- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Forced Degradation for Biologics
18 - 19 January 2012
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The 3rd Annual Forced Degradation for Biologics 2012: Discover the latest strategies for designing the best forced degradation study; how best to ensure stability-indicating methods; forced degradation for characterisation; and forced degradation for evaluating formulation
Conference overview
Informa Life Sciences’ conference on Forced Degradation for Biologics will deliver the most up-to-date case studies on the forced degradation studies being implemented in the leading biotech companies. This conference is a must for research scientists, analytical experts, stability managers and contract manufacturing organisations in order to better understand the common problems occuring in these studies and hear how best to solve them in order to run a more efficient and cost effective study.
Conference highlights - Case studies, regulatory submission requirements and hot topics on best study design, protein characterisation and methods of improving stability and formulation
- Regulatory insight from the MHRA and MedImmune on current guidance insight and how best for industry to implement these requirements
- Hear from Amgen, GSK, Pfizer and UCB on how to design the best forced degradation study for a variety of complex proteins: PEGylated proteins, Fusion proteins and Biosimilars
- NEW discussion panel delving into the strategies for improving forced degradation studies for complex proteins: Input from Roche and OncoMed Pharmaceuticals
- Get the latest data from Genentech and Roche on the optimal methods for characterising proteins
- Learn what the latest analytical techniques are for monitoring stability and characterising your protein: Presentations from Dr Jane Robinson and Professor Tudor Arvinte
- New discussion panel covering how forced degradation can be implemented in regards to Quality by Design: Input from Sanofi Pasteur and Dr Jane Robinson
- NEW SESSION: Gain insight into how forced degradation data is used to improve protein stability and formulation - GSK, Sanofi Pasteur and Pfizer provide their latest data
Choose from 2 interactive workshops and a NEW evening seminar
Pre-conference workshop: Tuesday 17 January 2012
Protein aggregation: The good, the bad and the ugly
This interactive workshops gives the much needed overview of the newly emerging tools and techniques to monitor and predict aggregation. With forced degradation studies being an integral part of ensuring the stability and quality of your prooduct, this workshops aims to understand better the causes and mechanism of aggregation, the effects of sub-visible particulats to help ensure you have the best product possible.
Led by Dr Jennifer McManus, National University of Ireland Maynooth, NIBRT, Ireland
BRAND NEW Evening seminar: Wednesday 18 January 2012
Regulatory considerations and implementation for forced degradation studies
With guidelines for forced degradation studies for biologics being unclear and not well defined, this 2 hour seminar will delve further into the key regulatory requirements regarding limits of glycosylation/oxidation/deamidation of your product, and how to overcome the key regulatory hurdles in industry
BRAND NEW Post-conference workshop: Friday 20 January 2012
Forced degradation and formulation screening
With industry starting to produce more and more complex proteins, such as vaccines, antibody fragments and other recombinant proteins, the need to correctly understand how your formulation changes during forced degradation studies is essential in order to ensure product stability later of down the development pipeline. This workshop covers how best to optimise your formulation, to what extent does the formulation need to be changed, what stresses cause what changes in formulation and how this has been experienced by industry.
Led by Profesor Tudor Arvinte, University of Genenva, Therapeomics, Switzerland
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With an MHRA representative and 14 industry case studies, this 2012 event provides essential regulatory and practical insight to optimise your stress studies
With an MHRA representative and 14 industry case studies, this 2012 event provides essential regulatory and practical insight to optimise your stress studies
Dr Advait Badkar
Group Leader- Senior Principal Scientist
Pfizer
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Dr Didier Clenet
Research Scientist, BioProcess R&D
Sanofi Pasteur
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Dr Ken Waterman
Research Fellow
Pfizer
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Professor Tudor Arvinte
Chairman and CEO
Therapeomic Inc
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- Dr Paul Marshall, Senior Pharmaceutical Assessor, MHRA, UK
- Dr J Andrea Ji, Scientist, Late Stage Pharmaceutical & Processing Development, Genentech Inc, USA(tbc)
- Dr Smita Thobhani, Senior Development Scientist, UCB, UK
- Dr Steffen Kiessig, Group Head, F. Hoffmann-La Roche, Switzerland
- Dr Cecilia Reid, Investigator - Biopharm Analytical & Formulation Research, GlaxoSmithKline, UK
- Dr Andrea Hawe, Postdoctural Scientist, Biologicas Formulation Group, Leiden/Amsterdam Centre for Drug Research, Leiden University, The Netherlands
- Dr Tanvir Tabish, Principal Scientist, GlaxoSmithKline, UK
- Dr Henrik Naested, Senior Scientist, Symphogen A/S, Denmark
EXCLUSIVE FOR 2012
Forced Degradation for Biologics will be co-located with Forced Degradation for Pharmaceuticals. For more details visit www.informa-ls.com/forceddeg
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Dates and Venues
18 Jan 2012 - 19 Jan 2012
etc venues - Dexter House, London, UK
Join our brand new Forced Degradation for Biologics LinkedIn group to connect with your peers. Get involved in all the current discussions and pose your questions to the experts
Great new conference extras!!!
PRE-CONFERENCE WORKSHOP W: Tuesday 17 January 2012
Protein Aggregation: How to Measure it- the Good, the Bad and the Ugly
Led by Jennifer McManus, Head of Aggregation Group, National University of Ireland, Ireland
EVENING SEMINAR X: Wednesday 18 January 2012
Regulatory Considerations and Implementation for Forced Degradation Studies
POST CONFERENCE WORKSHOP Y: Friday 20 January 2012
Forced Degradation and Formulation Screening
Led by Professor Tudor Arvinte, Chairman, CEO, Therapeomic Inc., School of Pharmacy, University of Geneva, Switzerland
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