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Road Mapping Digital Transformation in the Biopharmaceutical Industry

Prudence Edwards
Stephan Huelber
Road Mapping Digital Transformation in the Biopharmaceutical Industry

The advantages that come with a fully digitalized plant for manufacturing biopharmaceuticals are well documented and showcased throughout the biopharmaceutical industry and will be a featured topic during the 2023 ISPE Biotechnology Conference. Greenfield facilities that have been the first to embrace the tools of Pharma 4.0 (Industry 4.0, or the “Smart Factory”, as applied to the Pharmaceutical Industry) have reaped the benefits of data connectivity – including improved quality, productivity, and profitability.

However, for many organisations and facilities, being sold the advantages of digital twins, real-time predictive analytics, advanced robotics, and artificial intelligence, can feel like hearing a distant pipe dream. The day-to-day reality for many working in the industry is reliance on a paper-based record system, with great reluctance to move away from its familiarity and simplicity. Indeed, the highly regulated nature of the pharmaceutical industry has made the adoption of digital technologies significantly more complex. Even when digital tools are introduced the experience isn’t always smooth, as it can be even more challenging to exist in a hybrid digital/paper world. The benefits gained from digitalisation are hard to envision when interim measures include scanning handwritten Batch Records as digital batch records are “too hard” to implement or having digital records printed out just to have a paper copy stored in an archive. Considering this, the substantial financial investment requires a strong value proposition and a compelling strategic vision of the “end goal” of digital transformation.

2023 ISPE Biotechnology Conference

In these situations, digitalisation is best described as a journey, requiring much more than investing in data infrastructure, digital tools, and robotics. The digital transformation track of the 2023 ISPE Biotechnology Conference aims to explore all aspects of this journey, providing case studies and tools for attendees to feel confident in taking the next step down the road of digitalisation, no matter where their starting point may be.

To this end, ISPE has collaborated with Biophorum to present their Digital Technology Roadmap, which builds upon the Digital Plant Maturity Model, to set out challenges and identify the key enablers for organisations to unlock the potential of digitalization. Members of the Biophorum Technology Roadmapping and IT groups will share examples of where they are collaborating, and concrete examples of scalable solutions. These solutions enable progress for the industry as a whole, with considerations for all aspects of development from raw material to the final product.

One of the key challenges for any facility aiming for full connectivity is identifying and removing data silos. Most often, critical data resides in silos that are unmined or lack integration. A presentation from Robin Blankenbaker, Lifesciences Industry Lead at Siemens Digital Industries Software, will demonstrate a digital thread of data sources from R&D through commercial manufacturing. The digital thread view will provide attendees with a roadmap template they could use to initiate their digital transformation assessment. A potential future state will be shown to give attendees insight into a reality where standards, specifications, and batch data are connected. Through case studies, attendees will see the benefits to be gained from focusing on digital threads as they embark on their transformation journey.

The digitalisation journey is more than implementing systems to increase connectivity; it is a holistic process that increases visibility and transparency while enabling predictive and adaptive responses to real-time events on-site and throughout the supply chain. Mark Proctor, Senior Director, Site Operations at AstraZeneca will present a range of topics across key elements of the biopharmaceutical supply eco-system, illustrated with in-use cases and important lessons learned along the way. Core to the digital journey is concepts of the Minimum Viable Product (MVP), lighthouse teams, and quick scalability to deliver lost cost / no cost solutions that maximise the original return on investment.

Digitalisation would not be possible without the adoption of Artificial Intelligence (AI) and machine learning, the latter of which requires large amounts of data to build mathematical models (i.e., algorithms) to make predictions or decisions. The use of machine learning technology in a regulated industry raises concerns about product quality and patient safety, particularly when the technology is making decisions to automate processes. Michele Cianchini (Head of Quality Services & Improvement, Takeda) and Danilo Neri (Vice President Operations – Partner, PQE Group) will present a solution for automated trend analysis, which has been designed and implemented to allow the automatic evaluation of environmental trends with data acquired from a LIMS (Laboratory Information Management System) database. The presentation will describe the Life cycle implemented for the development, release, and maintenance of the Machine Learning algorithm.

Another technology synonymous with digitalisation is the digital twin, a virtual twin of the process built off real-time data. End-to-end digital twins of the manufacturing process are increasingly important tools for process development and characterization. In the past, companies employed Design of Experiments (DoE) to individually characterize each unit operation of the manufacturing process, without considering interactions between multiple unit operations. Thomas Zahel, Head of Innovation at Korber Pharma Austria GmbH, will present how end-to-end process models can be used as a self-learning recommendation system to suggest which runs should be planned to explore the relationship between CPPs and CQAs and to study the interaction between unit operations. A simulation study will be presented that shows that this digital twin can save more than 50% of the experiments for a typical process characterization study. This will open new possibilities in experimental planning, thereby substantially reducing experimental costs and time-to-market.

The track leaders for the Road Mapping Digital Transformation in the Biotech industry, and the 2023 ISPE Biotechnology Conference Program Committee, look forward to your participation in the conference. We hope these presentations will inspire the next steps in your organisation’s digitalisation journey.

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