Unique Aspects of OOS Investigations Related to Biotech Products

Learning Level: Intermediate
Time: 1000 - 1130 ET 
Session Length: 1.5 hour

Investigating Out of Specification (OOS) test results is crucial to ensure pharmaceutical product safety and quality. The main objective is to identify the root cause of the OOS result. The QC/Analytical community is generally familiar with the FDA guidance on OOS investigation. However, there are some unique aspects of applying the guidance to biotech products. We will discuss three topics in this session.

  1. OOS related to bioassays
  2. OOS related to cell therapy products
  3. OOS related to muti attribute assays

We have invited three industry experts as panelists to share their success stories and challenges, followed by roundtable discussions.

Learning Objective

  • Understand the unique aspects of OOS investigations related to Biotech products.
  • Share possible scenarios.
  • Share approaches and associated pros and cons.

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Robert De Lange
Senior QC Expert (Bioassay)
Da Ren
Founder and CEO
BioTherapeutics Solutions
Sapan Patel
Associate Director QA

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