Understanding the new FDA Guidance for Immunogenicity Testing

Instructor: Ana Menendez
Product ID: 701641
Training Level: Intermediate
  • Duration: 90 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Dec-2011

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Read Frequently Asked Questions

This webinar on the draft FDA Guidance for Immunogenicity Testing will cover recommended approach to design elements of assay development and validation parameters.

Why Should You Attend:

The increase of biopharmaceuticals in the clinic during the past decade has led to an increased awareness on how immunogenicity can make or break a drug. The FDA has issued a Guidance for Industry titled "Assay Development for Immunogenicity Testing of Therapeutic Proteins" Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients.

The US biopharmaceutical industry has followed White Papers and EMEA guidelines in their strategy to detect unwanted antibodies. This presentation reviews and explains the important expectations that the FDA has clarified and required for a successful acceptance of an immunogenicity testing program.

This presentation begins with a general discussion of the role that immunogenicity plays during the development process and important principles to be followed. The next section describes the recommended approach to assay development and discusses the design elements, screening formats and neutralization methods required for the positives in the screening method. Clinical aspects of setting the important cut-point and the minimal dilution are considered. The final two portions discuss how to properly validate the assay and how to implement guidelines in to the sample analysis phase. Special considerations for monoclonal antibodies, RA patients, fusion proteins, endogenous proteins, isotope identification and epitope specificity will also be examined.

Areas Covered in the Seminar:

This presentation reviews the following important topics to understand immunogenicity testing and interpretation when developing biopharmaceuticals:

  • Immunogenicity Testing Strategy.
  • Method Development.
  • Method Validation.
  • Sample Analysis Implementation.
  • Immune Response Confirmation & Characterization.
  • Specific Groups with Risks
Who Will Benefit:

This webinar will provide valuable assistance to all companies that are developing biopharmaceuticals that are NOT being used as vaccines. The employees who will benefit include:

  • Pharmacologists
  • Toxicologists
  • Clinicians
  • Project Managers
  • Regulatory personnel
  • Consultants

Instructor Profile:

Dr. Menendez, is currently an independent consultant and international instructor on GMP/GLP Bioassay Method Development. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular molecular and immunological procedures.Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.

Dr Menendez joined Catalent from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences, she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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