Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays

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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.

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 then goes on to cover basic development of these assays, highlighting how to develop and label critical antibody reagents, different assay formats (ex. bridge, sandwich), including an analysis of strengths and weaknesses of each format. 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 minimize outliers is also reviewed. The sensitivity of various assays to drug (assay drug tolerance) will be discussed and an overview of available technologies and sample pre-treatment approaches will be reviewed. Then we move into validation of the assays to support pre-clinical and clinical studies. The course will end with concepts of risk based testing approaches.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend

This two-day, 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 Analytical Development, Quality Control, Quality Assurance, Validation, Regulatory Affairs, Pharmaceutical Development, Clinical Development, Medical Development, and Research and Development groups.

This course will also be of interest to Biopharmaceutical Development Companies, Biosimilar Drug Development Professionals, Regulatory Assessors, Consultants, and Clinical Laboratories.

Learning Objectives

Upon completion of this course, attendees will have a clear understanding of regulatory agency expectations for bioanalytical development, and will have gained the background knowledge necessary to effectively plan bioanalytical assay development and validation programs for both quantitation assays and PK studies. Additionally, participants will learn to develop immunogenicity assays for detecting anti-drug antibodies for both marketed products and products in clinical development. Attendees will develop expertise in writing protocols, reports performing calculations, and acceptance limits for bioassay method validation.

Participants will have acquired insight into how to avoid common development and validation pitfalls and be able to quickly discriminate compliant from non-compliant validation activities. In addition, attendees will gain practical experience in applying what they have learned during hands on problem solving and calculations workshops.

Past Participant Comments

"This course was very comprehensive, practical and clear; given by a Course Director 'who has been there.'" Denis Groleau, Group Leader & Sr. Research Officer, BRI-NRC