Bioassays and Bioanalytics & Stability Testing of Biological and Biotechnological Drug Substances and Drug Products

Bioassays and Bioanalytics & Stability Testing of Biological and Biotechnological Drug Substances and Drug Products

Copenhagen, Denmark

Course No 16682


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Rainer Fedra, VelaLabs, Austria

Markus Fido, VelaLabs, Austria

Siegfried Giess, form. Paul Ehrlich Institue, Germany

Ulrike Herbrand, Charles River Laboratories, Germany

Michael Leiss, Roche Diagnostics, Germany

Dr Manuela Leitner, AGES, Austria

Target Group

  • Manufacturing process professionals
  • QA/QC staff and regulatory personnel
  • Clinical staff, pharmacologists and toxicologists
  • Project Managers & outsourcing personnel
  • Analytical chemists and biochemists


Bioassays and Bioanalytics

Introduction to Bioassays and Bioanalytical Methods

  • What is a potency assay?
  • Product analytics versus Bioanalytics (preclinical & clinical approach)
  • Why do we need bioassays?
  • Characterisation of Biopharmaceuticals & Biosimilars
Regulatory Expectations and Requirements on Bioassays and Bioanalytical Methods
  • Introduction and general aspects
  • Bioassays and methods – expected data
  • Guidance documents
  • Development I - Selecting Methods and Types of Assays
    • Assay types
    • Feasibility
    • Preparing the cell bank
    • Optimization parameters
    • Replacement methods for primary assays
    • Readouts
    Development II – focus on clinical assays (PK/PD/ADA)
    • Standards and controls
    • Eliminating edge and hook effects
    • Setting system suitability criteria
    GMP Pre-Validation of Bioactivity (Potency) Assays
    • Choice of statistical models
    • Defining and improving intermediate precision
    • Process controls
    GMP Validation Protocol of Bioactivity (Potency) Assays
    • Guidelines and requirements
    • Validation parameters
    • Setting realistic sample specs for validation
    • Phase specific validation
    • Validation report
    Development of Immunoassays for GCLP Bioanalytics
    • PK and immunogenicity
    • DOE versus OFAT
    GCLP Validation of Immunoassays with Focus on Bioanalytics
    • Critical parameters: accuracy, sensitivity & precision
    • Population cut-point and confirmatory assays
    • Stability of positive controls in biological matrix
    • Incurred sample re-analysis
    Workshops Session
    1. Validation Protocol Workshop for Bioactivity (Potency) Bioassays
    2. Validation Protocol Workshop for PK/PD and Immunogenicity Assays

    Strategies and Techniques to improve Assays
    • Improve accuracy and repeatability
    • Avoid common technical errors
    Method Transfer
    • How to transfer a method?
    • Transfer tools during product development
    • Donor and Acceptor
    • Investigation, calculation and comparison of method parameters

    Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

    Stability Testing of Biological and Biotechnological Drug Substances and Drug Products
    • Biologicals and relevant guidelines
    • Specific differences between chemical entities and biologicals
    • Stability-indicating profile of Monoclonal Antibodies and Immunoglobulins
    • Storage conditions
    • Impact of changes on stability
    • Submitting stability data within the CTD structure
    Stability Studies and Shelf-Life Determination, starting Activities and Study Report
    • Prerequisites for performing a stab study
    • Concepts for study design and reporting
    • Start, study performance and study closing
    • Regulatory aspects during product development
    • Objectives for a final stab study report
    Stability Studies beyond Lot Stability
    • Selection of appropriate, sensitive methods
    • Analysis of stressed samples
    • Statistical interpretation of shifts and drifts
    • Acceptance limits
    Degradation of Polysorbate
    • Mechanisms of Polysorbate degradation
    • Consequences of Polysorbate degradation
    • Analytical tool box for degradation assessment
    Stability requirements of the new Guideline on Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
    • Control of excipients
    • Specifications, batch analysis
    • Stability data
    • Shelf-life determination
    • Post approval extension
    • Substantial amendments
    Workshop I:
    Study Design, Impurities and Stability Specifications

    Workshop II:
    Potency Assays

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