Training Session T1 - Tuesday April 2, 2019, 7am to 5:30pm

"Current & Effective Strategies for Critical Reagent Characterization, Storage, LT Stability, Re-testing and Life Cycle Management for LBA & Flow Cytometry PK, ADA and Biomarkers Assays & Bioanalytical Troubleshooting of Critical Reagents Issues"

Recent Advancements and New Frontiers for the Bioanalytical Lab

Part 1: Critical Reagents Management: Challenges & Approaches
  • Lesson 1:

    Evolution of WRIB Recommendations on Critical Reagents from 2015 to 2018: Where are we now and what next?

  • Lesson 2:

    Type of Critical Reagents used in Flow Cytometry Instrumentation and Application in Drug Discovery Development: Similarities and differences between LBA and Flow Cytometry Critical Reagents

  • Lesson 3:

    Defining Processes for Developing Continuous Improvement in Workflows, Overcoming Dogma and Bringing Value in Critical Reagents Management

  • Panel Discussion:

    Critical Reagents Management: Challenges & Approaches Panel Discussion

Part 2: Characterization & Storage
  • Lesson 4:

    LBA Critical Reagent Characterization & Storage: Key tests to ensure characterization vs. traditional qualification by assay performance. Pros & Cons

  • Lesson 5:

    Impact of LBA Critical Reagents Characterization, Handling and Storage on ADA Assays

  • Lesson 6:

    Critical Reagents Characterization and Storage for Flow Cytometry: Preparation & Staining of Cells, Current Protocol for Fluorescence Labeling of Purified Antibodies

  • Panel Discussion:

    Characterization & Storage Panel Discussion

Part 3: LT Stability & Re-testing
  • Lesson 7:

    Critical Reagents Long Term Stability & Re-testing: How extensive should we characterize the stability of critical reagents, especially labeled reagents, used for LBA Assays?

  • Lesson 8:

    Lot-to-lot Reproducibility/Stability and Life Cycle Management of Antibody Reagents for Flow Cytometry

  • Panel Discussion:

    LT Stability & Re-testing Panel Discussion

Part 4: Life Cycle Management
  • Lesson 9:

    Importance of LBA Critical Reagents Life Cycle Management for Successful Biotherapeutics Discovery & Development: PK & Biomarkers Assays

  • Lesson 10:

    Rigorous & Robust LBA Critical Reagent Life Cycle Management for Consistent and Reliable Performance of ADA Assays

  • Panel Discussion:

    Life Cycle Management Panel Discussion

Part 5: Bioanalytical Troubleshooting
  • Lesson 11:

    Critical Reagent Issues & Solutions for PK Assays: Bioanalytical Troubleshooting

  • Lesson 12:

    Critical Reagent Issues & Solutions for ADA Assays: Bioanalytical Troubleshooting

  • Lesson 13:

    Critical Reagent Issues & Solutions for Biomarkers Assays & Bioanalytical Troubleshooting: Biomarkers Calibrator Material Selection and Resulting Calculations

  • Lesson 14:

    Reagent Issues for Flow Cytometry Assays: Bioanalytical Troubleshooting

  • Panel Discussion:

    Bioanalytical Troubleshooting Panel Discussion



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