Lyophilization (freeze drying) is used in biomanufacturing processes to remove solvent from drug products and improve stability. In this two-day hands-on course, you will learn the principles of biopharmaceutical lyophilization, process development, and dried product analysis.

In lectures and hands-on lab sessions, you will learn basic drying principles about how process inputs such as cycle temperature, time, formulation, and other factors influence final product quality attributes. Gain experience in the operation of laboratory scale lyophilization (SP VirTis Genesis) equipment. Using differential scanning calorimetry (DSC) and freeze dry microscopy (FDM), you will learn to determine critical product temperatures such as glass transition and collapse temperature which are key to designing a successful drying cycle. Moisture content and water activity of lyophilized products will be measured with Karl Fischer titration and tunable diode laser absorption spectroscopy (TDLAS) headspace analysis. Additional analytical techniques covered include visual inspection, reconstitution, and particulate analysis.

This course can be paired with Essentials of Spray Drying and Powder Analysis for a complimentary overview of additional drying techniques.

June 15 – 16, 2027

$1,975 registration fee

Register

Attend and you will learn 

• Basic principles of lyophilization
• To identify how drying process parameters affect the final dried product
• To properly characterize critical material temperatures using differential scanning calorimetry and freeze-dry microscopy
• To evaluate final product quality using multiple analytical techniques

Schedule

Day 1	Lectures • Biomanufacturing Drying Technologies • Introduction to Lyophilization • Freezing • Primary Drying • Secondary Drying • Material Characterization Lab Activities • Differential Scanning Calorimetry (DSC) • Freeze-Drying Microscopy (FDM)
Day 2	Lecture • Lyophilization formulation Lab Activities • Sample Thief • Headspace Analysis • Visual Inspection • Reconstitution and Micro-Flow Imaging • Coulometric Karl Fischer Titration (cKF) • Scanning Electron Microscope (SEM)
	*Subject to change

Who should attend

Anyone new to biopharmaceutical drying technologies and dried product quality analysis or with interest in advancing their understanding of the topic. This course is suitable for a wide audience including those in manufacturing, process development, research, sales, marketing, or managerial roles.

Instructors

• Danny Schmitt
• Sara Siegel, Ph. D.
• John van Zanten, Ph.D.