Where Science Meets Inspiration
01 - 03 June 2020, Baltimore, MD & Pickering Beach, DE, USA
01 - 03 June 2020, Baltimore, MD & Pickering Beach, DE, USA.
01 - 03 June 2020, Baltimore, MD & Pickering Beach, DE, USA.
USD 1,300 early bird rate. Register by 30 April 2020
USD 1,500 as of 01 May 2020
Registration is required for our 2020 Endotoxin Summit
Academic and government discounts are available.The registration fee includes participation in the Summit, meals throughout the meeting, associated activities, as well as travel to and from Pickering Beach, DE. Registration fee does not cover costs for travel to the summit venue or hotel accommodations.
Renaissance Baltimore Harbor Place Hotel
202 E. Pratt Street, Baltimore, MD 21202
We have arranged a group rate at the hotel. Attendees can make reservations directly with the hotel.
Do you have questions? Email us your inquiry.
The need for accurate and dependable bacterial endotoxin testing technology is greater than ever, especially with the pharmaceutical industry increasingly focusing on the development of innovative biotherapeutics that carry a higher risk of contamination. In response, the industry is looking to improve current workflows, and now novel automated methods are emerging that show great promise for advancing endotoxin testing. Indeed, the new methods can improve laboratory efficiency and productivity, and enhance data integrity, to drive faster and more reliable delivery of high-quality, safe drugs to patients. Here, we draw from key insights shared during Lonza’s 5th annual Global Endotoxin Testing Summit to discuss the limitations associated with manual endotoxin testing methods and highlight the benefits of automation.
Using the Limulus Amebocyte Lysate (LAL) method to test parenteral pharmaceuticals and medical devices for bacterial endotoxin contamination has traditionally involved a long series of manual steps. While speaking at this year’s summit, Dr. Jan Erik Rau, Head of QC Microbiology and subject matter expert for Microbiology at Lonza Visp, Switzerland, explained that these steps include, but are not limited to, preparing, vortexing, pipetting and transferring standards, samples and sample dilutions.
“As with all procedures that rely on human intervention, these steps are inherently error-prone and can lead to a number of problems, including sample mix-up and loss” said Rau. “Eventually, obtaining a new sample and repeating the test may be needed. The entire analytical process becomes even more challenging when it comes to handling complex, viscous samples, which are fundamentally difficult to weigh and transfer due to their thick, sticky nature.”
On the whole, manual endotoxin testing is a long, laborious and tedious process, which negatively impacts laboratory efficiency and productivity. To overcome these challenges, QC laboratories typically employ highly trained personnel who have the necessary knowledge and expertise to perform the manual tasks to a high standard, reducing the error potential to a minimum. However, given how time-consuming the manual endotoxin testing process can be, this can lead to a significant drain on scientists, who would otherwise focus on more essential tasks, such as reviewing the results to expedite the release of new, life-saving therapeutics.
Modern automated endotoxin testing systems, such as Lonza’s PyroTecTM PRO Automated Robotic Solution, are designed to simplify and accelerate the detection of bacterial endotoxins in parenteral pharmaceuticals and medical devices. As a result, pharmaceutical companies can expedite the delivery of safe medicines to improve patient healthcare. By minimizing human intervention, automated systems also reduce the ergonomic strain associated with high pipetting workloads and free up experienced laboratory staff to undertake other projects.
“The hands-on-time per sample is decreased significantly,” Rau remarked. “Automated solutions guide users through the selection of an appropriate template from an existing library, as well as, through the set up of the robot deck layout. The analyzer then automatically runs the entire assay, from sample dilution to microplate reading, and saves the results in the instrument’s built-in software, such as Lonza’s WinKQCLTM Endotoxin Detection and Analysis Software. Some of the most powerful automated systems are able to process double the samples compared to manual methods within an equivalent timeframe.”
Automated endotoxin testing systems also seamlessly connect with LIMS and other paperless data processing solutions, such as Lonza’s MODATM Solution. These platforms have the ability to capture metadata for full traceability of the sample lifecycle, and to facilitate tracking, trending and audit control. The need for the manual transcription of data is eliminated, thus reducing the potential for human error and bias substantially, while saving valuable time. Scientists at QC laboratories can therefore feel confident that the generated results are accurate, consistent and reproducible, and so can be relied upon to drive informed decisions about moving a product to the next stage in the development process. Moreover, the need to repeat analytical runs is also minimized.
For many years, manual, resource-intensive endotoxin testing workflows have placed a considerable burden on pharmaceutical developers and manufacturers, compromising laboratory efficiency and productivity, as well as data integrity. However, scientific practices are always subject to refinement — a constant strive to find better ways of doing things — and endotoxin testing is no exception. As such, automated endotoxin testing technology has emerged to overcome the challenges of manual methods.
Dr. Rau offered his insights at this year’s summit: “Automated endotoxin testing systems are designed to streamline analytical workflows, boost laboratory productivity and enhance data integrity, allowing for the quicker generation of results to deliver novel and safe therapies to patients faster. This year’s summit offered a unique opportunity for both endotoxin testing scientists and end-users to discuss the latest developments in the field and witness how automation is the way forward.”