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The development of emerging therapies poses unique manufacturing and formulation challenges for drug developers as candidates like cell and gene therapies advance through the pipeline.
As precision medicines garner increasing attention, drug makers have intensified their efforts to bring emerging therapies such as cell and gene therapies to market. This article gives an overview of cell/gene therapies in the making and explores the challenges biomanufacturers face in developing and manufacturing such inherently complex molecules. Unlike traditional small-molecule drugs and conventional antibody-based biologics, the roadblocks to developing and manufacturing cell and gene therapies can get complicated because of their molecular complexity and the fact that their mechanisms of action are not fully understood.
BioPharm International eBook: Development Strategies for Emerging Therapies
When referring to this article, please cite it as F. Mirasol, "Overcoming Hurdles in Emerging Therapy Development, " BioPharm International Development Strategies for Emerging Therapies eBook (September 2017).