In this webinar, FUJIFILM Wako Chemicals Europe GmbH will present the results of a study evaluating how NC stability in endotoxin detection reagents affects assay performance.
Endotoxin testing is an important safety test for pharmaceuticals and medical devices. Although horseshoe crab-derived Limulus amebocyte lysate (LAL) reagents have traditionally been used, recombinant endotoxin detection reagents are attracting increasing attention as more sustainable alternatives. However, maintaining negative control (NC) stability can be more challenging with recombinant reagents, potentially affecting assay performance and the reliability and sensitivity of endotoxin measurements.
NC instability may also present challenges when performing testing in accordance with pharmacopoeial requirements, which require the NC to show no reaction or remain below the blank-test limit. In addition, users may face difficulties in determining how to evaluate equivalence between conventional LAL reagents and recombinant reagents, as well as how to conduct the validation.
The webinar will discuss how PYROSTAR™ Neo+ provides highly stable NC performance, enabling highly sensitive and precise results while reducing concerns about test failures caused by NC instability and doubts about the reliability of test results. In addition, the webinar will explain what types of evaluations to perform when switching to recombinant reagents.
The webinar will assess the impact of NC stability on measurement performance and practical usability by presenting an evaluation in which recombinant reagents with different levels of NC stability were prepared and tested. It will also introduce an example of equivalence evaluation against conventional LAL reagents, together with validation data.
What you will learn:
- How recombinant reagents are currently addressed in major pharmacopoeias, and their relevance to existing pharmacopoeial requirements and endotoxin testing standards.
- How recombinant and conventional LAL reagents compare in terms of analytical performance, with test and validation data demonstrating equivalence, and key considerations for method validation.
- The differences between conventional LAL and recombinant reagents, with a focus on the importance of NC stability for assay reliability, result interpretation and the accurate measurement of low endotoxin concentrations.
- The product characteristics and performance of recombinant reagents designed to improve NC stability and support more reliable endotoxin testing.
Case studies will include:
- Extending reagent holding time after reconstitution through NC stabilization.
- Achieving highly sensitive measurement of low-level endotoxin through improved reagent stability.
Register now through your European Pharmaceutical Review membership.
Yannic Werner, EMEA Manager – Pyrogen & Endotoxin Specialist
Yannic Werner studied at the Hochschule Niederrhein in Krefeld, where he completed his Bachelor and Master in chemical engineering. Since 2021, he has been specialized on endotoxin and pyrogen testing as a Sales Manager at FUJIFIM Wako Europe GmbH.
Is the panel discussion free?
Yes – there is no charge to watch the panel discussion, either live or on-demand.
When will the panel discussion take place?
The webinar will be taking place on 11th November 2026 at 3 pm BST.
Can I watch it later?
The panel discussion will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the panel discussion be?
This panel discussion will last up to an hour.
What do I need to watch this panel discussion?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
