Analyse the new technologies and frameworks which will help optimise your freeze-dry process, and
improve scale-up, stability, and homogeneity.
60% of all biologics are currently being lyophilized – a figure that is only going to rise in the coming years. Critically important to ensure the stability, preservation and safety of biological products, this $1.3 billion industry faces significant challenges.
Major issues remain unresolved 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. Implementing PAT and QbD approaches at the same time as these challenges 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, and the opportunity to interact with fellow industry professionals and academics 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
NEW Scale-up Focus Morning, offering you:
- An in-depth look at the most prominent challenge you face with your lyophilization process – we have experts from Baxter Biopharma, MedImmune and Bavarian Nordic presenting their case studies and advice on how to overcome this issue
- Pitch your questions to these industry leaders in our special scale-up Q&A panel discussion – get the answers to your scale-up problems!