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Technical note: System precision in HPLC analysis of APIs and impurities
HPLC users expect robust, reliable systems with equivalent performance and reproducibility between systems that greatly facilitates method transfer.
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Analytical techniques
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Event review: The Future of QA/QC for Complex Biologics
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
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Enhancing rapid microbiology methods: how AI is shaping microbiology
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…
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Counterfeit classifications using Raman spectroscopy and visible near-infrared (VNIR) hyperspectral imaging
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.
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Critical steps when validating an assay or analytical method for cell and gene therapy products
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.
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Application note: Analysing pharmaceutical tablets with confocal Raman imaging
This application note presents Raman imaging as a tool for pharmaceutical tablet analysis.
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Application note: Achieve complete lab access with extended reality LIMS software
Thermo Scientific™ SampleManager™ XR software enables scientists to work hands free to drive process integrity and compliance.
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Application note: An alternative method of drug‑excipient characterisation
An alternative test method that enhances detection of incompatibilities by significantly reducing testing time, improving testing throughput and reducing operator effort.
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Application note: Comprehensive fractionation of herbal medicine components by PDA-ELSD-triggered preparative LC
This article introduces a comprehensive fractionation method for both UV absorbing and non-UV absorbing compounds.
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Application note: Taxonomic traceability for bacterial and fungal entries in Accugenix® reference databases
When you are reviewing bacterial and fungal isolates, do you appreciate that the names given to these organisms are regulated?
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Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
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Product hub: 3P® connect EM-BODY connectivity
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
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Enhancing efficiency and economics in process development and biotherapeutics
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.
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Application Notes Supplement 2021
Here, industry experts from bioMérieux Industry, Charles River, Shimadzu, TA Instruments, Thermo Fisher Scientific and WITec share their research, guidance and pharmaceutical knowledge.
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Bioprocessing & Bioproduction In-Depth Focus 2021
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.
