APV symposium on protein reactive leachables
Kursnummer: 7008
- Biotechnology
- Liquid Dosage Forms
- Packaging
- Quality Assurance
- Quality Control / Analytics
- Research and Development
Kursprogramm / Flyer
- 7008_Protein-reactive-leachables.pdf (291 KB)
Termin und Veranstaltungsort
Beginn:
09.10.2024, 14:00 Uhr
Ende:
10.10.2024, 14:00 Uhr
Veranstaltungsort
InterCity Hotel Mainz
Binger Straße 21
55131 Mainz
Deutschland
Tel.: 0049 6131 58851 0
E-Mail: mainz@intercityhotel.com
http://intercityhotel.com
Zielgruppe
This symposium is aimed at pharma professionals and representatives of medical agencies interested in extractables and leachables and wanting to exchange on protein reactive leachables and their possible impact. Apart from an introduction into the topic of protein-reactivity , we want to start a discussion and build a network of professionals working in this field.
Zielsetzung
The guidelines and best practice guides published to date give a solid understanding of how an extraction study is set up, what analytical techniques are expected and how to handle findings from an extraction study with regard to a follow up leachable study. The guidelines view on extractables and leachable is very much through the lens of a toxicologist, evaluating substances migrating from single-use and primary packaging materials for their toxicological potential. However, this concept overlooks what these substances may be doing to the drug substance itself. Any compound interacting with a therapeutic protein by covalent or non-covalent means, may cause the protein to directly lose its therapeutic function or cause it to be immunogenic, leading to the formation of antibodies and worst-case to neutralizing antibodies. The last case is particularly devastating when the therapeutic protein is administered as a replacement therapy, like e.g. erythropoietin (EPO). In this specific case a patient would lose it´s capacity to produce erythrocytes becoming dependent on frequent blood transfusions. As it is difficult to predict what structures may be immunogenic and at which concentration, the evaluation of protein-reactivity should be part of the overall extractable and leachable risk assessment strategy. This symposium will give a brief insight into the regulatory extractable and leachable landscape to build a common ground for participants of all levels. We will discuss the possible risks of protein-reactive extractables and leachables in the context of immunogenicity and the impact on patient safety. Then we will explore different analytical approaches to identify protein-reactive compounds using model substances during extraction studies and how to analyze full-length proteins in product formulation. How in silico and paper-based approaches may be used to assess the risk of protein reactive leachables. Different case studies will be presented to give a real-life insight into possible risks and how they may be mitigated. The presentation session will close with an outlook into the possible future regulatory landscape and how take influence. The symposium will close out with a panel discussion in which all participants are invited to give their view on the current field of protein-reactive extractables and leachables, ask questions and generally build a network of experts.
Veranstalter
Kurfürstenstraße 59
55118 Mainz
Deutschland
Dr. Martin Bornhöft
Tel.: +49 6131 9769-0
E-Mail: info@apv-mainz.de
https://www.apv-mainz.de
Preise
Alle Preise mehrwertsteuerfrei gemäß § 4,22 UStG