Mariska ter Haak

Mariska ter Haak

Company: IN8bio

Job title: Director, Analytical Development


Panel Discussion: The Strategic Path from Assay Development to Validation to Fast Track Regulatory Approval 2:30 pm

How do we establish regulatory compliant assays that satisfy quality and validation requirements? What is the best time to begin the process of method validation? At what point is full validation required? How to strategize the different quality standards depending on the assay phase?Read more

day: Day 1 Track 2 AM

Developing Successful Potency Assays to Determine Activity of Your Cell Therapy Product 1:00 pm - 3:00 pm

There is no single test that can adequately measure the product attributes that predict clinical efficacy; therefore, developing a successful potency assay is notoriously hard to accomplish. Additionally, to successfully develop a potency assay, many challenges must be overcome, including the inherent variability of starting materials, limited lot size and material for testing, limited stability,…Read more

day: Pre-Conference Workshop Day - Workshop D

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