Reducing Variability in Cell-Based Methods Using Process Controls
Instructor:
Gwen Wise Blackman
Product ID: 705933
Training Level: Intermediate
- Duration: 60 Min
Why Should You Attend:
Cell-based methods are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays that use cells have unique requirements due to the variable nature of critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts. Monitoring numerous parameters helps assist laboratory scientists, laboratory managers, QC, and QA personnel identify and manage trends that could lead to OOS/OOT results. Since the number of parameters evaluated is dependent on the cell-type, assay-type, and number of critical component or reagents.
Areas Covered in the Webinar:
- Understanding the nature of cell-based methods
- Determining critical components to monitor
- Use of DOE to define assay limits
- Setting appropriate limits for reagents
- Reagent supply and sample handling
- Pre-test of critical reagents
- Testing robustness /ruggedness/ selectivity/specificity prior to validation
- Managing analyst variability
- Designing control charts
- Setting alert and action limits
- Writing a detailed method
Who Will Benefit:
- Quality Assurance
- Quality Control
- Lab Managers
- Development Scientists
- Validation Scientists
- Laboratory Analysts
Gwen Wise Blackman
Manager, Salix Pharmaceuticals
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Immunogenicity, Technology Transfer from client sites, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.
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