Navigating The Challenges Of Bringing Cell And Gene Therapies To Market
Cell and gene therapies are witnessing rapid advancements, but significant challenges remain for their commercialization due to regulatory hurdles, manufacturing barriers, high costs, and safety concerns. As of April 2024, the U.S. FDA has approved 37 cell and gene therapy products, primarily for oncology treatments. To ensure these therapies reach as many patients as possible, researchers need to consider business models early in the development process. Additionally, greater automation could enhance cell and gene therapy production, which currently relies on slower manual methods. The development of data collection tools has significantly influenced the market, with the current challenge being the management and formatting of this data to develop machine learning algorithms and incorporate AI. Explore how you can overcome barriers perpetuated by high costs and manufacturing process upgrades made necessary by market demand.
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