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Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Hilal Yamaner
Thomas Zahel, PhD
Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum to exchange ideas and address common challenges.

The biopharmaceutical industry is undergoing a seismic shift, driven by technological advances, evolving regulatory landscapes, and the emergence of breakthrough therapeutic modalities. Against this backdrop, the 2024 ISPE Biotechnology Conference in Boston, Massachusetts, USA, 17 – 18 June, is a key event for industry stakeholders to explore the critical role of data-driven approaches in biopharmaceutical technology transfer and process characterization.

2024 ISPE Biotechnology Conference

Track 3: Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization promises to be a cornerstone of the conference, offering a deep dive into the intricate interplay between data science and biopharmaceutical manufacturing. Attendees will have the unique opportunity to interact with leading experts and industry pioneers to gain insight into the latest trends, challenges, and solutions shaping the future of the field.

At the forefront of this track, Christoph Herwig, PhD, from Körber Pharma, will present "Good Practices to Achieve Data Quality and Data Maturity," which is expected to spark robust discussions. Herwig will emphasize the necessity for high data quality and integrity, addressing critical needs in process characterization and technology transfer. He will propose automated solutions to enhance data management, showcasing tools embedded in integrity-checked import routines. By automating data organization and analysis, Herwig posits that organizations can streamline tech transfer and validation activities, leading to proactive solutions that can address common data analysis hurdles. Through case studies, he will illustrate the transformative potential of digital twins and continuous improvement initiatives, driving optimized processes and accelerated innovation in biopharmaceutical manufacturing.


Digital Enablement of Clinical Bioprocessing

Building on Herwig's insights, GSK's Ted Webb will present "A Recipe-Centric Approach to Digital Technology Transfer,” outlining GSK's transition to this methodology to improve the efficiency of technology transfer in biopharmaceutical manufacturing. Webb will provide historical context from GSK's clinical manufacturing efforts and offer insights into their digital vision for technology transfer. He will share case studies that illustrate GSK's initiatives, including plant-specific efforts to improve data availability and cross-site engagement for digital technology transfer. In addition, Webb will discuss data modeling activities such as multivariate statistical process monitoring (MSPM) and model predictive control. The presentation will conclude with a forward-looking perspective on the importance of a sustainable data infrastructure.


Scott Tran, from Boehringer Ingelheim, will present "End-to-End Digital Twins as Life Cycle Companions." This innovative approach demonstrates knowledge transfer across the product life cycle, from process characterization to manufacturing. Tran will showcase how digital twins facilitate real-time monitoring, predictive analytics, and optimization, revolutionizing product lifecycle management. By creating virtual replicas of end-to-end manufacturing processes, invaluable insights are gained, enabling the prediction of intermediate and drug substance quality, along with optimized resource utilization. This approach illustrates the transformative potential of digital twins in driving efficiency, flexibility, and scalability, underpinned by a holistic control strategy and the interaction of process parameters.

Beyond the presentations, Track 3 will highlight the topics with interactive round table discussions, providing attendees with a dynamic forum to exchange ideas, share best practices, and address common challenges in biopharmaceutical tech transfer. From navigating regulatory expectations to optimizing manufacturing workflows, these discussions aim to foster collaboration and knowledge-sharing within the industry, empowering participants to drive innovation and success in their respective organizations.

In conclusion, Track 3 offers a comprehensive exploration of data-driven approaches to biopharmaceutical tech transfer, equipping attendees with the insights, tools, and strategies needed to navigate the complexities of modern manufacturing. Whether you're a seasoned professional or a newcomer to the field, don't miss this opportunity to be part of the conversation shaping the future of biopharmaceuticals.

Join ISPE in Boston, 17 – 18 June, for the 2024 ISPE Biotechnology Conference and embark on a journey of discovery, innovation, and collaboration. Register now to secure your spot and unlock the potential of data-driven biopharmaceutical manufacturing. ISPE looks forward to welcoming attendees to this transformative event!

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