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

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    "This course was very detailed and the instructor was very knowledgeable about many scientific assays. It was much more relatable than other courses I have taken because of the instructor’s ability to explain the concepts at a researcher’s level.'"  


    Samantha M., Research Tech., LifeNet Health

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    "The course was well organized and the course director is very knowledgeable. The case studies provided very good practical examples pertaining to current drugs in development.'"


    Trong D., Associate Scientist, Pearl Therapeutics

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    Slide title

    "The course was more informative and closer to real life situations than others I’ve taken. In addition, it was very interactive.'" 


    Josette A., Associate Scientist, AGTC

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    "This course was very comprehensive, practical and clear, given by a Course Director who has been there.'"


    Denis G., Group Leader & Sr. Research Officer, BRI-NRC

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    "It's a great course. Useful for studying the basic issues of PK and immunogenicity assay."


    Ekaterina K., Senior Researcher of Laboratory/ Immunological Methods, BIOCAD

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Optimize Immunogenicity Assay Validation With Risk Assessment Training From CfPIE

Validating assays for complex biologics poses many challenges. Matrix interference, drug tolerance, and more can put your entire study at risk. 



The Center for Professional Innovation and Education (CfPIE) offers a focused, practical approach to PK development and ligand binding assay validation, teaching participants how to meet global regulatory standards and avoid the pitfalls that can delay or derail approval.

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 PK assay development 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 types 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 their 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 on to validation of the assays to support pre-clinical and clinical studies. The course will end with neutralization assay 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.

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  • 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 and reports, performing calculations, and setting 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 noncompliant validation activities. In addition, attendees will gain practical experience in applying what they have learned during hands-on problem-solving and calculation workshops.

  • Agenda


    Section 1: Immunochemistry Basics

    • Types of assays overview
    • Antibody chemistry, class and subtype 
    • Preparation and purification of monoclonal and polyclonal antibodies

    Section 2: Assay Formats

    • Basic sandwich ELISA format
    • Alternative formats (ex. direct, competition)
    • Detection techniques (ex. absorbance, luminescence)
    • Multiplexing
    • Instrument platforms
    • Critical reagent qualification/Lot Bridging

    Section 3: Modeling and Analyzing Data

    • Critical criteria for a PK assay
    • Linear, four and five-parameter curves
    • Anchor Points
    • Troubleshooting assay performance using curve model results
    • Determining precision, accuracy and total error following white paper guidance 
    • Assay acceptance criteria
    • The importance of selectivity in assay development

    Section 4: Assay Validation

    • Test method SOPs
    • FDA and draft EMA guidance for assay validation
    • Current required parameters for assay validation
    • The validation report
    • Incurred sample reanalysis

    Section 5: Sample Management

    • Sample collection
    • Material storage: reagent, reference material, test samples

    Section 6: Immunogenicity and Immunology

    • Basic immunology
    • Immunogenicity for biologics, biosimilar, gene therapy and cell therapy.
    • The different immune response

    Section 7: Immunogenicity Assays

    • ADA
    • NAb
    • Hypersensitivity and IgE testing

    Section 8: Immunogenicity Testing Considerations

    • Pre-clinical versus clinical testing
    • Different assay platforms: what to choose?
    • Case study of IgE response 
    • Case study of a wrong platform selected

    Section 9: Assay Development

    • Practical considerations
    • Positive controls
    • Definitions
    • Interference – Signal enhancement
    • Interference – Signal inhibition
    • Topics for discussion
    • Considerations for mAbs

    Section 10: Regulatory Guidelines for Validation

    • EMA guidance
    • FDA guidance
    • EMA draft guidance for monoclonal antibodies
    • Health agencies immunogenicity findings

    Section 11: Risk-Based Approach to Testing

    • Likelihood and consequences considerations
    • Historical anti-drug antibody responses
    • Scientific white papers

    Section 12: Immunogenicity Assay Validation

    • Validation parameters: comparing FDA and EMA guidance  
    • Cut Point
    • Sensitivity
    • System suitability controls
    • Case studies

    Section 13: Biosimilar

    • Background
    • PK
    • ADA
    • NAb

    Highly Qualified Instructor


    This course is led by Xiao-Yan Cai, Ph.D., an accomplished industry scientist with deeply rooted experience in bioanalytical method qualification and assay validation. As a peer to the life science professionals she teaches, Dr. Cai brings practical solutions to real-world challenges, with every session grounded in industry best practices.

  • Testimonials

    "Great information and helpful personal anecdotes/reference material. It was great to hear from the director's real-world experience with these assays"

    Evan G., Senior Manager, Clinical Bioanalysis Unit, SAB Biotherapeutics


    "This course was very detailed and the instructor was very knowledgeable about many scientific assays. It was much more relatable than other courses I have taken because of the instructor’s ability to explain the concepts at a researcher’s level.'"

    Samantha M., Research Tech., LifeNet Health


    "The course was well organized and the course director is very knowledgeable. The case studies provided very good practical examples pertaining to current drugs in development.'"

    Trong D., Associate Scientist, Pearl Therapeutics


    "The course was more informative and closer to real life situations than others I’ve taken. In addition, it was very interactive.'"

    Josette A., Associate Scientist, AGTC


    "This course was very comprehensive, practical and clear, given by a Course Director who has been there.'"

    Denis G., Group Leader & Sr. Research Officer, BRI-NRC


    "It's a great course. Useful for studying the basic issues of PK and immunogenicity assay."

    Ekaterina K., Senior Researcher of Laboratory/ Immunological Methods, BIOCAD

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.

Register Today to Advance Your Skills in Bioanalytical Assay Development and Qualification

Master compliant assay development. Register now for CfPIE's Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays course. You can contact us online or call 610-708-2264 to connect with a personal Training Advisor.