The importance of ensuring the stability, preservation and safety of biological products with lyophilisation is well-known, but still faces significant challenges.
Major issues including scaling-up, transferring technologies and results from the lab to major production, developing optimum formulations to speed up the freeze-drying cycles and ensuring homogeneity and compliance with key regulations remain unresolved. Consecutively implementing PAT and Quality-by-Design also raises a number of issues.
Pharma IQ’s 3rd Annual Lyophilization for Biologicals conference, will provide you with critical case studies and presentations from industry experts, to obtain solutions to your lyophilization problems. Highlights for 2013 include:
* The latest updates from the FDA first-hand! Mansoor Khan, Director, Division of Product Quality Research, gives us the FDA’s viewpoint on how to apply QbD for the lyophilization of monoclonal antibodies
* Tim McCoy, Genzyme, shows you how to successfully complete tech transfer for lyophilization cycles of parenteral drug products using heat and mass transfer models
* A focus on some of the recent technological developments in freeze-drying, including a presentation from Davide Fissore (Politecnico di Torino, Italy), on using soft-sensors to get QbD
For more information about sessions and the speaker line-up, simply download the event brochure at www.lyophilizationevent.com/brochure, email firstname.lastname@example.org or phone +44 (0) 207 036 1300.
To register your interest of attending the event, please visit www.lyophilizationevent.com/info.
Schützenstrasse 11, 80335 Munich