Technology Transfer and Process Development of Danicopan to Enable Process Validation

Article
Drug substance
Process development
Tech transfer

Our recent article in Organic Process Research & Development delves into the technology transfer and process development of danicopan, an orally administered complement Factor D (FD) inhibitor. Danicopan is used in combination with C5 inhibitor therapy for treating paroxysmal nocturnal hemoglobinuria (PNH). The article provides an in-depth look at the collaboration between Alexion Pharmaceuticals and Cambrex, focusing on the challenges faced and strategies employed to meet expectations within a compressed timeline.

Outlining danicopan’s manufacturing processes, we trace its journey from early development to commercial manufacturing discussing key challenges, such as differences in process-validation-enabling studies, pandemic-related disruptions, and extensive experimental work required to ensure process validation and regulatory compliance. Our teams worked together to address and resolve process-related issues, such as high-temperature excursions and palladium removal issues. Taking a collaborative approach ensured that we understood any deviations and made appropriate adjustments to the process. This led to significant improvements, including increased yield, reduced process mass intensity, and shorter cycle times.

Key Highlights

  • Challenges faced during the technology transfer and process development of danicopan.
  • Importance of early and sustained collaboration during technology transfers, including expectation alignment, flexibility in manufacturing scale, and a focus on deliverables.
  • Overview of our results including significant process improvements leading to enhanced safety, increased yields, and shorter cycle times.

Read the entire Organic Process Research & Development article to learn more about Alexion’s successful technology transfer and process development of danicopan with Cambrex.

View the full article (via ACS Publications)