What will this webinar address?
Jet milling is a well-established particle engineering technique for producing micronized powders with controlled particle size distribution and increased surface area. This makes them suitable for inhalation drug delivery. However, successful implementation of jet milling requires a robust Quality by Design (QbD) approach that ensures the critical quality attributes of the micronized particles are maintained throughout the process development.
This presentation will cover the principles and intricacies of the jet milling process. It will also highlight some of the challenges when micronizing for inhalation delivery, and give some possible solutions.
A case study will demonstrate a reliable process development strategy using a QbD approach for micronizing nilotinib, an API with potential for the treatment of severe chronic asthma. It will highlight the significance of implementing a QbD approach, and its benefits in process development.
Overall, this presentation aims to provide valuable insights into the jet milling process and QbD approach for inhalation drug delivery and their potential applications in drug development.
- This presentation aims to provide an in-depth understanding of the jet milling process, and the significance of implementing a Quality by Design approach.
- It will address the intricacies of developing micronization processes as a particle engineering technology for inhalation.
- A case study will be presented to illustrate a reliable process development strategy that ensures all quality-critical attributes are maintained.
Salvatore Mercuri serves as associate director of NPI & MSAT at Lonza’s site in Monteggio, Switzerland, which is Lonza’s European Center for Excellence for Particle Engineering, specializing in particle size control through micronization. Salvatore’s expertise includes the development of highly potent active pharmaceutical ingredients (HPAPIs) and the formulation of modified-release solid oral dosage forms. He joined Micro-Macinazione SA in 2013, prior to its acquisition by Lonza, and has held positions of increasing authority. Salvatore graduated with a degree in Industrial Pharmacy before earning his Ph.D. in Biopharmaceutics and Pharmacokinetics, both from the University of Parma. He completed postdoctoral work in the Department of Pharmacy at the University of Parma, focusing on modified-release dosage forms.
Pierre Vitaloni has more than 20 years experience in the pharma industry, mainly in the CDMO business. He trained as an electrical/mechanical engineer at a Paris engineering school, and gained an MBA degree from Thunderbird University in Arizona, US. Pierre then took a business development role at the Swiss CMO Helsinn Advanced Synthesis, where he worked on the company’s activities in the US, Canadian and Japanese markets. He moved to Lonza in 2020, where he now works in AM/BD at the Monteggio site, the company’s centre of excellence for micronization.
This webinar is brought to you by
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18th July, 2023
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4pm CET / 10am EST
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60 minutes
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Free
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