Press Release (ePRNews.com) - LONDON, England - Mar 21, 2017 - SMi Group are thrilled to welcome the expertise of Pierre Goldbach, Senior Group Leader in the department of Late-Stage Pharmaceutical and Processing Development at F. Hoffmann-La Roche Ltd, at the 5th annual conference on Pharmaceutical Freeze Drying Technology when it returns to Central London this May for its 5th annual show.
Dr Goldbach is currently working on the development of clinical and market formulations for Biologics. His presentation will discuss challenges in freeze drying high concentration biological formulations. Highlights will include insight into formulation approaches; the impact on cake appearance and protein stability; and approaches for reducing viscosity and optimizing reconstitution time.
In the run-up to his keynote address, SMi Group caught up Pierre to discuss current industry developments and his upcoming talk. From the answers given, it is apparent that a number of hurdles remain in the freeze drying of biologics. The full interview is available to read in the event download centre.
“I think scale-up is still one of the major challenges in lyophilisation, through the use of suitable PAT instruments can provide valuable tools for the successful scale-up/transfer to commercial sites. Mathematical modelling and QbD approaches will certainly help to overcome scale-up hurdles as well.”
“Due to the high doses required for some products it is needed to develop formulations with high protein concentration and high fill volume. These formulations may present some challenges such as high viscosity and long reconstitution time. One other challenge in the pharmaceutical industry is still the occurrence of cake melt-back/collapse which may result in high reject rate during visual inspection for certain products.”
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
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