Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online Training

Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online Training

Seminar Nr. 20284

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

All times mentioned are CEST.

Kosten

ECA-Member*: EUR 990,--
Regular Fee*: EUR 1090,--
EU/GMP Inspectorates*: EUR 545,--
APIC Member Discount*: EUR 1040,--

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Jörg Engelbergs, Paul Ehrlich Institute, Germany
Rainer Fedra, VelaLabs, Austria
Dr Markus Fido, MFi Bio-Consulting, Austria
Dr Ulrike Herbrand, Charles River Laboratories, Germany
Dr Michael Leiss, Roche, Germany

Zielsetzung

During this Live Online Training 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

Hintergrund

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.

Zielgruppe

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

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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
Study Design, Impurities and Stability Specifications

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

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