“We are currently using several different types of bioreactors for scale-up culture of mesenchymal stromal cells that are covered in this course. In addition, we are identifying early critical quality attributes to improve quality of the cells produced in these bioreactors.”

“This course was designed, developed and is taught by individuals with years of experience in the field of cellular therapy. It provides practical information about regulatory and ethical issues surrounding the development of these products worldwide including a discussion of the unique challenges of preparing and implementing clinical trials in the cellular therapy space. It is designed to be interactive with the intention of responding to the questions and challenges of the individual learners. I wish a similar course had been available when I joined the field.”

“This course will help learners understand that quality by design means designing a robust process that yields high quality product by gaining a deeper understanding of your process and assays and identifying and quantifying the parameters that most greatly affect product attributes.”

“The audience will learn the concept of a QbD-based automated cell manufacturing system with in-process monitoring by comparing it to a conventional pre-programmed robot-based cell manufacturing system without in-process monitoring. QbD-based manufacturing data will be digitized, allowing the entire manufacturing process to be visualized along with relevant QC data, helping to define manufacturing-related CQAs and the seamless development of the product throughout its lifecycle, which sometimes requires drastic process changes when moving from lab scale to clinical or commercial manufacturing.”

“Shin Kawamata provides an excellent presentation of Quality by Design principles specific to human pluripotent stem cell bioprocessing and manufacturing giving a unique perspective from Japan.”

“The lecture covers emerging manufacturing technologies such as digital twins and simulations for real-time decision support, offering a clear understanding of cell therapy supply chain performance, cost, and risk. Understanding these technologies is crucial for learners as they provide insights into enhancing patient outcomes and meeting the increasing demand for personalized healthcare solutions.”

“For students interested in learning from industry leading experts about the real-world problems and solutions related to Cell Therapy and Tissue Engineering, this course is a must.”

“The course breaks down key CPPs in microcarrier bioprocessing and why optimization before scale-up prevents costly failures.”

“All automation does not require the same level of complexity to be successful. During this course, we will cover the differences between automation techniques that range from fixed automation to fully adaptive automation and will provide examples of each class of automation. From these learning objectives, the learners will be able to understand which automation techniques are appropriate for their particular automation problem. We will also cover novel sensing, planning, and control for bioreactor systems. This will provide learners with a glimpse of the future and highlight active areas of research in the automation field.”