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

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

Kosten

ECA-Member*: EUR 890,--
Regular Fee*: EUR 990,--
EU/GMP Inspectorates*: EUR 495,--
APIC Member Discount*: EUR 940,--

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 Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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

 

Recording from 28 October 2021

Duration of Recording: approx. 5 h 07 min

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