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The Potency Assay Guide, Edition II

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The Second Edition of The Potency Assay Guide will be available early 2020. Pre-order your copy today!

Included in the guide:

  • Potency Assay Introduction
    • Why it’s so important, and where to begin
  • Regulatory Requirements
    • A review of how the USP, ICH, and CBER guidelines define potency assay parameters
  • Steps to Validation
    • How to pursue your Target Assay Profile in a phase-appropriate manner
  • Challenges in Potency Assay Development
    • Adapting unique approaches for assay development and statistical design
  • Why use a CRO?
    • How to leverage scientific expertise and compliance-ready facility and procedures
  • Even More Case Study
    • Review of potency assay development for a late stage AAV GT product

Pre-order your copy today:

Please complete the form below to place your order:

Gut Reactions: An ADME-Centric View of the Gut Microbiome, Part I

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Gut Reactions: An ADME-Centric View of the Gut Microbiome; Part II

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A Platform Approach to Functional Potency Assay Development for Gene Therapy Products

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Originally Presented:
Wednesday, November 20, 2019
Analytical Development Summit
Boston, MA

Presenter: Karen Doucette, MBA
Director of Operations, ACF Bioservices

What you will learn:

  • Streamlining development of functional potency assays across diverse product types with custom and complex MOA
  • Bridging the gap between R&D and cGMP for commercially viable potency assays
  • Case studies for in vivo and ex vivo and non-vector based therapies

 

A Platform Approach to Functional Potency Assay Development for Gene Therapy Products

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