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


Non-ECA Members: EUR 2180,--
ECA Members: EUR 1990,--
EU GMP Inspectorates: EUR 1090,--
APIC Members (does not include ECA membership): EUR 2080,--

(All prices excl. VAT)

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 Insa Kather, Sanofi

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 document
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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