Widening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
Automating a Laboratory’s BET workstream using Lonza’s PyroTec® PRO Robotic Solution, WinKQCL® Software, and MODA® Software.
12 March 2024 | By Actylis
Join us as we look at how the outsourcing of buffers is helping biopharma drug manufacturers to streamline their processes.
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for nearly 50 years.
Interested in scientifically sustainable endotoxin testing? Discover more about Endosafe® Trillium® recombinant cascade reagent (rCR)
Our dedication to quality and prompt service has earned us several awards. You can trust us for top-notch service and reliability.
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
USP’s proposed new Chapter < 86 >, which offers additional information on Bacterial Endotoxins Tests (BETs) using non-animal derived reagents, has been published as a General Announcement in advance of public consultation.
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.