OEM SYSTEM DEVELOPMENT
A sure BET for workflow automation Bacterial endotoxin testing (BET) is an important quality control check for the pharmaceutical and biomedical industries, ensuring that injectable or intravenous drugs and implantable medical devices are safe to use. Lonza offers a wide range of reliable BET solutions for QC labs, including high throughput, automated systems for microplate-based endotoxin detection.
Endotoxins are large molecules found
Automation is the obvious solution to
in the outer membrane of Gram-
this challenge, and Lonza wanted to
negative bacteria, helping the bacteria
build on the success of its early PyroTec®
to survive in harsh environments. This
Platform – a Freedom EVO®-based
role in nature makes the presence of
system mainly used in the dialysis
endotoxins difficult to control in a
market – by creating a fully automated,
laboratory environment, as they are
integrated BET system specifically for
resistant to extreme conditions,
QC activities in the pharmaceutical and
including high heat and chemical
biomedical sectors. Ruth continued:
treatments. Unfortunately, when
“The PyroTec® PRO Automated Solution
present in ng/kg concentrations in
offers users the ability to move away
vivo, endotoxins can cause symptoms
from manual benchtop endotoxin
such as fever and pyrogenic shock,
detection protocols to a fully automated
making it essential that parenteral
workflow. It has been developed from
medicines – drugs using non-oral
the outset for mid-sized pharma and
means of administration – vaccines and
biotech companies around the world
implantable medical devices are
performing QC testing in GMP
routinely tested for the presence of
environments, where reliable
endotoxins during production. Ruth
technology and strong support are
Noé, a Senior Product Manager at
critical. Many of these customers are
Lonza, has been working in this area
already using manual, plate-based
for 20 years, and explained the
testing solutions, and might have
process: “Our partners test production
automated other processes in areas like
waters, raw materials, in-process
chemistry, so it’s a natural progression.”
samples and manufactured products to both meet the regulators’ requirements and to mitigate contamination risk in their processes. For pharmaceutical companies, around 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.”
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TECAN JOURNAL 2/2021
