“Unlock Flexibility and Digitalization with Modular Automation”
Rod Hoffman of AstraZeneca and Giuseppe Menin with COPA-DATA will introduce a successful plug-and-produce practice for modular automation. Traditional automation systems based on classical distributed control system (DCS) architectures are poorly adapted to the demands for high reconfigurability, modularity, and interoperability required by these new production paradigms. 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. This has been dubbed a plug-and-produce process. A standard called module type package (MTP) VDI/VDE/NAMUR 2658 has been developed to support this production concept and has proven its worth in recent years. This presentation will outline the benefits of this new approach based on the MTP standard.
“Directional Crossflow Filtration”
Cross-company collaboration can be challenging in the highly regulated pharmaceutical industry. Learn about Novo Nordisk’s efforts to collaborate with other manufacturers to improve their understanding of good manufacturing practices (GMP), subsequently expanding the vendors supporting our industry. This presentation will spotlight the outcomes of this collaboration, including the innovative partnership highlighting what is possible when one looks to other industries for inspiration.
“Accelerating Greenfield Project with AI-Driven Process”
The pharmaceutical industry has pursued risk management in all aspects for many years now. How can AI further improve the process to accelerate greenfield projects? The pharmaceutical industry is inherently complex; associated risks vary in nature and scope and can often only be identified with a considerable amount of time and resources. This can delay the market launch of important drugs and is often associated with major corrections, as some process weaknesses are difficult to identify, which can jeopardize the entire commercialization process.
Process design and risk assessments require an immense amount of effort and are often error-prone because they have traditionally needed to be developed manually. This presentation will introduce a novel simulated approach to process design that utilizes a generic database around process frames (essentially, 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 points, a self-learning software has been created which can identify potential risks for new process ideas and help achieve robust process design and contamination control strategies (CCS) more efficiently. The presentation will feature a case study from Kindeva Drug Delivery in collaboration with Innerspace GmbH that shows how frame-by-frame risk profiling has significantly accelerated process design and risk management—both of which are prerequisites for faster plant and operational readiness.
“The Journey to Future-Proofing a QC Lab”
When a Takeda monoclonal antibody therapy (mAbs) facility in Minneapolis, Minnesota, USA, 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.
The team sought to pursue a data-driven, digitalization-focused quality control (QC) laboratory of the future that was optimized and innovation-forward. They analyzed QC lab conditions, constraints, and opportunities on how to efficiently support future production. People-centered innovation and patient-focused results were at the forefront 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. Presenters 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. Learn about 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.
“Creating Value with Digital Twins for Batch Plants”
Digital twins have been implemented across various stages of pharmaceutical manufacturing. Presenters from CSL Behring, INOSIM, and ZETA USA Inc. will showcase a solution that supports the operating staff in all aspects of operation—including real-time planning of production, personnel, and resources, predicting and combating disruptions, optimal maintenance planning, and the efficient onboarding of new employees. 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 digitalized 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 every stage of the process. 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 were ensured, optimal operating modes were identified, automation and production planning were developed, and commissioning was supported. After commissioning, the digital twin was re-used in the new solution INOSIM Foresight for operations support.
Learn more about the 2025 ISPE Facilities of the Future Conference, taking place 27-28 January in San Francisco, California, USA.
