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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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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Continuous Tableting and the Road to Global Adoption

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