Due to run on 22nd January 2014, the webinar entitled ’Secondary Drying Optimization for Proteinaceous Drug Formula’ is chaired by Lisa M Hardwick from Baxter Biopharma Solutions.
This free webinar focuses on how and why the secondary drying phase of a lyophilisation cycle can be critical for protein-containing products.
The webinar will utilise case studies to describe methods to determine acceptable ramp rates and shelf temperatures for the freeze dry cycle, as well as the optimal residual water content for the finished product.
Leading international lyophilsation expert - Dr Henning Gieseler is the presenter for the 20th February 2014 Lyolearn webinar entitled ‘Principles of Formulation Design for Pharmaceutical Freeze Drying - The Art of Cooking”.
Formulating an active pharmaceutical ingredient (API), in particular a biologic, is an integral step in drug development.
In freeze-drying, this step may significantly influence stability of the complex molecular structure during both the process and long-term storage.
The selection of appropriate excipients in type and concentration seems to be complex for those new to the subject, and might at some point trigger a déjà vu experience related to “cooking” where one may instantly feel that it is more “art” than actual “science”.
The webinar is designed to provide a first introduction to excipients frequently used for formulation design of (bio) pharmaceuticals, including their role as individual excipient and within the mixture.
It further highlights the relevance of their physicochemical behaviour for API’s in-process and long-term stability.
Specific topics to be covered include: key requirements for pharmaceutical formulation stabilisation, how to select appropriate excipients during formulation work, the classes of excipients most often used for freeze dried drugs and the physicochemical behaviour of crystalline/amorphous materials.
Dr Gieseler uses case studies from already approved market formulations to illustrate this informative webinar.
To learn more about or register for any of SP Scientific’s programme of webinars, please visit: http://www.spscientific.com/Webinars/
