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.
List view / Grid view
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.
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
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)
In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
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.
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…