FUJIFILM Wako Pure Chemicals Launches New Pyrogen and Endotoxin Tests
2024年6月27日 - 10:00PM
FUJIFILM Wako Pure Chemicals Corporation announces the launch of
two new tests: LumiMAT™ Pyrogen Detection Kit (LumiMAT), a
next-generation monocyte activation test (MAT)*1 for in vitro*2
pyrogen testing, and PYROSTAR™ Neo+, a recombinant protein reagent
for the detection of bacterial endotoxins. Alternatives to
traditional pyrogen and endotoxin tests, the new LumiMAT and
PYROSTAR™ Neo+ testing kits will be available worldwide in July
2024.
Pyrogens, including gram-negative bacterial
endotoxins, are substances which produce fever, inflammatory
reactions, and, in extreme cases, death,*3 when introduced into the
bloodstream. Guidelines require that parenteral biological
products, drugs, and medical devices that come in contact with the
blood stream are tested for pyrogens.
Developed as an alternative to the rabbit
pyrogen test, LumiMAT screens several cell lines*4 and is a rapid,
robust, and highly sensitive assay for the detection of pyrogens,
offering several advantages over traditional MAT assays currently
available on the market. Most commercially available MAT assays
utilize peripheral blood mononuclear cells (PBMCs)*5 to measure
cytokines released by monocytic cells upon exposure to pyrogens via
ELISA,*6 and can result in lot-to-lot variation and long testing
times (up to 1.5 days). In contrast, LumiMAT uses human NOMO-1
cells*7 selected in a screen based on their high sensitivity to
lipopolysaccharide (LPS) and a wide range of non-endotoxin
pyrogens, as well as their reproducibility and stability. In
addition, LumiMAT utilizes a luciferase reporter assay*8 to detect
activation of the transcription factor NF-κB,*9 producing results
in approximately 5 hours. The European Pharmacopoeia recently
announced plans to replace the rabbit pyrogen test by 2026, with a
clear preference for the MAT.
PYROSTAR Neo+, a recombinant protein-reagent for
the detection of gram-negative bacterial endotoxin utilizes the
Kinetic Chromogenic Assay (KCA)*10 to measure endotoxin content.
The reagent is composed of recombinant Factor C, Factor B, and a
proclotting enzyme, allowing for endotoxin detection that offers
the same sensitivity as the traditional LAL*11 reagent. In
addition, PYROSTAR Neo+ shows reduced interference with some drugs
and improved reactivity to naturally occurring endotoxins, enabling
use in a wider range of samples and applications, including product
safety assessment and testing of pharmaceutical materials and water
used for their manufacture.
“With a longstanding history contributing to
public health and patient safety through quality control testing
solutions for pharmaceuticals, we are proud to introduce two new
testing kits for pyrogens and endotoxins to lead the industry
forward,” said Koichi Yoshida, president of FUJIFILM Wako Pure
Chemicals Corporation. “Our robust lineup of testing kits provides
options for the pharmaceutical and medical device industries to
choose the appropriate kit for their application. We will continue
to help ensure the safety of healthcare products for patients
around the world.”
LumiMAT™ uses NanoLuc® technology; NanoLuc®
technology is licensed from Promega Corporation. Licensed Patents:
U.S. Pat No. 8557970 and U.S. Pat. No. 8669103, and all patents and
patents pending which claim priority to the same priority
application(s) as U.S. Pat. No. 8557970 and U.S. Pat. No.8669103.
NanoLuc® is a registered trademark of Promega Corporation.
1 A test to detect pyrogenic (fever-causing)
substances based on the activation of human monocytes and the
release of inflammatory cytokines in response to exogenous
endotoxins and non-endotoxin pyrogens.2 A test performed on human
or animal cells or tissues in a culture vessel or other medium.3
Solati S., Zhang T., Timman S. (2022). The monocyte activation test
detects potentiated cytokine release resulting from the synergistic
effect of endotoxin and non-endotoxin pyrogens. Innate Immun
28(3-4), pp. 130-137. PMID: 35491666.4 Cell lines are permanently
established cells that can be stably grown and cultured for a long
period of time.5 Mononuclear cells isolated from peripheral blood,
including lymphocytes (T cells, B cells, NK cells) and monocytes.
In humans, lymphocytes constitute the majority of the PBMC
population.6 Enzyme-Linked Immuno-Sorbent Assay, an immunological
assay commonly used to measure antibodies, antigens, proteins, and
glycoproteins in biological samples using an enzymatic reaction.7
Human monocytic leukemia cell line.8 A test method used to
determine if a substance can activate or repress the expression of
a target gene. In the LumiMAT assay, pyrogenic substances are
detected and quantified using reporter cells in which binding of
pyrogenic agents to the Toll-like receptor (TLR) activates NF-κB
and induces expression of luciferase protein.9 Nuclear Factor kappa
B, a transcription factor that regulates the expression of genes
involved in immune and inflammatory responses.10 A method for
detecting endotoxin content, this assay measures color development
that results from the breakdown of a substrate in the reagent
caused by reaction with endotoxin.11 Limulus Amebocyte Lysate, a
reagent for endotoxin assay.
About
Fujifilm FUJIFILM Wako Chemicals U.S.A.
Corporation, headquartered in Richmond, Virginia, is recognized
around the world as a trusted supplier of high purity chemicals and
reagents for the Specialty Chemicals, Laboratory Chemicals, and
Diagnostics business sectors. The company offers a wide range of
products including the PYROSTAR™ ES-F series of reagents and the
Toxinometer® ET-7000 measurement system, a computer-operated
kinetic incubating tube reader, to help its customers detect
endotoxins. FUJIFILM Wako Chemicals U.S.A. Corporation develops and
sells products dedicated to the health, welfare, and safety of its
customers, as well as the protection of the environment. For
more information, please visit:
https://www.wakopyrostar.com.
FUJIFILM Corporation is a subsidiary of FUJIFILM
Holdings Corporation. FUJIFILM Holdings Corporation, headquartered
in Tokyo, leverages its depth of knowledge and proprietary core
technologies to deliver innovative products and services across the
globe through the four key business segments of healthcare,
electronics, business innovation, and imaging with over 70,000
employees. Guided and united by our Group Purpose of “giving our
world more smiles,” we address social challenges and create a
positive impact on society through our products, services, and
business operations. Under its medium-term management plan,
VISION2030, which ends in FY2030, we aspire to continue our
evolution into a company that creates value and smiles for various
stakeholders as a collection of global leading businesses and
achieve a global revenue of 4 trillion yen (29 billion USD at an
exchange rate of 140 JPY/USD). For more information, please visit:
www.fujifilmholdings.com.
For further details about our commitment to
sustainability and Fujifilm’s Sustainable Value Plan 2030, click
here.
- MAT Method Operation Flow
- PYROSTAR NEO+
Daniel Carpenter
FUJIFILM Holdings America Corporation
9145292417
daniel.carpenter@fujifilm.com