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Comparability for Biologics is a case-study rich two-day conference to enable you to work out an optimal characterisation protocol for your product after process change and to manage a cost-effective CMC regulatory compliance strategy. It will present state-of-the-art analytical methodology for aggregates, product and process related impurities and glycosylation, and further talks on bioassays for potency, binding and immunogenicity. Industry experts will also present their experiences with incorporating non-clinical and pre-clinical studies into a comparability programme.
Regulatory authorities from the US and EU and from industry will update you on regulatory requirements, including new guidelines and new concepts such as Design Space and Quality by Design, and be on hand for questions to enable you to learn how these new developments impact on your concern.
This case-driven 2-day event will enable you to:
v Develop a characterisation protocol for comparable products and biosimilars
v Discover how the leaders in the field apply analytical technologies
v Get expert advice on functional assays including immunogenicity
v Find out how to characterise aggregates and product and process related impurities
v Learn about pre-clinical and clinical comparability protocols
v Find out how glycosylation impacts on your product and about glycan mapping
v Hear comparability case studies dealing with change of cell line, of scale, of site of manufacture, of formulation and more
v Find out about new regulatory developments from the European and US regulators and hear from the industry how they deal with this.
v Discover how your concern can benefit from Quality by Design
50% Discount for Academics and Start-Up Biotech Companies:
Speak to Simon Lau for more details +44 (0)20 7017 7165
“An in-depth look at what needs to be assessed for comparability of biologics touching on the current hot topics of aggregation and immunogenicity.”
MedImmune UK, (Formerly Cambridge Antibody Technology)
Don't MissChoice of THREE pre-and post-conference workshops:
Pre-conference Workshop (X): Monday 24th June 2008
Biopharmaceutical Glycosylation and Comparability: Strategy and analytical methods for comparable products and biosimilars
Post-conference Workshop (Y): Thursday 26th June 2008
Regulatory strategies for comparability exercises of biotechnological/ biological medicinal products
Post-conference Workshop (Z): Thursday 26th June 2008
Practical strategy for assessment of immunogenicity
“Good blend of scientific vs. regulatory talks.”
Cytheris
Key PresentationsReducing the impact of process change: Potential issues and strategies
Case studies from industry leaders: site transfer, formulation, scale up, cell line
Focus on: AUC, SLS, SEC, Fluorescent detection systems and more
Aggregation, glycosylation, impurities, stability
Potency, binding, cell-based and immunogenicity assays
Pre-clinical and clinical safety and efficacy
Dealing with the regulators: Guidance, guidelines, overcoming the pitfalls
Quality by Design: Industry and Regulatory Agency perspectives
Opportunity for high level discussion on major areas of difficulty
Who Will You Meet· Dr Thomas J. Porter, Director, Wyeth Biopharma, USA
· Dr Wassim Nashabeh, Director, CMC Regulatory Affairs, Genentech, Inc.,USA
· Dr Brendan Fish, Director of Bioprocess Sciences, MedImmune, UK
· Dr Kathleen Clouse, Director, Division of Monoclonal Antibodies, FDA, USA
· Dr Ned Mozier, Director, Pfizer Global Biologics, Pfizer, USA
· Dr Kowid Ho, Head of Biological Products, Afssaps, France
· Dr Carlo Emanuele Giartosio, Director, MerckSerono, Italy
· Dr Jaya Goyal, Associate Director, Biogen Idec Inc., USA
· Dr Daotial Fu, Director, Bioanalytical Development, Genzyme, USA
· Dr Sue Stephens, Senior Director, Biologics PK, UCB-Group, UK
· Dr Jenny Sims, Head, Novartis Biologics Unit, Switzerland
Make the Most of your time out of the Office
Book on both Comparability and Biosimilars and Save up to £500
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