Transitioning Complex Cell-Based Bioassays from the Non-Regulated Lab to the GMP Test Facility: Executing a Successful Transfer

Transitioning complex cell-based bioassays betweeen laboratories often contributes to high variability and marked faliure of assays. Careful attention to specific details can enhance ruggedness in cell-based bioassays leading to greater percentage of assays meeting acceptance criteria and less down-time. Parameters that must be addressed include documentation of the assay, transfer of knowledge surrounding the performance of the assay, the effect of defined small changes to the assay procedure, and specifics of new analyst training.

Areas Covered in the seminar:

• Importance of documenting the entire method, defining how to train the analyst, determing when the assay is considered successfully transferred and when an analyst is trained to performt he assay.
• Monitoring the assay for ruggedness during early optimization through method transfer.
• Setting criteria for assay acceptance and new analyst training.
• Defining "proficient to perform" the assay and "proficient to train".

Who will benefit:

This webinar will provide guidance in developing assays that will meet specifications thus reducing OOS and OOT results:

• Science staff designing, validating and transferring new assays
• Managers certifying new analysts
• Laboratory managers designing assay transfer and validation

Instructor Profile:

Dr. Wise-Blackman, is currently Senior Manager, Method Development and Validation, at the Catalent Pharma Solutions RTP-Bio site. Dr. Wise-Blackman leads a team that successfully develops, optimizes, validates, and performs cell-based assays for lot release and stability projects in a GxP environment She was the co-recipient of both the Customer Focus Award for 1st Quarter FY08 and 3rd Quarter FY2004 and the Presidents Award for FY2004. Her expertise is GMP bioassays to support release and stability testing of biotechnology products, GLP ELISA assay development and validation, Cell Based Screens, and Receptor Binding Assays. Dr. Wise-Blackman was previously employed at Dupont Pharmaceuticals for nine years, working in the cardiovascular pharmacology and high throughput screening departments. She received her Ph.D. in Pharmacology from the University of Virginia, Charlottesville, VA and her Bachelor of Science in Biology from the Massachusetts Institute of Technology, Cambridge, MA.

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