Next-generation bioprocessing strategies to improve tech transfer
Tech transfer is a critical yet challenging element of drug development and manufacturing
Uploading the mind: digitizing process knowledge to improve the speed, quality and cost of tech transfer
Presented at BioProcess International Europe, by Marc Smith, Director Strategic Solutions at IDBS.
To address the tech transfer challenges that can delay or inhibit successful process scale-up, there is a need to rethink how the process description is controlled from the very start of process development, through process characterization and optimization and ultimately on to manufacturing.
We will explore how taking a holistic perspective can address key pain points, such as process standardization, design consistency, compliance and communication between R&D and manufacturing teams. This approach, facilitated by a digital data backbone and analytics engine that shares data and knowledge across the BioPharma lifecycle, helps to control the creation and development of the process description, automate experiment generation, facilitate structured experimental execution, integrate DoE, and by using industry-standard formats, streamline the transfer of the process description to manufacturing.
- Only by recording how the process and the product interact, and by removing the bias towards “success” data, can we begin to see the full benefits of AI and other advanced analytics for process optimization.
- The future of tech transfer is that there is no tech transfer. The entire process of tech transfer has already been defined throughout the drug development lifecycle.
- An innovative tech transfer approach can enable consistent and compliant processes, increase efficiency, reduce costs and revolutionize drug manufacturing in the pharmaceutical industry.
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Meet our speaker
Director, Strategic Solutions, IDBS
Marc is the Director of Strategic Solutions and is accountable for the development of the IDBS Polar BPLM and associated Solutions. Marc is an expert in laboratory and operational technology, laboratory informatics and system integration and leads a team of technological and domain experts committed to the development of the Polar Solutions. He has over 15 years of experience working in the pharmaceutical sector implementing and leading digital solutions and strategies. Before joining IDBS in 2021, he worked at Lonza Biologics and Angel Biotechnology. He holds a BSc (Hons) in Pharmacology from the University of Sunderland.