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Endotoxin Seminar for Pharmaceutical Industry held in Cologne
For the past few years Lonza has been organizing an Endotoxin Testing Summit at the east coast of the US. The summit focuses on recent developments in the area of endotoxin detection.
The Endotoxin Summit offers a lively forum for scientists and end-users to discuss current challenges and opportunities. During the last summit the idea of organising a similar event in Europe was raised. This would give the opportunity to attendees who have flight or time restrictions for traveling overseas. After some discussions the European Seminar Series was born with workshops being offered in Germany, the UK, and France.
The European Seminar Series started with a 2-days seminar on 24th and 25th September in Cologne, with delegates from the pharmaceutical industry in Germany, Austria, and Switzerland. They participated in an interactive exchange with our experts discussing current topics in the endotoxin community. The focus of these discussions during the first day of the seminar in Cologne was the alternative endotoxin detection assay based on the recombinant factor C. There was an emotional discussion about validation requirements for this assay and issues companies face and the support they would need to use this technology.
There was also insight provided from one of the regulatory instutions in Germany, the Paul Ehrlich Institute, whose representative Ingo Spreitzer talked about why we need an alternative method, perspectives about regulatory changes and why we should start using the assay now. The pharmacopoeial authorities have recognized the need for adapting the pharmacopoeial chapters. In Europe, a dedicated chapter 2.6.32 for methods based on recombinant factor C has already been published as draft and is now being discussed by the workgroup of the EDQM. A few weeks ago the USP also published a draft for the existing chapter <85> that now includes the recombinant factor C assay as compendial method. The audience agreed that this will be highly beneficial in establishing the assay in their labs.
The second day of the seminar had a different focus, where lab automation and low endotoxin recovery was the center of the discussions. Lonza presented the PyroTecTM Pro System as a solution for an automated workflow. This instrument can process up to 42 samples on 2 plates in one run. The benefit with the PyroTecTM Pro Robotic Solution is to automate error prone manual handling steps but keeping the test as flexible with our WinKQCLTM Software as you are used to. In addition, automation will improve data integrity aspects. Our endotoxin expert Thomas Winkler (shown on the left side of the image next to Guiseppe Cagna, Regional Sales Manager DACH) explained how the automation platform in combination with our latest version WinKQCLTM 6 Software can help labs to fulfill all of the requirements for data integrity. The highlight of this day was the demonstration of the PyroTecTM Pro System in our application lab in Cologne. Touching the instrument and seeing it in action is quite impressive and from now on all European customers have the opportunity to get a demo in Cologne to convince themselves of the ease of use and flexibility of our PyroTecTM Pro Solution.
We are looking forward to continue the Endotoxin Testing Seminar Series in October in Manchester/UK!
Written by SST