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 16012


This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Rainer Fedra, VelaLabs, Austria

Markus Fido, VelaLabs, Austria

Siegfried Giess, Paul Ehrlich Institute, Germany

Ulrike Herbrand, Charles River Laboratories, Germany

Dr Manuela Leitner, AGES, Austria

Dr. Norbert Nagel, Sanofi- Deutschland

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
Phaenomena of Stability Testing
  • Introduction to insulin analogues
  • Factors to consider in stability testing
  • Chemical and physical stability
  • Examples of stability phenomena observed for insulin analogues
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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