Process Analytical Technology for Biomanufacturing

Are you working in the pharmaceutical industry and are you looking for novel measurement techniques for collecting data? This compact three-day course surveys visionary aspects of modern and future GMP (Good Manufacturing Practice) methods. It includes QbD (Quality by Design) and PAT (Process Analytical Technology), as these technologies are gaining more and more ground in the pharmaceutical industry. However, the main focus is on models, data, and novel measurement techniques for collecting data. Data form the basis for model identification and validation, and novel sensors allow to significantly expand the number of variables that can be measured on-line or at-line on a bio manufacturing process. Different modelling frameworks, varying in terms of complexity, can be applied to such data. During this course, you will be introduced to: • Model supported process prediction, including computational fluid dynamics (CFD) methods for design space descriptions • The concept of digital twins for the potential use in batch or continuous production processes. • Virtual processes and laboratories for process understanding and operator training • Basic concepts of Artificial Intelligence (AI) and machine learning algorithms to transform data to actionable information. The course is intended for participants familiar with classical GMP procedures who want to learn about modern and future trends in QC methods.

At the end of this course, participants should be able to: • Describe novel digital methods and their potential use in a GMP environment • Identify opportunities for improved data collection on an existing process, including the use of novel measurement techniques • Interpret the results of CFD simulations for visualization of gradients and flow patterns • Describe basic concepts of software sensors, digital twins for unit operations and processes and identify the benefits of such model supported tools

Nongraded

The course is intended for participants familiar with classical GMP procedures who want to learn about modern and future trends in QC methods. The course material is perfect for new employees, support personnel from Quality Control and Quality Assurance, and vendors and suppliers providing equipment and services to the industry. The course covers all levels of education, including technicians, BSc and MSc. This course is intended for individuals with background, skills, and/or experience in the following areas: • Employees in biomanufacturing are currently working with GMP who want to get more familiar with current trends in the field • Scientists, engineers and technicians who are working with monitoring and controlling bio-based manufacturing processes • Vendors of auxiliary equipment for the bio-manufacturing industry • Employees handling data management aspects of biomanufacturing operations • Participants with a background in bio-based production hold a BSc, MSc or PhD degree. Prerequisites Participants must have a laptop/computer where it is possible to install software or already have an installed modern web. We assume participants have basic knowledge about the general principles of biomanufacturing and downstream operations. Participants are expected to bring a laptop to work with case study examples.