Critical reagents, such as serum, dyes, vitamins, binding reagents (proteins), antibodies, and conjugated antibodies, possess unique characteristics that are crucial to assay performance, and therefore need to be examined closely. Even the slightest change in production could significantly impact ligand-binding assay performance, so it’s crucial to develop a critical reagent management strategy to ensure they’re properly characterized and maintain the appropriate level of structural integrity and stability throughout development.
This webinar examines the following topics:
- Pros and cons of in-house and commercial sourcing for critical reagents
- Proper storage conditions to maintain their stability
- FDA guidelines on how to change critical reagents
- Requalifying and optimizing your assay
Nana K.S. Asare, MS
Scientist II, Analytical Services
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