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Oct 09
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09:00 - 09:10 10 mins
Chairperson's Opening Remarks
09:10 - 09:40 30 mins
Method validation based on total error
  • Harry Yang - Senior Director, Medimmune, USA
09:40 - 10:10 30 mins
Global regulations for bioanalytical method development and validation
  • Anne-Marie Murphy - Global Lead, Pfizer
  • Declan Lowney - Associate Director, Janssen
  • What are the expectations of the FDA vs. EMA vs. Asian regulators for method development, validation and transfer?
  • Experiences with meeting global regional regulatory requirements
  • ICH harmonising requirements
  • Sharing strategies used to meet expectations
10:10 - 10:40 30 mins
Spotlight session
10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
Demystifying the USP Chapters on Bioassay Development and Analysis
  • Steven Walfish - Principal Scientist and Standards Liaison, USP

USP Chapter <1032>, Design and Development of Bioassay provides a framework for bioassay development, though many of the statistical concepts are not implemented from lack of understanding. This talk will cover the use of different statistical designs and analysis for developing a bioassay that is robust.

11:50 - 12:20 30 mins
Spotlight session
12:20 - 12:50 30 mins
The use of sensitivity analysis to set acceptance criteria in the validation of biological assays
  • Graham Healey - Senior Biostatistician, Oncimmune
12:50 - 13:20 30 mins
13:20 - 14:10 50 mins
Live Labs
14:10 - 14:40 30 mins
Implementing bioassays for a kλ-Body
  • Anaëlle Dos Santos - Head of Bioanalytics Unit, Novimmune

A comprehensive suite of highly sensitive and complementary binding and reporter gene assays have been implemented to assess the potency of a kλ-Body as part of product quality analysis and characterization studies.  Results obtained using the different assays were correlated to demonstrate the assays stability indicating properties, locate degradations and initiate the identification of critical quality attributes.

14:40 - 15:10 30 mins
High-throughput Release N-glycan Method for Product Quality Assessment
  • Vithiya Vimalraj - Associate Scientist, GlaxoSmithKline

N-Glycosylation of biotherapeutics is an important critical quality attribute. Glycans can influence protein stability, serum clearance, immunogenicity and pharmacokinetics. Therefore it is crucial to monitor the full glycan profile of a glycoprotein throughout discovery, clinical and manufacturing phases. A High-throughput RapifluorMS N-glycan method has been employed in our lab to address the challenges that are encountered with product quality support and meet aggressive timelines. This presentation will provide an overview of the development workflow to automate all the steps from sample preparation to data analysis of the RapifluorMS released N-glycan analysis.

15:10 - 15:40 30 mins
Spotlight session
15:40 - 16:10 30 mins
Afternoon Coffee
16:10 - 16:40 30 mins
Biotherapeutics Formulation Design in the Age of Lab Automation and Biological Performance Screening
  • Kathrin Schäker-Theobald - Senior Scientist I, NBE HTS Operation & Analytics, AbbVie Deutschland
  • An overlook of the evolution of our automation line addressing scientific as well as data handling matters.
16:40 - 17:10 30 mins
Round-Table Discussion: Automating analytical workflows
  • Mario Richter - Principal Scientist DMPK-BA, AbbVie Deutschland GmbH & Co. KG, Germany
  • Future focuses
  • Data analysis and evaluation strategies
  • Moving away or moving on to alternatives
  • Strategies to implement automation into existing workflows
17:10 - 18:40 90 mins
End of Day Two