Dr. Marcus Fido
Mfi Bio-Consulting
Referent:innen
Dr. Ulrike Herbrand
Charles River Laboratories Germany
Dr. Jörg Engelbergs
Paul-Ehrlich-Institut
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.
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.
Please be aware: The recording does not include the Q & A sessions.
Please be aware: The recording does not include the Q & A sessions.
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
Duration of Recording: approx. 5 h 07 min
| ECA-Member*: | € 890,- |
| Regular Fee*: | € 990,- |
| EU/GMP Inspectorates*: | € 495,- |
| APIC Member Discount*: | € 940,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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