Vertex is a recognized leader in drug product continuous manufacturing, establishing one of the first end to end drug product continuous manufacturing equipment trains with real time release testing. Vertex’s journey into drug substance continuous manufacturing was initiated following our efforts on drug product and good progress has been made over the last three years.<br/>This presentation will outline Vertex’s strategy for implementing drug substance continuous manufacturing, which is a combination of in-house and outsourced work for R&D studies. In contrast to drug product, drug substance CM production relies exclusively on outsourced partners. This talk will focus primarily on a case study from R&D to production highlighting the advantages and challenges of scaling-up a flow chemistry process in the pharmaceutical industry, as well as the lessons learned.

Development of a continuous flow process from lab to production at Vertex Pharmaceuticals

2019 Fall National Meeting

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