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Why Pyrogen and Sterility Testing Matters
Ensuring microbial safety is fundamental to every therapeutic modality. As advanced therapies, evolving regulatory expectations, sustainability initiatives, and rapid microbiological methods reshape quality control, laboratories need testing solutions that deliver both scientific confidence and operational efficiency.
From recombinant endotoxin assays and Monocyte Activation Tests (MAT) to rapid sterility technologies, FUJIFILM Biosciences provides a comprehensive portfolio of pyrogen and sterility testing solutions that support regulatory compliance, accelerate release decisions, and safeguard product quality across biopharmaceutical development and manufacturing.
Solutions by Product Type
Solutions by Product Type
Reagents
A comprehensive portfolio of endotoxin and pyrogen detection and sterility test reagents, including:
Endotoxin-specific LAL Reagents
Reagents for gel-clot, kinetic turbidimetric assay (KTA), and kinetic chromogenic assay (KCA)
Recombinant Endotoxin Detection Reagent
Reliable, animal-free solutions for modern quality control
Monocyte Activation Test
Detect pyrogens beyond endotoxins
Peptidoglycan and β-Glucan Specific SLP Reagents
Quantitative determination of peptidoglycan (PG) and (1->3)-β-D-glucan in parenteral solutions and active pharmaceuticals
Sterility Testing
Rapid sterility testing solution enabling faster results compared to conventional methods
Analysis Systems
Detection systems designed to support accurate and efficient workflows:
Endotoxin Analysis Systems
User-friendly analysis system and software capable of performing all methodologies of LAL testing
Accessories and Controls
Supporting tools and consumables to ensure consistency and reliability:
Accessories
Control, buffer solutions, endotoxin-free consumables for clean, reliable endotoxin testing workflows
Explore by Modality
Cell Therapy
Interference-resistant BET for complex cell products
Antibody Therapeutics
High-throughput testing for biologics manufacturing
Gene Therapy
Sensitive detection for viral vectors
Featured Solutions
Featured Solutions
Animal-free recombinant endotoxin detection reagents for high-sensitivity, endotoxin-specific assays
In vitro test that detects both endotoxin and non-endotoxin pyrogens
Rapid sterility testing solution delivering results in as little as seven hours
Fully integrated LAL testing system for rapid and sustainable endotoxin testing in under half the time as other methods
Advance your testing strategy with solutions designed for today’s biologics
Featured Articles
Mitigating At-Risk Cell and Gene Therapy Application with Rapid Sterility Testing
About Us
Our Commitment to Horseshoe Crab Conservation
The ethical treatment of the Atlantic horseshoe crab is of top priority during the development of our Limulus amebocyte lysate (LAL) reagents. In addition to numerous steps taken to care for horseshoe crabs while in the hands of our ecological and technical teams, Fujifilm has developed and is actively participating in several proactive and aggressive conservation initiatives.
Our overall goal is to protect and monitor the crabs while in our care. Lifelong fishermen carefully gather the crabs and bring them safely to our facility. During their short time out of the sea, the crabs are thoroughly inspected by our team of highly-trained professionals to ensure that each one appears healthy and is free from trauma. Our procedures are conducted with the utmost care and diligence to prevent any injury to the donor crabs, and our fishermen always return them to the same waters from which they were collected.
Recently, our company has expanded efforts to protect these amazing animals by joining several other prestigious ecological conservation groups and organizations. This includes supporting The Horseshoe Crab Conservation Fund, which is committed to the long-term protection of these crabs through community projects and educational outreach programs. Additionally, we work closely with the U.S. Fish and Wildlife Service in a horseshoe crab tagging and monitoring program to better understand their habits and migration patterns in order to ascertain whether or not biomedical processes have any impact on the crabs.
Fujifilm is dedicated to the care and protection of horseshoe crabs. By developing and creating new educational programs, we are able to share the incredible story of these important animals and their contributions to medicine and the ocean's ecosystem.
The ethical treatment of the Atlantic horseshoe crab is of top priority during the development of our Limulus amebocyte lysate (LAL) reagents. In addition to numerous steps taken to care for horseshoe crabs while in the hands of our ecological and technical teams, Fujifilm has developed and is actively participating in several proactive and aggressive conservation initiatives.
Our overall goal is to protect and monitor the crabs while in our care. Lifelong fishermen carefully gather the crabs and bring them safely to our facility. During their short time out of the sea, the crabs are thoroughly inspected by our team of highly-trained professionals to ensure that each one appears healthy and is free from trauma. Our procedures are conducted with the utmost care and diligence to prevent any injury to the donor crabs, and our fishermen always return them to the same waters from which they were collected.
Recently, our company has expanded efforts to protect these amazing animals by joining several other prestigious ecological conservation groups and organizations. This includes supporting The Horseshoe Crab Conservation Fund, which is committed to the long-term protection of these crabs through community projects and educational outreach programs. Additionally, we work closely with the U.S. Fish and Wildlife Service in a horseshoe crab tagging and monitoring program to better understand their habits and migration patterns in order to ascertain whether or not biomedical processes have any impact on the crabs.
Fujifilm is dedicated to the care and protection of horseshoe crabs. By developing and creating new educational programs, we are able to share the incredible story of these important animals and their contributions to medicine and the ocean's ecosystem.
Contribution to Measurement Technology
- Acquisition of FDA approval
https://labchem-wako.fujifilm.com/asia/lal/lal_system/lal_technology.html
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Explore Testing Solutions by Modality
| Challenges | Solutions | |
 Safety Risks |
Increasing sensitivity requirements to ensure samples are free from endotoxin and sterility threats | High-sensitivity assays that detect pyrogens beyond endotoxins and meet the stringent requirements of modern quality control (QC) guidelines |
 Complex Matrices |
Challenging biological samples can interfere with conventional assays—making testing more difficult, especially in recent cell-based advanced therapies | Solutions that address all methodologies of pyrogen and sterility testing with limited assay interference |
 Speed to Release |
Accelerated timelines create pressure to reduce turnaround and get products to patients faster | Rapid testing solutions and high-throughput methodologies that accommodate a larger number of samples and deliver results in less time without sacrificing accuracy |
Solution by Product Type
Applications Beyond the Pharmaceutical Landscape
Additional Applications
While advanced biologics present unique challenges, pyrogen and sterility testing remains essential across a wide range of pharmaceutical and industrial applications. Our solutions also support testing requirements in more established and high-volume environments—where reliability, compliance, and efficiency remain critical.
Implantable Medical Devices
Pyrogen and Sterility Testing for Medical Device Quality Control
