QbD Approach to Small-Scale Studies to Enable Rapid Spray Drying Scale-Up

In this webinar, industry experts will discuss how QbD strategies can be applied in the systematic evaluation of small batches of spray-dried solid dispersions for oral delivery.

Register Free: https://www.pharmtech.com/pt_w/rapid-spray-drying

Event Overview:

Drug development is a complex journey that requires efficient manufacturing processes across different production volumes. Drug sponsors often face challenges like limited API quantities and tight development timelines, which can hinder the drug development process. In the quest to streamline the drug development process, the industry has increasingly adopted Quality by Design (QbD) principles to enhance efficiency and ensure quality.

In this webinar, industry experts will discuss how QbD strategies can be applied in the systematic evaluation of small batches of spray-dried solid dispersions for oral delivery. By adopting the QbD framework, drug sponsors can gain a deeper understanding of the formulation and process variables, ensuring that the developed spray-dried drug products meet predefined criteria for efficacy and safety. During the webinar, experts will also explain how this strategy has demonstrated its value by maximizing screening efficiency using limited API quantities within a shortened development timeline, effectively bridging the gap between early development and commercial-scale production of poorly soluble drugs. By attending this webinar, attendees will explore how the integration of QbD principles into small-scale spray drying studies can enable the rapid scale-up of spray drying processes.

Key Learning Objective:

• Understand the challenges of the spray drying process across different production scales
• Learn to apply QbD to de-risk the scale-up process, with a focus on developing spray-dried solid dispersions of poorly soluble drugs
• Gain practical knowledge on implementing small-scale DoE for process condition and process space mapping, and learn how these strategies can be integrated into a seamless transition from early development to full-scale spray drying

Who Should Attend:

• C-Suite
• R&D
• Product Development
• CMC
• Consultants
• Process Development
• Process Engineering

Speakers:

Llira McEachern
Engineer- Spray Drying Center of Excellence
Catalent

Llira McEachern is an engineer in Catalent’s Spray Drying Center of Excellence. In this role, she serves as a technical subject matter expert on spray drying programs and drives innovation and continuous improvement within the technology. She has experience with product and process development as well as technology transfer of pharmaceutical spray dried products ranging from pre-clinical to commercialization. She holds a Bachelor's degree in Chemical Engineering from Bucknell University.

Ian Kemp
Independent Consultant

Ian Kemp was a Scientific Leader at Glaxo SmithKline (GSK) for 13 years. Previously, he was in charge of drying for the Separation Processes Service (SPS) Consortium and Aspen Technology at the Harwell Research Centre in Oxfordshire. His specialist areas include spray and fluidised bed drying, dryer selection, design, scale-up and troubleshooting, and solids processing, particularly of pharmaceuticals, with over 50 published papers, articles and book chapters. He is a co-author of the Drying section of Perry’s Chemical Engineers Handbook. He has a Masters degree in Chemical Engineering from Cambridge University and is a Fellow of the Institution of Chemical Engineers. He has also researched and consulted on energy and carbon footprint reduction in process plants by pinch analysis, and is the lead author of a textbook on this subject.

Register Free: https://www.pharmtech.com/pt_w/rapid-spray-drying