Reading Scientific Services Ltd (RSSL) has become the first UK laboratory to offer a sustainable bacterial endotoxin test (BET) method to the life sciences industry.
The move will see RSSL offer PyroSmart NextGen™, an innovative, sustainably-produced, recombinant cascade reagent (rCR) for key BET applications, such as testing of water, injectable drugs, vaccines and medical devices. It comes in response to growing industry demand for a reliable and effective alternative to the longstanding practice of using LAL reagents derived from horseshoe crab blood for endotoxin testing.
“We are delighted to be leading the way in terms of providing a more sustainable option for BET in the UK. It gives us the opportunity to move away from traditional reliance on animal-derived reagent materials - and associated ethical and ecological concerns - but without compromising either the quality or reliability of the resulting test data. As such, this new technology is very much aligned with RSSL’s drive to adopt more sustainable business practices wherever possible,” said Reginald Fernandes, Life Sciences Microbiology Manager at RSSL.
PyroSmart NextGen™ is the result of years of research and development by leading endotoxin detection specialists, Associates of Cape Cod Inc. It follows the same enzymatic cascade pathway as naturally-sourced reagents and can be used as a direct, synthetic replacement. Unlike first generation recombinant reagents, there is no need to change test methods and purchase new specialised instrumentation.
RSSL has also created a level playing field when it comes to method validation, as Fernandes explains:
“Given this new technology has only recently been launched, it is currently only recognised as an alternative method by the Pharmacopoeia. Although we do expect this position to change in the future, it does mean that further validation to prove equivalence will initially be required in order to meet regulatory requirements. As we do not want this to act as a barrier, RSSL are here and ready to support carrying out the necessary additional steps to help our clients meet their sustainability goals.”
For further information about this service or to discuss your requirements with one of our team, please click here or call 0118 918 4076.
NOTES TO EDITOR:
About Reading Scientific Services Ltd (RSSL)
RSSL: Reading Scientific Services Ltd is a global leader at the forefront of scientific analysis, consultancy, product development and training, serving the food, drink, pharmaceutical, healthcare, biopharmaceutical and consumer goods industries.
For more information, please visit www.rssl.com or follow RSSL on LinkedIn.