In-house Manufacture or External Sourcing of Gene Editing Reagents to Support the Growing Cell and Gene Therapy Business

Dr Ulrich Rümenapp, Senior Program Lead, Bayer AG

ABSTRACT: Beyond small molecule drugs and classical biopharmaceuticals like antibodies, cell and gene therapies are becoming more and more important to treat patients with severe diseases. Genome editing holds a great promise for cell-based therapies. Reliable manufacture and supply of the reagents used for gene editing - in the necessary quality - is essential. Depending on the application, gene editing reagents (GERs) may be starting materials or drug substances to be made following GMP principles or under full GMP. For development, clinical and commercial manufacture, companies need to decide between... Click here to Read More