White Paper

Continuous Flow Manufacturing Of Pharmaceutical Ingredients

Clinical Trials Laboratories In The Immuno-Oncology Setting

While batch process chemistry remains the standard in the pharmaceutical industry, a clear increase in continuous flow processes has emerged over the past decade thanks to the commercialization of preparative flow reactor units. In a recent survey questioning both CDMOs and major pharma companies, the majority anticipates that in the next 15 years, there will be a shift from batch to flow to up to 25% of the total portfolio.1 Moreover, with the release of the draft guidance “Quality Considerations for Continuous Manufacturing” in February 2019, the Food and Drug Administration (FDA) is determined to promote the implementation of continuous manufacturing processes with the main objective to improve product quality, which is the main underlying cause of drug shortages and recalls.2

In the future, a strong growth is anticipated for continuous flow manufacturing of active pharmaceutical ingredients as it offers a number of important advantages over traditional batch manufacturing in terms of quality, safety and sustainability of the overall process.

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