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Rapid microbiological methods are being enhanced by artificial intelligence (machine learning in particular). The aim is to speed up analysis; increase accuracy; avoid error and introduce a level of automation. Examples include microscopy, colony counting, and microbial characterisation and matching – each of which is based on improvements in image…
Colleagues Jeremy Peters, Brittany Handzo, Shan Xiao, PhD and Ravi Kalyanaraman, PhD from the Forensics and Innovative Technologies (FIT) group within Global Quality Analytical Science and Technology (GQAS&T) at Bristol-Myers Squibb, present two methods of counterfeit drug determination.
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
This application note presents Raman imaging as a tool for pharmaceutical tablet analysis.
Thermo Scientific™ SampleManager™ XR software enables scientists to work hands free to drive process integrity and compliance.
When you are reviewing bacterial and fungal isolates, do you appreciate that the names given to these organisms are regulated?
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
Discover how GSK and Aragen Biosciences streamlined their processes using various techniques that produced multiple benefits, including increased throughput, improved quality control and reliable automation.
Here, industry experts from bioMérieux Industry, Charles River, Shimadzu, TA Instruments, Thermo Fisher Scientific and WITec share their research, guidance and pharmaceutical knowledge.
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
In this in-depth focus, discover how Raman spectroscopy is used by Bristol-Myers Squibb to identify counterfeit pharmaceuticals and the role of artificial intelligence in rapid microbiological method development.
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
