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 episode 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.
Handling Sterile Potent, Powders Inside a Single Use, Disposable Aseptic Isolator with Martyn Ryder
April 28th 2021During this podcast we shall be discussing how sterile potent powders are becoming more common in the bio-pharmaceutical industry and the challenges around handling these powders in conventional aseptic containment systems. Review the overarching benefits of compliant. single use isolator systems when handling sterile products and how they mitigate the risk associated with potent product batch manufacture.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Ensuring Compatibility of Pre-filled Syringes for Biopharmaceutical Application
August 13th 2024There is not a syringe solution that fits all challenges. In this Podcast, Enrico Barichello, Product Manager for Syringe Platform in Stevanato Group, and Alan Xu, Product Manager for Analytical Services in Stevanato Group's Technology Excellence Centers, discuss the best strategies to select the right pre-filled syringe (PFS) based on the key needs of combination products and illustrate how introducing analytical services from an early stage can help customers reach the market faster by avoiding costly product revalidations or reformulations. Don’t miss out on the opportunity to be part of the conversation driving the PFS industry forward.