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Biological Assay Development, Validation & Maintenance

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Critical Approaches for Critical Assays

April 30 - May 02, 2012 · The Fairmont Copley Plaza Hotel · Boston, MA

Event Overview

Event Overview

Learn How to Get your Assays Approved and Functioning in the Real World

Bioassay scientists are now reaching out and utilizing new technology at a dizzying rate. Quality-by-Design validations are becoming common, statistical tools are implemented during development and cells are being developed for single use applications.

IBC's 22nd International Biological Assay conference is the must attend event for bioassay professionals who want to keep up with these changes. This informative, interactive conference is where scientists gather to discuss the real technical hurdles and how to overcome them.

If you are involved in the nitty-gritty of developing these critical assays, attend this meeting to find out new approaches and hear practical discussions centering around real world problems and solutions. You will learn how to get your assays approved and functioning with today's technologies. This conference focuses on the tools you need to quickly and efficiently develop critical biological assays needed for successful product development.

The Life-Cycle Approach to Bioassay Methods ¡V Cradle to Commercialization

Developing Bioassays

  • A dedicated workshop will specifically address bioassay development basics including the often overlooked problems you may face.

Validating Bioassays

  • Hear how to validate methods using QbD as proposed by the new USP chapters and ICH approaches modified for biological methods.
  • Case studies in this session include multiplexed assays, animal assays, cell-based assays for monoclonal antibodies, serological neutralizing assays, viral based methods and ELISAs.

Maintaining Bioassays

  • Learn how to qualify rare reagents, re-qualify new reference material, utilize monitoring tools to identify emerging assay trends and establish systematic approaches to assure your method remains

Plus, Two New Practical Pre-Conference Workshops

  • Advanced Tools for Assessing and Controlling Assay Variability and Spurious OOS Results
  • Bioassay Development Basics 101

Who Should Attend?

This highly practical and technical conference is specially designed for scientists, analysts, assay statisticians, and managers who work with biological assays during biotech and biopharmaceutical development or routine product release. Regulatory and Quality Assurance professionals who deal with submitting or overseeing complex assays will also gain much needed insight to successfully deal with biological assays.