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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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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