On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Presenter: Todd Lester, Associate Director at BioAgilytix

Co-Hosted with: Bioanalysis Zone

The demonstration of similar immunogenicity is a critical requirement for the demonstration of biosimilarity between a biosimilar candidate and the respective reference product. In their webinar, Mr. Lester discusses what the new AAPS White Paper recommends for immunogenicity assays supporting biosimilars., addressing questions such as:

  • What are the requirements for immunogenicity assessments of biosimilars?
  • Why do the FDA and EMA recommend the use of a single, biosimilar-based assay?
  • How are anti-drug antibody (ADA) assays developed and validated for the support of biosimilar drug development programs?
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    Cell-Based Assays

    Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

    Pharmacokinetics & Pharmacodynamics (PK/PD)

    See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

    Case Studies

    Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

    Tell Us About Your Project

    What are your specific assay needs? Let’s schedule a conversation to review your
    questions and requirements with one of our scientists.

    SPEAK TO A SCIENTIST

Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

Pharmacokinetics & Pharmacodynamics (PK/PD)

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Case Studies

Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.

SPEAK TO A SCIENTIST
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