Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Copenhagen, Denmark

Course No 16209


Costs

Non-ECA Members: EUR 890,--
ECA Members: EUR 790,--
EU GMP Inspectorates: EUR 445,--
APIC Members (does not include ECA membership): EUR 850,--

(All prices excl. VAT)

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

Speakers

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

Objectives

During this course you will get to know the relevant aspects of stability testing for biological and biotechnological drug substances and drug products. You will learn about

  • the basic requirements of stability testing and stability study design from the supervisory authority’s view
  • the peculiarities of stability indicating analytical methods
  • optimising strategies regarding packaging and storage of biological/biotechnological material
  • how to submit stability data for a marketing authorisation dossier according to the new Guideline on Quality Documentation.

Background

The active components in biotechnological/biological products are typically proteins and/or polypeptides. They have distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm their stability during the intended storage period. The products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear. In order to ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary.

The evaluation of stability may necessitate complex analytical methodologies. Appropriate physicochemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program.

In order to get the approval to conduct a clinical trial data have to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Product (IMP). In the new Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials particular provisions are laid down on how to document stability and other quality related data within the CTD structure.

Target Group

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

Programme

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
Phenomena 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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