Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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.
Bringing a wealth of structural information and direct quantification to the lab or plant, the Fourier PAT benchtop NMR reduces tedious calibrations and increases (bio)process understanding and control, hence further reducing risks and cost.
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
15 February 2024 | By European Pharmaceutical Review, sponsored by Mettler Toledo and Bruker
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
The approach applied in the research on bioreactors represents a significant advancement over traditional methods, according to the researchers.
9 February 2024 | By Charles River Laboratories
Join this webinar to unravel the complexities of microbial identification technologies and their pivotal role in fortifying contamination control strategies within the pharmaceutical industry.
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
An effective analytical framework for a broad spectrum of monoclonal antibodies (mAbs) and complex mAb biotherapeutics has been developed, according to a recent study.
An ultra-high sensitivity and super-resolution infrared imaging technique for single proteins could lead the way to a multitude of applications using infrared nanospectroscopy.
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and…
4 January 2024 | By bioMérieux
Watch this webinar on demand to learn how InDevR and their VaxArray multiplexed immunoassay platform empower Critical Quality Attribute (CQA) testing for multivalent mRNA vaccines.