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

22-24 June 2016, Copenhagen, Denmark

Course No. 15525



Rainer Fedra, VelaLabs, Austria
Markus Fido, VelaLabs, Austria
Tino Galgon, IDT Biologika, Germany
Siegfried Giess, Paul Ehrlich Institute, Germany
Ulrike Herbrand, Charles River Laboratories, Germany

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
GMP and G(C)(L)P Guidelines (EMA & FDA Overview and Interpretation
  • Key regulatory guidelines and industry white papers
  • Life cycle of biopharmaceuticals
  • Risk assessment
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
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 of Biological and 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
Optimising Packaging and Storage Conditions for Biotech Products
  • Peculiarities of biotech products
  • Transport/storage conditions:
  • Planning of stability testing considering the supply chain
  • Cost-benefit considerations
  • Examples of stability studies
  • Presentation and documentation of data
  • Packaging
  • Specific characteristics of packaging materials
  • Photostability studies
  • Transportation stress studies
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


This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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