In today’s pharmaceutical landscape, over 80% of R&D candidates in the global pipeline suffer from poor solubility, creating a significant challenge for effective drug delivery. To ensure that innovative medicines reach patients worldwide, advanced formulation and process technologies are necessary to overcome bioavailability issues, such as lipid-based systems and amorphous solid dispersions.
This webinar offers a special focus on hot melt extrusion (HME), providing a comprehensive guide to formulation and process development, equipment design and scale-up. Attendees will benefit from insights into how to make informed decisions when analyzing and choosing technology options for their processes.
The session provides practical instruction on setting up HME processes. Based on a case study, this webinar will also provide evidence regarding strategies that can significantly accelerate formulation and overall product development.
Register for this webinar to benefit from the combined perspectives from market leaders in the CDMO area and extrusion technologies, offering a holistic view on HME implementation from formulation to equipment design.
Speakers
Dr. Klaus Pollinger, Group Director Global Product Development, Aenova Group
Dr. Klaus Pollinger is a pharmacist by training and has a PhD in Pharmaceutical Technology. He has over 10 years of experience in the pharmaceutical industry with site and corporate roles in Pharmaceutical Development and Manufacturing Operations. In these functions, he has been extensively working on poorly soluble APIs.
Message Presenter
Dr. George Shlieout, Head of MS&T, Aenova Group
Dr. George Shlieout is a pharmacist who earned his PhD in Pharmaceutical Technology and Biopharmacy. He spent many years as a lecturer at Martin-Luther-University (Germany) and then began his career in the pharmaceutical industry, working in various companies and functions. His extensive experience in MS&T and development processes, combined with his deep expertise in advanced technology platforms such as hot melt extrusion and spray drying, underscores his expertise.
Message Presenter
Kathrin Reusch, Product Manager Pharma & Life Science, Leistritz Extrusionstechnik GmbH
Kathrin earned her Master’s and Bachelor of Science degrees in Food Technology at the University of Applied Science in Fulda, Germany. During her training years, she gained professional experience at Südzucker AG in Germany. Her professional emphasis there was on designing stability tests for tablets and characterizing tablet properties. Since 2014, Kathrin has been with Leistritz Extrusionstechnik GmbH as a Process Engineer for Pharma Extrusion. In 2019, she was appointed Product Manager for Pharma & Life Science Extrusion.
Message PresenterWho Should Attend?
This webinar will appeal to:
- R&D personnel such as Research Scientists (Drug Development), Drug Delivery Scientists, Excipient Scientists, Formulation Scientists/Engineers, Process Development Scientists/Engineers, Pre-Formulation Scientists, Clinical Research Associates, Pharmacologists
- Manufacturing personnel such as Manufacturing Science and Technology (MS&T) Scientists/Engineers, (Continuous) Manufacturing Engineers, Equipment Engineers, Production Supervisors, Production Managers, Manufacturing Operators, Manufacturing Technicians
- Project Managers/Process Transfer Personnel such as Project Managers (Formulation/Process Development), Material Scientists (Pharmaceuticals), Technical Transfer Specialists
- Quality Control Personnel such as Validation Engineers, QC Analysts, Quality Engineers
What You Will Learn
Attendees will gain insight into:
- Challenges in Pharma R&D: Overview of common formulation challenges in global pharmaceutical development, particularly for APIs with poor solubility and varying physicochemical properties
- The role of Hot Melt Extrusion (HME): Introduction to HME as a leading technology for improving solubility and bioavailability
- Considerations for Development and Scale-Up: Key considerations in pre-formulation, formulation development, process design and scale-up to commercial manufacturing
- Accelerating Time to Market: Practical guidance on how to design HME-based formulations and define critical process parameters to allow for rapid and right-first-time product development
Xtalks Partners
The Aenova Group
The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. As a one-stop shop, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes from pharmaceuticals to dietary supplements for human and animal health: solid, semi-solid and liquid, sterile and non-sterile, high and low dose, OEB 1 to 5 (Occupational Exposure Band). Approximately 4.000 employees at 14 sites in Europe and the USA contribute to Aenova’s success. Further information can be found at www.aenova-group.com.
Leistritz Extrusionstechnik GmbH
Leistritz is one of the leading companies in the field of extrusion technology. Since 1937 development, production and worldwide distribution of extruders and extrusion lines have been the main objectives of Leistritz Extrusion Technology. The company has sales and service branch offices in the main markets of Europe, the USA and Asia. The headquarters of Leistritz in Nuremberg, Germany, accommodate administration, development and production facilities as well as fully-equipped laboratories for process technology. Further laboratories for the development of formulations and products are at hand in Branchburg, NJ/US, Singapore and Taicang, China.
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