Press Room

Webinar - Development of Continuous Process API

Start
Wednesday, April 12, 2017 - 14:00
End
Wednesday, April 12, 2017 - 17:00
Location: online
Webinar - Development of Continuous Process API | Hovione
Speakers
Rudi Oliveira - Chemist, Continuous Manufacturing
Ruth Morais - Engineering, Continuous Manufacturing

Flow chemistry for the manufacturing of active pharmaceutical ingredients (APIs), which has been utilized in numerous industries for many decades, is attracting significant attention from the pharmaceutical industry. The main benefits associated continuous processing are reduced development time and operating costs, greater process safety when employing hazardous chemistries and improved process efficiencies, control and product quality. Hovione are focused on the development and implementation of capabilities for continuous processing. 

So, a practical methodology to perform continuous process development of API’s was built as a systematic workflow which involves several steps: idea screening to identify drivers and objectives, followed by a technical evaluation to select an appropriate technology and identify risks; passing through a process understanding and development phase at laboratory scale to assess the feasibility of converting batch process into a continuous one and ends up with scale-up, engineering studies and industrialization. 

Additionally, this workflow is embedded with a QbD rationale, resorting to mechanistic and statistical modelling to build process understanding and assist scale-up activities. Furthermore, kinetic models can be used along the process lifecycle to assist risk evaluation and process troubleshoot.

Learn more with this webinar, where practical cases that focus on how Hovione apply this workflow are presented.

 

What can you learn from this webinar?

  • Use of kinetic modeling to support continuous process development

  • Lessons learned from converting batch to continuous processes

  • How Hovione used structured workflow to perform continuous process development of APIs

 

Join Hovione's Webinar NOW!

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With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

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