Innovative Approaches for Selecting and Optimizing Versatile Chemically Defined Media
Driving the Successful Development and Production of Combination Biotherapies
A presentation by Robert Newman, PhD, CSO, FUJIFILM Irvine Scientific
At the 2021 Multi-Functional Cell Therapies (MFCT) conference, Robert Newman, PhD, CSO, FUJIFILM Irvine Scientific, presented innovative approaches that his R&D team use to select and optimize chemically defined media, and how these efforts drive the successful development and production of combination biotherapies.
Newman began the presentation by recalling the early days of the COVID-19 pandemic, when R&D received numerous requests from large biopharmaceutical customers for media to use in the development of new vaccines and therapies against the disease. FUJIFILM Irvine Scientific was prepared with sophisticated technology and capabilities to deliver the wide range of customer support needed - including media and process optimization for T cells, CHO, and HEK 293.
Newman also discussed the multiple technology platforms and development approaches that FUJIFILM Irvine Scientific uses including Rational Culture Media Design, Design of Experiment, and Multivariate Data Analysis. Case studies for T Cell, CHO, and HEK293 media were then examined, followed by a discussion of the media development paths that manufacturers can utilize to achieve similar results. The Media Survey Panel, Media Development and Optimization, and Express Media Service options available to test the feasibility of a formula before cGMP manufacturing were reviewed; as well as packaging, regulatory concerns, and the importance of raw materials in media manufacturing.
The presentation closed with the scalable media platform used by FUJIFILM Irvine Scientific to generate a predictive model of how a medium will perform at full scale of manufacturing while still in the early stages of development. Media characterization used to develop media, and the importance of analyzing the component performance were also discussed.