BioAnalytical Method Development 
Cell Based Assays- Co-Located
Cell Based Assays
in Drug Development for Biopharmaceuticals
InterContinental Hotel San Francisco, CA www.iirusa.com/cba
New Approaches & Methodologies for Development,Validation & Transfer of Cell Based Assays for:
in Drug Development for Biopharmaceuticals
InterContinental Hotel San Francisco, CA www.iirusa.com/cba
New Approaches & Methodologies for Development,Validation & Transfer of Cell Based Assays for:
- Potency
- Immunogenicity
- Characterization
- Immunotoxicology
- In Vitro Toxicology
- New Case Studies & Discussions of Novel Approaches & Methodologies for Development,Validation & Transfer of Cell Based Assays
- How to improve the monitoring of bioassays
- Measure anti-drug antibodies in the presence of drug
- Differentiate qualification vs. validation requirements
- Use of DOE in validation robustness of potency assays
- Challenges in the selection of a potency assay for lot release
- Potency of a Monoclonal Antibody Product against a Cell Surface Receptor
- Correct analysis of biological assay data & parallel line analysis
- Match sensitivity of cell based assay to ELISA like methods controlling sensitivity drift
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