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Biological Assays: Accelerating Your Development and Validation Practices


The Industry's Most Interactive Event to Accelerate Your Bioassay Projects

May 05-07, 2014 · DoubleTree by Hilton Berkeley Marina · Berkeley, CA

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Alternative Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese
  • English

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Event Overview

Event Overview

Hélène Gazzano-Santoro

Keynote Address: Interested in the future of bioassays? Hear about new technical and regulatory trends from one of the industry's most seasoned and knowledgeable practitioners.
Featuring: Dr. Hélène Gazzano-Santoro of Genentech

New Techniques to Benchmark your Bioassay Projects

  • Outlier analyses for bioassays: statistical basics, novel as well as "tried-and-true" approaches to keep your assays running and your results reliable.
  • Reference programs for bioassays: practical insights into using primary reference standards and assigning the potency to secondary (in house) reference standards. Hear statistical approaches you can implement in your facility.
  • Case studies from MedImmune, Pfizer, Peregrine and Emergent BioSolutions on developing bioassay methods, including ADCC methods with only a single cell line, growth inhibition assays, and what it takes to switch from one method to another.
  • Stability Indicating Properties of Bioassays: Learn how to design the stability studies, analyze the data and hear case studies from Biogen-Idec and Amgen on what happens when aggregates form in your product.

» Register Today!

Practical, Hands-On Advice On How to Develop and Maintain Your Potency Assay Program

Each year we discuss the nitty-gritty details of what goes wrong and how you can avoid these looming pitfalls. Bioassay scientists from around the world gather at this conference because they know that the most current topics, trends and problems will be discussed in an open and dynamic environment.

IBC's 24th annual bioassay event is the longest-running conference which tackles the critical potency bioassay. Only at this conference will you find just the right mix of educational, technical, statistical and regulatory input you need to do your job better. The topics presented in this meeting are determined through the input of bioassay scientists like you who are also trying to overcome the challenges of developing, validating, transferring and maintaining bioassays.

2014 Highlights:

  • Statistical and Practical Approaches to handling outliers and noisy data. Including:
    • Statistical primer to help you understand proposed approaches
    • Newest statistical tools for taming your noisy data
    • Regulatory approaches which will keep your QA and the regulators happy
    • Real case studies, with real data and real decision making to show you how it works
  • Hands-on Case Studies to help you benchmark your projects. Case studies include:
    • Practical and regulatory considerations for changing from one potency assay to another
    • What it takes to develop your own thaw-and-use analytical cell bank
    • Developing and choosing assays for bifunctional molecules
  • Stability Indicating Properties of Potency Assays
    • Statistical considerations of study design and data analysis
    • Case studies delineating the effect of protein aggregates on various types of bioassays
  • Taking Care of the Critical Business of Developing a Robust Potency Reference Program
    • The Role of the International Reference in a Bioassay Development and how it can help your development projects.
    • The truth about how to qualify the in-house working reference.
    • Practical truths about selecting and maintaining a reference material which will keep you out of regulatory hot water.

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