Dr Ingo Spreitzer, Section 1/3 Microbiological Safety, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines
Dr Johannes Reich, Endotoxin & Pyrogen Test Service, Microcoat Biotechnologie GmbH
Dr Sven Deutschmann, Chair ECA Pharmaceutical Microbiology Working Group, Adventitious Agents Testing & Alternative Microbiological Methods, Roche Diagnostics GmbH
Thierry Bonnevay, Global Microbiology Analytical Expert, Sanofi Pasteur
Jay Bolden, Senior Biologist at Eli Lilly and Company
In November of 2019 the European Pharmacopoeia (Ph. Eur.) Commission adopted a new General Chapter 2.6.32 entitled: “Test for bacterial endotoxins using recombinant factor C (2.6.32)”. The new Chapter will be published in the coming weeks in Ph. Eur. Supplement 10.3 and available on the EDQM website. The chapter will be effective as of January 1, 2021.
Guidelines for using the test for bacterial endotoxins state in the that the test methods given in monographs and general chapters have been validated in accordance with accepted scientific practice and current recommendations on analytical validation. In consequence, the methods described in general chapters do not have to be re-validated per se, other than in consideration of their use for a specific substance or product in a specific analytical environment.” Thus allowing the recombinant Factor C test to be used as an alternative to the Limulus amoebocyte lysate assay (LAL assay).
This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
- Quality Assurance and Quality Control
- Inspection and Auditing
or who are involved in Endotoxin or Pyrogen testing.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The following points will be presented in 5 short contributions and subsequently discussed in an open panel discussion with the possibility to submit questions:
- Comparison of LAL and rFC test methods
- Benefits of recombinant test methods
- Regulatory Status (US and Europe) of recombinant Factor C Test
- Experiences in pharmaceutical quality control using rFC test
- Different approaches - experiences of a contract laboratory
Pre-Submission of Questions
The participants in this online panel discussion have the opportunity to send questions in advance and during the event, which will be included in the panel discussion. If more questions are submitted than can be discussed in the time frame, the Scientific Board or the discussion leader will select the questions.
You can submit questions to the panel at firstname.lastname@example.org
up to the day before the event. Questions can be also entered directly during the webinar.