Risk-Based Development to Support Process Qualification for Spray-Dried Dispersions

This webinar highlights Lonza’s commercial capabilities for creating amorphous solid dispersions using spray drying and informs on using a risk-based approach to support process qualification. How can it reduce risk, minimize material use during development, and help create robust processes ready for scale up? Register and learn more!

Register Free: https://www.pharmtech.com/pt_w/spray-dried-dispersions

Event Overview:

This webinar presents the commercial capabilities of the Lonza Small Molecules network and highlights a risk-based approach to support process qualification for amorphous solid dispersions made by spray drying. The speakers will discuss how process design and qualification fit into the process validation strategy, including how small-scale experiments can minimize drug substance usage and reduce risk to the process qualification stage. Elements of product design will be covered, including how taking a risk-based approach can help create robust processes with built-in manufacturing flexibility. Case studies will be presented to demonstrate in-process hold times at full scale.

Key Learning Objectives:

• Understand the commercial capabilities of Lonza Small Molecules.
• Identify key attributes of SDD formulations and learn how they are made.
• Learn how small-scale experiments can inform process qualification to reduce risk and material usage.

Who Should Attend:

• Pharmaceutical-industry directors
• Principal Investigators/CMC Leads
• Manufacturing and development engineers
• Technical Operations

Speakers:

Dory King
Principal Investigator, Associate Director CMC
Lonza Small Molecules

Dory King has worked at Lonza since 2002 in various roles supporting product development and GMP operations. She is an expert in modified release technologies, including osmotic tablet formulation, and bioavailability enhancement, and has a keen interest in process development, control strategies, and scale-up. Dory has led product development activities across many stages of the product lifecycle, from initial formulation selection through commercial filing, collaborating with a wide variety of pharmaceutical clients—from small university-based groups to teams within large pharmaceutical companies. Dory received a Bachelor of Science degree in chemical engineering from Cornell University.

Robert Hall
Director, MSAT
Lonza Small Molecules

Robert Hall is director of Manufacturing Science and Technology (MSAT) at Lonza Small Molecules in Bend, Oregon. He has held positions within product development and manufacturing during his 12 years with the site, advancing products across the drug product lifecycle. As director of MSAT, he is focused on late-stage process development and commercialization of new chemical entities across multiple technologies at the Bend GMP manufacturing facility. Robert holds degrees in chemical engineering (University of Texas) and biological engineering (Oregon State University).

Register Free: https://www.pharmtech.com/pt_w/spray-dried-dispersions