 | | Who Should Attend This course is designed for all individuals who develop, validate, perform or monitor bioassays or immunoassays. Individuals who develop assay methodologies, assign computational and analysis criteria, measure and validate performance characteristics, perform, evaluate and troubleshoot problem assays, or are responsible for the quality of the data will benefit from the lessons and examples presented. No prior mathematical or statistical background is required, but attendees should have a basic understanding of bioassays or immunoassays. | | How Attending will Support Your Professional Development - Learn how effective weighting, appropriate nonlinear curve fitting (particularly the 5 parameter logistic), accurate determinations of quantitation limits and other analytical methods will help you develop and manage ill-behaved and well-behaved biological assays
- Understand parallelism, relative potency and dilutional linearity and generate realistic criteria that meet regulatory requirements
- Analyze and effectively troubleshoot problems in biological assays and immunoassays
- Receive a comprehensive workbook with instructor slides and numerous examples drawn from more than 100,000 assays
| | Progressive Training Throughout the Year
Enhance your professional development by attending three training courses in a one year period and save! Register for three courses at once at the full rate, and you will receive a 50% discount off the third course. All registration forms must be received and paid together to qualify for the discount. For group bookings, contact the IBC customer service team at 800-858-4881. | | Course Description Immunoassays and cell-based bioassays are a critical and ubiquitous component of biopharmaceutical testing that require a thorough understanding of the basic computational processes necessary for analysis of the data from these assays. Important considerations will be examined, such as determining optimal assay conditions, establishing valid weighting profiles, choosing appropriate nonlinear or linear regression models, analyzing curve regressions, computing practical limits of sensitivity and acceptable error, measuring nonparallelism and potency accurately, compensating for matrix effects and other fundamental computations. These and other computational decisions will be discussed and examples will be presented showing different considerations. The course will also outline a comprehensive and stepwise method for inspecting immunoassays and bioassays for problems, and for troubleshooting failed assays. This method is based upon a statistical comparison to a set of validated, well characterized historical assays performed and validated by the laboratory. This process allows the analyst to set realistic acceptance criteria that will only flag assays with failed components, identify the failed reagent or incubation condition, assess the impact of that failed component on the results, and indicate a course of action. Attendees will then troubleshoot the failed component from examples selected from thousands of problem assays.
Complete Course Agenda Introduction - Summary of computational requirements necessary for analyzing bioassay and immunoassay data
- Overview of test method validation requirements
- Overview of assay acceptance requirements
Data Reduction - Response variances and weighting: managing ill-behaved and well-behaved assays
- Curve Fitting: when to use 5PL, 4PL, 3PL, linear regression, or other models
- Detection of replicate and dilution outlier and masking criteria
- Concentration confidence limits (error) and determining useful limits of quantitation
- Establishing meaningful cutpoint thresholds
- Optimizing assay design to achieve desired reliability
Parallelism/Dilutional Linearity - Defining parallelism for potency or dilutional linearity studies
- Measuring parallelism and relative potency
- Determining thresholds for parallelism/nonparallelism
- Analyzing nonparallel dose response curves
- Combining relative potency determinations
- Effect of curve model and noise on parallelism and relative potency metrics
- Handling matrix differences and other factors that affect dilutional linearity
Statistical Quality Control and Assay Troubleshooting - Determining the amount of variation introduced by each reagent or incubation condition
- Identifying parameters that measure the performance of each reagent and incubation condition
- Utilizing parameters that diagnose reagent or incubation problems
- Utilizing parameters that measure the impact of problems on results
Test Method Validation and Performance Qualification - Building a reference set of historical assays
- Identifying and managing sources of assay to assay variation
- Analyzing and optimizing test method performance
- Determining the suitability of a test method by analyzing pertinent performance characteristics
- Validating a test method (Performance Qualification)
- Establishing useful, defendable assay acceptance criteria
Assay Troubleshooting - Class exercises will use the information presented to troubleshoot a series of failed assays by:
- Identifying the failed reagent or incubation condition
- Assessing the impact of the failed component on the results
- Deciding course of action (accept, mask outlier and accept, or reject)
Course Instructor John R. Dunn, Ph.D., Chief Technical Officer, Brendan Technologies, Inc.
Dr. Dunn's is a researcher in the fields of tumor cell metabolism, endocrinology, radiology and pharmacology. Dr. Dunn has extensive research and laboratory management experience from several industry positions, including setting up and running a high-volume reference laboratory specializing in immunochemistry. He also was a consultant for assay development and statistics for several laboratories, and served as a technical advisor for several diagnostic reagent manufacturers. Dr. Dunn is founder and head of the development team which manufactures StatLIA, data analysis and management software for the biopharmaceutical and research communities. He conducts training classes and consultations at biopharmaceutical, diagnostic and reagent manufacturers in the U.S. and Europe. |
