Lyophilization Process Development Workshop
SKU:LYO-2026A
Lyophilization Process Development Workshop: October 6–8, 2026
This intensive 2½-day workshop combines expert-led lectures with hands-on laboratory experience to demonstrate how lyophilization cycles are designed and how process decisions are driven by the thermal behavior of a formulation.
Working in collaborative groups, participants will analyze formulations containing common pharmaceutical excipients and develop a primary drying design space using heat flux data. Throughout the workshop, attendees will generate and interpret data using industry-standard thermal analysis and freeze-drying instrumentation.
While the core case studies focus on pharmaceutical freeze-drying, the principles, methodologies, and discussions apply broadly across multiple industries. Previous participants have come from:
- Pharmaceutical development and manufacturing
- Food science and preservation
- Diagnostic and medical technologies
- Tissue and biologic preservation
You will learn how to:
- Characterize formulation thermal properties
- Interpret DSC and freeze-dry microscopy data
- Develop a primary drying design space
- Design and optimize lyophilization cycles
- Evaluate product quality and residual moisture
- Analyze in-process drying data
- Apply freeze-drying principles to real-world products and processes
Workshop Activities & Instrumentation
During the workshop, participants will gain hands-on experience with:
- Mettler Toledo Differential Scanning Calorimetry (DSC) for thermal characterization
- McCrone Freeze-Dry Microscopy (FDM) for observing collapse temperature
- Millrock micro Freeze Dryers for cycle development and testing
- Residual Moisture Analysis using the Ametek Brookfield Computrac Vapor Pro XL
Resources
- Manual
- Millrock MicroFD Development freeze dryer
- McCrone Freeze Dry Microscope System
- Ametek Brookfield Computrac Vapor Pro XL
- Mettler DSC
- Hitachi TM4000Plus III Tabletop SEM
Lunch will be provided.
Workshop will take place at The McCrone Group, 850 Pasquinelli Drive, Westmont, IL 60559.
QUESTIONS? Contact Us!
$3500.00
Greg Sacha, Ph.D. is a professional in research and development with 25+ years of experience in the pharmaceutical industry. Dr. Sacha has expertise in formulation and process development of sterile products with special interests in large molecules and lyophilization (freeze-drying). He holds several patents for lyophilized formulations that are currently marketed. and has been extensively published in the field of parenteral products.
Dr. Sacha earned a B.S. in pharmacy from Butler University in 1993, and a Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1999.
- Characterize formulations using Mettler Toledo DSC
- Observe collapse and drying behavior with McCrone freeze-dry microscopy
- Collect thermal data needed for process design
- Develop an initial lyophilization strategy
- Freeze-dry samples using Millrock MicroFD Freeze Dryers
- Developing a lyophilization cycle based on experimental data
- Performing in-process testing during drying
- Evaluating cake appearance and product quality
- Measuring residual moisture with the Brookfield Computrac Vapor Pro XL
- Using heat flux data to construct a primary drying design space and evaluate process performance
- Refining process parameters based on analytical results
- Collaborating with fellow participants and industry experts
- Analysis and comparison of in-process drying data
- Review of cycle performance and product outcomes
- End-product testing considerations
- Manufacturing and scale-up discussions
- Research and production freeze-drying equipment
- Open discussion with lyophilization experts
Speak to a Scientist
McCrone Group's analytical scientists are available to answer your questions. Have a project you'd like to discuss? Give us a call or email us!