Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays
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Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
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Course Description
Part 1: Quantitation Assays
Quantitation assays are critical for the development of biologics and biopharmaceuticals as well as accurate detection of protein biomarkers. Immunoassays for quantitation of protein drugs in biological matrices (ex. plasma, serum, tissue) generally take much longer to develop and are subject to a wider range of interferences than traditional xenobiotic small molecule quantitation assays by LC-MS/MS. Part 1 of this interactive two-day course focuses on these critical assays and will take you step-by-step through the development of quantitation assays for proteins including monoclonal antibodies.
The course begins with basic development, highlighting technical requirements, regulatory requirements and industry trends. We start by detailing how to select and maintain critical reagents, then move to assay formats. This includes understanding physical processes behind the four-parameter model and how to interpret curve shape in terms of assay optimization. Then we move into qualification and validation of the assays to support pre-clinical and clinical studies. Part 1 of this course ends with preparation of the assay for use in a bioanalytical laboratory, including validation, establishing robustness, determining acceptable and practical system suitability criteria and suggestions for long term maintenance of the assay. Finally, this course will go over the different findings observed by the regulatory agencies on those type of assays.
Part 2: Immunogenicity Assays
Part 2 of this course starts with an overview of immunology followed by the requirements of an immunogenicity program, including the establishment of a tiered testing approach for screening, confirmation assay analysis, titer assays and neutralizing antibody assays. The course will explain the selection of the right platform/format depending on the drugs and its usage, including an analysis of strengths and weaknesses of each format. This course then goes on to cover basic development of these assays, highlighting how to develop and label critical antibody reagents. This is followed by a review of current scientific guidelines on how to establish cut-points (with a hands-on calculation workshop with sample data at the end of the course). Optimization of screening assays to improve sensitivity and drug tolerance (amount of drug on board that can interfere with the assay) is also reviewed. Then we move into validation of the assays to support pre-clinical and clinical studies. The course will end with neutralization assays approaches.
Who Should Attend
This 15-hour, two-part course is designed for those who perform, supervise, manage, audit, or oversee the validation of bioanalytical assays in a GLP laboratory. This includes, but is not limited to, professionals in Bioanalytical Development, Quality Assurance, Validation, Regulatory Affairs, Pharmaceutical Development, Clinical Development, Medical Development, and Research and Development groups. Note: This course does not cover analytical assays that are used for characterization of drug substance or for drug product release assays in a GMP laboratory.
This course will also be of interest to Biopharmaceutical Development Companies, Biosimilar Drug Development Professionals, Regulatory Assessors, Consultants, and Clinical Laboratories.
Related Courses
- CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics
- Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
- Process Validation for Drugs and Biologics
- Medical Device Process Validation Training for Professionals
- Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.