, and increasing competitive pressure, speed, flexibility, and maximum efficiency are more important than ever in the process industry. These goals can only be achieved through fully digital data management and seamless integration of digital tools over the complete lifecycle of a production plant. This presentation provides insights into how CSL Behring's new €400 million plasma fractionation plant in Marburg, Germany, was engineered and is operated using an integrated digital approach that employs highly accurate Digital Twins at each stage. The benefits are manifold: In the early phases, process alternatives were quantitatively compared, capacities estimated, or equipment sizes determined; in later phases, detailed workflows were developed, subsystems for cleaning, utilities, buffers, or resources were designed, process robustness under uncertainties ensured, optimal operating modes identified, automation and production planning developed, and commissioning supported. After commissioning, the Digital Twin was re-used in the new solution INOSIM Foresight for operations support. With accurate dynamic predictions, the solution supports the operating staff in all aspects of operation - whether through real-time planning of production, personnel, and resources, predicting and "combating" disruptions, optimal maintenance planning, efficient onboarding of new employees, and many other use cases.

The ISPE Facility of the Year Awards (FOYA) program celebrates cutting-edge pharmaceutical facilities that exemplify innovation, operational excellence, and a commitment to advancing patient care. Celebrating it’s 20th anniversary, this prestigious award honors facilities that demonstrate exceptional dedication to quality, efficiency, and cutting-edge technology, contributing significantly to the pharmaceutical industry and global health outcomes. In this session, we will introduce the 2025 FOYA Submission Finalists—projects that have met the FOYA program's rigorous standards and exemplify the industry's highest achievements. Presented by a select panel from the FOYA Judging Committee, this session provides attendees with an exclusive, first-look at these facilities from around the world.