Walkersville, MD (USA)/Basel (CH), 3 September 2018 – Lonza will reveal its next-generation endotoxin automation solution, PyroTec™ Pro Robotic Solution at the Parenteral Drug Association (PDA) Global Conference on Pharmaceutical Microbiology from 15-16 October, in Bethesda, MD (USA). At Booth #308 Lonza experts will demonstrate how the company's instruments, reagents and software are integrated into the robotic platform, providing a fully automated workflow solution.

Lonza's Next-Generation Robotic Solution for Endotoxin Detection

Consistent with the FDA's Process Analytical Technology (PAT) initiative, Lonza is introducing a new generation of automated endotoxin detection driven by its market leading WinKQCL™ Endotoxin Detection Software.

Attendees of the PDA can see Lonza's PyroTec™ Pro Robotic Solution for endotoxin testing and talk directly to Lonza experts about the innovations in the new WinKQCL™ Software. A few of the highlighted features include:

• Adapting to changes: WinKQCL™ Software can generate robotic scripts and adapt to changing sample dilution requirements.
• Offering a “walk-away” solution: The WinKQCL™ Software can control the procedure from start to finish.
• Saving time and reducing risk: WinKQCL™ Software can import sample test worklists from a sample management system and export the results back out to the same system, preventing transcription errors and saving time over manually entering data.

Poster: The Automation of Endotoxin Testing

During the PDA Endotoxins Workshop that follows the conference on 17-18 October, Lonza will present a new poster demonstrating how automated endotoxin testing can reduce the potential for human error substantially, enhancing the accuracy, reliability and traceability of results.

The presentation will also show how laboratories can maximize their return on investment through the time and cost savings provided by automated endotoxin testing technology.

Titled “The Automation of Endotoxin Testing: Streamlining Your QC Testing with Automated Endotoxin Testing and Process Optimization,” the poster will be presented by Robert Porzio, Product Manager at Lonza. He will explain how Lonza's WinKQCL™ Endotoxin Automation Software Module can revolutionize the way endotoxin testing is being performed, allowing for an overall enhancement of lab efficiency and productivity. In addition to this presentation, Lonza experts will be available at Booth #7 to consult with analysts on how automated endotoxin testing technology can help them streamline their QC testing processes and better monitor endotoxin contamination.

The need for accurate and dependable endotoxin testing technology is greater than ever, with the pharmaceutical industry increasingly focusing on the development of innovative biotherapeutics that carry a higher risk of endotoxin contamination. However, endotoxin testing traditionally involves a number of manual data entry and test template creation steps, which are inherently prone to human error. As a consequence, confidence in results is reduced, the retest rate is increased and the potential for proper second person review of the methods is reduced. Furthermore, the lack of metadata to be associated with manual steps has a negative impact on traceability and the laboratory's audit capability.

As an add-on to Lonza's industry-leading WinKQCL™ Endotoxin Detection Software, the automation module in version 6.0 simplifies the process of setting up an automated endotoxin testing run and requires minimal human intervention while enhancing assay performance. The simplicity of the WinKQCL™ Endotoxin Automation Software Module means that no programming or robotic scripting knowledge is required. Results are automatically read and saved, and can be easily transferred into and out of LIMS, CAPA, MODA or other database systems.

“Our presentation at the Endotoxins Workshop highlights Lonza's commitment to support QC testing labs with solutions that promote data integrity and maximize productivity,” Porzio said. “At the same time, we will have experts on hand at Booth #7 to demonstrate how our wider endotoxin testing product offering can help our customers deliver the next high-quality, breakthrough products.”

PyroTec™ Pro Robotic Solution will be demonstrated:

• On 15 October, from 11:45 am-7:00 pm
• On 16 October, from 9:45 am-4:00 pm
• At Booth #308, in the Exhibit Area of the Bethesda North Marriott Hotel & Conference Center

The poster presentation will be held:

• On 17 and 18 October, from 3:30-4:00 pm
• In the Exhibit Area of the Bethesda North Marriott Hotel & Conference Center
• Lonza experts will be available at Booth #7.

Further information can be found at Lonza Booth #308 at the PDA Global Conference on Pharmaceutical Microbiology 15-16 October or at Booth #7 during the PDA Endotoxins Workshop 17-18 October.