- In March 2024, Lonza Group announced the expansion of its endotoxin and pyrogen testing capabilities by launching a new recombinant factor C (rFC)-based assay kit. This development aligns with growing regulatory acceptance of animal-free testing methods and supports sustainability goals by reducing reliance on horseshoe crab blood
- In February 2024, Charles River Laboratories introduced enhanced Monocyte Activation Test (MAT) platforms through automation integration, aiming to improve the throughput and reproducibility of pyrogen detection in biologics and cell therapies. The innovation is targeted at streamlining workflows for pharmaceutical companies complying with stringent global regulations
- In January 2024, FUJIFILM Wako Chemicals USA Corporation upgraded its Limulus Amebocyte Lysate (LAL) reagent portfolio with increased sensitivity and reduced variability, enhancing the reliability of endotoxin testing in parenteral drugs and medical devices. The company also announced new distribution partnerships to expand its reach across Southeast Asia
- In December 2023, Associates of Cape Cod, Inc. (ACC) received additional approvals from Asian regulatory authorities for its PyroSmart NextGen rFC assay. The approval is expected to accelerate the adoption of sustainable, animal-free endotoxin testing methods across biopharma manufacturers in Japan, China, and South Korea
- In October 2023, Merck KGaA (MilliporeSigma) introduced a new high-throughput turbidimetric endotoxin testing solution designed for vaccine and biologics production. The launch is part of the company’s initiative to support faster lot-release testing while meeting evolving GMP standar
- In September 2023, Thermo Fisher Scientific revealed the development of an integrated LAL test automation platform in collaboration with global CDMOs. This solution combines LAL testing with real-time data capture, aiming to reduce human error, improve efficiency, and ensure audit-readiness in regulatory submissions
