Dr. Mattia Cassanelli

Day 1: Wednesday, 12 February 2020

CASE STUDY: Development of a lyophilised protein product using a QbD approach.

The presentation will describe a case study about the product and process development of a freeze dried protein product. The different phases from formulation to cycle optimisation and technology transfer will be covered, highlighting challenges and commercial benefits.

• Case study: lyophilised protein product
• Pre- and post- product characterisation
• QbD approach

Day 1: Thursday, 29 July 2021

CASE STUDY: A 2020 hindsight look at how COVID-19 has affected the freeze drying industry and what we have learned from it.

• Main challenges in 2020 seen from the eyes of a CDMO
• Development and manufacturing of PCR assay in lyocakes and lyobeads
• Development of lyo candidate vaccines
• Development of lyo blood products

Day 2: Friday, 30 July 2021

WORKSHOP: Role and measurement of mechanical properties in lyobeads technology.

The use of Lyobeads is becoming more popular within the Lyophilisation industry, due to their size and structure it is extremely important to understand the strength of the product and sustainability for their use. Utilising the MicroPress Mechanical Property Analyser, tests can be carried out on the Stress and Strain of the final product.

• Lyobead technology
• Uses of Lyobeads
• How to determine the strength of your Lyobead
• What can influence weakness within the Lyobead

Day 1: Thursday, 16 February 2023

CASE STUDY: The use of wireless temperature probes to understand heat transfer patterns in primary drying.

• Present examples of similarities and differences in data from wireless and wired probes
• Discuss shelf mapping data obtained using wireless probes in empty and loaded lyophilisers
• Highlight how accuracy of probe placement enables heat transfer patterns to be established with greater confidence
• Demonstrate how wireless probe data from different cycles can be applied to the calculation of Kv for a series of containers