Rapid endotoxin testing for pharma QC
Endotoxins are large molecules found in the outer membrane of Gram-negative bacteria, and can cause fever and pyrogenic shock if they enter the body. Unfortunately, it is hard to control the presence of these bacteria in any environment, even a clean laboratory, making bacterial endotoxin testing (BET) a crucial part of quality control in the pharmaceutical and biomedical industries. Ruth Noé, a Senior Product Manager at Lonza, has been working in this area for 20 years and shares her insights on routine BET.
Need for faster testing
The majority of BET is focused on monitoring the water used in manufacturing, whether it’s a pharmaceutical company producing injectable or intravenous drugs, or a biomedical company manufacturing implantable medical devices. Ruth explained: “Our partners test production waters, raw materials, in-process samples as well as the bulk and final manufactured products to ensure patient safety and regulatory compliance. For pharmaceutical companies, 60-70 percent of all BET is on production waters and, if any contamination is detected, it can impact the final product integrity, so testing needs to be both fast and highly reliable for corrective and preventative action to be taken in a timely manner. Our aim is therefore to help our partners ensure that they meet the regulatory requirements while mitigating contamination risk in their processes, by providing solutions to simplify and accelerate ‘right-first-time’ testing.”
Automation is the obvious solution to this challenge, and Lonza wanted to build on the success of its early PyroTec® Platform – a Freedom EVO®-based system mainly used in the dialysis market – by creating a fully automated integrated BET system for mid-sized pharma and biotech companies around the world performing QC testing in GMP environments. Ruth continued: “Considering that we had such a great experience working with the Tecan Synergence™ team on the original PyroTec® System, it was an obvious choice to turn to them again when we started developing our new platform. The PyroTec® PRO Automated Solution is based on Tecan’s Freedom EVO® 150 workstation with both a Liquid Handling Arm™ and a Robotic Manipulator Arm™, streamlining the liquid handling processes and allowing the users to replace manual benchtop endotoxin detection protocols with a fully automated workflow.”
Software plays an important role in any automation process and a lot of efforts were made – both by Lonza’s own software developers and the Tecan team – to create a dynamic scripting interface that allowed customers to select the assay template, populate the deck, click go, walk away and come back to results later. Ruth continued: “This new interface connects our market-leading WinKQCL® Endotoxin Detection & Analysis Software with the robotic system, providing a user-friendly, fully integrated automated solution to help our customers increase the productivity of their BET workflows. All the data – both from automatic and manual processes – can be stored and managed through a central database, and accessed by any authorized individual within the company, streamlining data management and giving our customers greater flexibility.”
“Working with Tecan is always a pleasure; the team helps us keep our customers happy by providing support throughout the whole process, starting at the initial installation, up to the documentation and compliance. Moving forward, we have a clear product development roadmap for our BET portfolio with Tecan, including the possibility of future system iterations based on new decks, platforms and readers,” concluded Ruth.