4th Annual Cell Based Assays 
Event Overview
Biopharmaceutical labs have many obstacles to overcome in developing, validating, maintaining, and transferring complex cell based assays in a quality control environment. Whether you are new to developing and characterizing bioassays or you have several years of experience, you will benefit from discussing your current challenges with industry colleagues. The Cell Based Assays conference has become the meeting place for these scientists to discuss fresh information on how they are approaching solutions to these difficult assays. Regulatory considerations, drug characterization, potency assays, setting acceptance criteria, neutralization antibodies assays, technological advancements, and statistical analysis are only some of the discussion topics. The format for learning is a combination of case studies and interactive panel discussions to address your most pressing assay challenges. |
New for 2008
Assay Development- How to improve the monitoring bioassays
- Measure anti-drug antibodies in the presence of drug
- Use of primary cell line in a lot release bioassay
- Applications for cell line toxicology
- Latest information on validation guidelines
- Validation of host cell impurity
- Differentiate qualification vs. validation requirements
- Use of DOE in validation robustness of potency assays
Potency Assessment
- More information on developing potency assays
- Challenges in selection a potency assay for lot release
- Potency of a Monoclonal Antibody Product against a Cell Surface Receptor
Analysis
- Correct analysis of biological assay data & parallel line analysis
- Setting specification limits on bio-assays
- Match sensitivity of cell based assay to ELISA like methods
controlling sensitivity drift
Specific Strategies to Overcome Cell Based Assay Challenges:
- Transfer criteria for cell based NAB assays to CROs
- New ideas and data to detect antidrug antibodies in the presence of circulating drug
- Improve assay development efficiency and quality
- Establish sufficient assay sensitivity
- Decrease the time required to validate new instruments and assay technologies
- Strategies for quickly developing novel or state-of-the-art cell functional assays
- Interpretation of guidance documents for bioassays
- How to efficiently handle, test and report results for a large volume of sample testing
New Troubleshooting Strategies for Major BioAssay Challenges
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| New Approaches & Methodologies For Development, Validation & Transfer of Cell Based Assays for :
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Sincerely,
Anne Reel
Program Director
Institute for International Research
Email: areel@iirusa.com
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