Upskilling the cell therapy manufacturing workforce: design, implementation, and evaluation of a massive open online course.

Cell therapies have gained prominence as a promising therapeutic modality for treating a range of diseases. Despite the recent clinical successes of cell therapy products, very few formal training programs exist for cell therapy manufacturing. To meet the demand for a well-trained workforce, we assembled a team of university researchers and industry professionals to develop an online course on the principles and practice of cell therapy manufacturing. The course covers the basic cell and systems physiology underlying cell therapy products, in addition to explaining end-to-end manufacturing from cell acquisition through to patient treatment, industrialization, and regulatory processes. As of September 2023, >10,000 learners have enrolled in the course, and >90% of respondents to the course exit survey indicated that they were "very likely" or "likely" to recommend the course to a peer. In this article, we discuss our experience in the collaborative design and implementation of the online course as well as lessons learned from quantitative and qualitative student feedback. We believe that this course can serve as a model for how academia and industry can collaborate to create innovative, scalable training programs to meet the demands of the modern biotechnology workforce.NEW & NOTEWORTHY We assembled a team of university researchers and industry professionals to develop an online course on the principles and practice of cell therapy manufacturing. We believe that this course can serve as a model for how academia and industry can collaborate to create innovative, scalable training programs to meet the demands of the modern biotechnology workforce.

Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods.

The LAL test has been the "gold standard" for endotoxin testing ever since it was first published as USP Chapter <85> in 1980. Since then, a number of innovative methods have been proposed to augment or replace the LAL test. However novel an alternate test method might be, we must be cognizant of our obligation to patient safety and heed compendial and compliance requirements to demonstrate results equivalence between any candidate (alternate) method and a predicate (compendial) test method. The following discussion explores the concepts of "equivalent", "different" and "not different", proposes the use of a two one sided test (TOST) for the demonstration of equivalence and provides examples of calculations using commercially available software to assess data on alternative endotoxins detection methods that have been published in the public domain1.