Biotech China 2014
7th Annual Comparability for Biologics
Pullman Hotel Cologne
Ex Sofitel, Helenenstrasse 14,
KÖLN,, GERMANY
http://
7th Annual Comparability for Biologics
Informa Life Sciences
Pullman Cologne

Schedule of Presentations:

Tuesday, June 16, 2009
07:55:00 Check-In
08:00:00 Registration and morning coffee
09:00:00 Chairperson’s opening remarks
09:05:00 Selection of acceptance criteria for comparability studies throughout the development lifecycle Wassim Nashabeh
09:45:00 Expectations and experiences of the EMEA regarding change implementation Frits Lekkerkerker
10:25:00 Morning coffee and poster/exhibition viewing time
10:55:00 Regulatory expectations in the US for demonstrating comparability of biotechnology products Earl Dye
11:35:00 Comparability protocols - regulatory experience with the FDA Lotte Niemann
12:15:00 made up of the day's speakers Discussion forum -
12:45:00 Spotlight presentation
13:15:00 Lunch and poster/exhibition viewing time
14:15:00 A Quality by Design approach to comparability of monoclonal antibody glycosylation Daryl Fernandez
14:55:00 Methods to check heterogeneity and PTMs on process change John O’Hara
15:35:00 Afternoon tea and poster/exhibition viewing time
16:05:00 The use of bioassays in assessing comparability Jane Robinson
16:45:00 Developing and validating a whole blood cytokine release assay Aparna Deora
17:25:00 End of Day One followed by drinks in the Exhibition Hall
Wednesday, June 17, 2009
08:30:00 Registration and morning coffee
09:00:00 Chairperson's opening remarks
09:05:00 A case study for demonstration of comparability for post-phase III change of manufacturer for IGF-1 Enona Gopinath
09:45:00 Analytical comparability of a human IgG1 (mAb1) from different manufacturing sites after cell line switch and process changes Manuela Schärpf
10:25:00 Morning coffee and poster/exhibition viewing time
11:05:00 Establishing recombinant thrombin comparability during development Manuela Schärpf
12:25:00 Regulatory considerations when performing comparability studies in relation to process optimisation Kirsten Bislev Hansen
12:25:00 Spotlight presentation
12:55:00 Lunch and poster/exhibition viewing time
13:55:00 The clinical comparability programme Cecil Nick
14:35:00 Rational design and standardised evaluation of novel genetic vaccines David Klatzmann
15:15:00 Afternoon tea and poster/exhibition viewing time
15:45:00 Comparability studies in the development of biosimilar products Hansjörg Toll
16:25:00 Characterisation and comparability of a biosimilar recombinant peptide – a case study of recombinant human insulin Laxmi Adhikary
17:05:00 Final comments from the Chairperson
17:10:00 End of the conference
4th Annual Pharma R&D Asia Congress
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