Drug safety driving pyrogen testing market expansion
A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
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A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
Leveraging next-gen technologies such as NLP in data ingestion and extraction, can enable systems to seamlessly extract and analyse such free texts.
An alternative in vitro pyrogen detection test using transfected THP-1 cells detected endotoxin and nonendotoxin pyrogens with good sensitivity, stability and predictability, a study shows.
22 March 2024 | By Rapid Micro Biosystems
Discover the extensive panel testing done to evaluate the new, innovative sterility testing platform, Growth Direct® Rapid Sterility.
According to the paper, the control strategy for rapid bioburden testing provides manufacturers with enhanced capabilities for process control.
This ebook explains how single-use filtration can support safer, more efficient biopharmaceutical production. Discover more on different filtration stages and unveil key characterisations, like pore size and membrane material, empowering tailored selection to specific biomolecules and processes.
Research suggests that to prevent common mould growth, low-dose far-UVC light could be applied as a chemical-free addition to manual cleaning of indoor surfaces.
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.
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
Automating a Laboratory’s BET workstream using Lonza’s PyroTec® PRO Robotic Solution, WinKQCL® Software, and MODA® Software.
The new sterilisation method could provide an affordable, rapid approach for preparing microbiological culture media, research suggests.
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
In this Q&A, data expert Joseph S Boakai addresses decisive factors impacting data integrity in the pharma and life sciences industries.