Scalability and Robustness of Freeze-Drying Cycles and Formulations
13th - 14th May, 2024
Cambridge, UK
Seminar overview
Biopharma Group is hosting a 2-day freeze drying seminar at the University of Cambridge covering topics including pre-lyo characterisation, equipment control, PAT, QbD, DoE, post-lyo handling and packaging challenges, and product analysis.
During the seminar we will also demonstrate two of our analytical instruments MicroPress and Lyostat5, as well as a benchtop freeze dryer Advantage Pro from SP Scientific.
Scalability and Robustness of Freeze-Drying Cycles and Formulations
Register to attend!
Sign up for the seminar now, number of spots are limited!
Introduce our experts
Kevin Ward
Director of R&D at Biopharma Group
Marta Schiano Moriello
Lyo, Fill & Finish Equipment Sales Manager
Stephen Jones
Freeze Dryers Sales Executive
Ian Blackham
Cryo Products & Analytical Instruments Business Development Executive
Micropress hands-on
We are offering our delegates a unique opportunity to bring product samples with them, as long as they are deemed safe to be handled (MSDS requested), to be tested with the MicroPress - an analytical instrument developed by Biopharma Group which enables you to determine the mechanical properties of the lyophilised cake.
Send your MSDS beforehand or bring it with you to the venue.
Seminar Timetable:
Day 1
Session 1: Welcome and Introduction
• Applications and challenges of freeze drying across pharma, vaccine and diagnostics sectors
• Input variables and output parameters for a freeze-dried product
• Repeatability vs. Robustness
Session 2: Demonstration of MicroPress, Lyostat5 and the Advantage Pro benchtop freeze dryer
• MicroPress hands-on,
• Advantage Pro and Lyostat5 demonstration,
Session 3: Formulation Design and Characterisation
• The effect of formulation ingredients on freeze-drying behaviour and critical temperature,
• Using Design of Experiments (DoE) in Formulation Development
• Primary and secondary packaging – influence on formulation and vice versa
Session 4: Understanding and Monitoring the Freeze-Drying Process
• Monitoring the equipment parameters (temperature, pressure)
• Individual Sample Measurement methods
• Global Batch Measurement methods
*Lunch and refreshments included
Day 2
Session 5: Defining and Analysing Critical Quality Attributes of the Product
• What are the critical aspects of the product?
• Taking a risk-based approach
• Quantitative and Qualitative assessments
Session 6: Cycle Robustness Testing
• Traditional approach to robustness testing
• Building in robustness using a QbD approach
• Reducing levels of uncertainty in product quality
Session 7: Course Summary
• Case studies and work examples
• Take-home messages
*Lunch and refreshments included
Register to attend!
Sign up for the seminar now, number of spots are limited!