The MIT Center for Biomedical Innovation (CBI) leads the Biomanufacturing (BioMAN) program, an initiative that joins leaders from industry, academia, and government to address collective challenges in biologics manufacturing by creating a pre-competitive environment in which stakeholders can share best practices and engage in collaborative work. Akron Biotech attended this year’s summit in Cambridge, MA on December 11th and 12th. This year’s BioMAN Summit focused on the challenge of driving innovation in cell and gene therapy manufacturing. It gathered speakers from cell and gene therapy companies, leading academic institutions, analytical tool developers, and regulatory authorities.
As Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) put it during his talk, the shift from biologics manufacturing to cell and gene therapy manufacturing implies an enormous leap in terms of product and process complexity. There is a great deal of work to be done to simplify and standardize the manufacturing process, as well as to define protocols for product testing and characterization. The very act of defining critical quality attributes (CQAs), and developing assays to measure an advanced therapy medical product (ATMP) across these dimensions remains complicated. Companies will need to resolve challenges in analytical testing and product characterization in order to develop safer and more efficacious products.
For example, cell population heterogeneity remains a significant challenge in creating standardized manufacturing processes; it is difficult to standardize a process that begins with a highly variable raw material. Professor Krystyn Van Vliet (MIT) presented research demonstrating that subpopulations of MSCs can be identified and sorted to achieve significantly increased therapeutic efficacy; MSC populations can be mechanoprimed by engineering the cell culture environment. Understanding the correlations and causes of such cell population heterogeneity can provide new CQAs. Other presenters discussed novel techniques for characterizing and sorting cells in a non-invasive manner, running functional characterization of cells in the manufacturing process, and conducting real-time microbial detection.
Akron Participated in the BioMAN Summit’s poster session, presenting work co-authored by Dr. Richard Harrison (Cell and Gene Therapy Catapult), Dr. Ezequiel Zylberberg (Akron Biotech), Simon Ellison (World Courier), and Dr. Bruce Levine (University of Pennsylvania), entitled “CAR-T Cell Therapy Manufacturing: Modelling the Effect of Offshore Production on Aggregate Cost of Goods.” This research is currently under review, and is part of a broader effort on the part of the authors to understand the primary cost drivers in the cell and gene therapy manufacturing process. To learn more about Akron’s initiatives to drive down cost of goods, especially cost of critical ancillary materials, please reach out and ask!
And of course, we wish you all a very happy new year! With your help, we contributed 500 trees to the California reforestation project through One Tree Planted. Here’s to more collaboration and growth in the new year!