Tag Archive: drug development

May 26

Accurate MIC endpoints with automation

LGC-Anti-infective-drug-development_services

LGC’s drug development team regularly assess new methods to refine and strengthen our existing analytical services across all disciplines.   An old-school stalwart of microbiology testing, minimum inhibitory concentration (MIC) testing identifies the lowest concentration of a substance that prevents visible growth of a bacterial strain.   The MIC is the bacteria’s tipping point and …

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Jan 31

10 million people will die of bacterial infections in 2050, and each year after that

  Article by: Ed Siegwart    Antibiotic awareness European Antibiotic Awareness Day (EAAD) took place on 18 November, in the middle of World Antibiotic Awareness Week and reminded us of the shocking statistic that if no new antibiotics are successfully developed then 10 million people will die of bacterial infections in 2050, and each year after …

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Dec 12

Foreign particulate matter in pharmaceuticals

There has been a recent rise in the number of pharmaceutical product recalls due to the presence of Foreign Particulate Matter (FPM), and its effect on product efficacy and safety. FPM is either inherent (from the product itself), intrinsic (from the production process), or extrinsic (contaminating particles from outside). There is a regulatory requirement for …

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Apr 26

In vitro antimicrobial efficacy testing: potential pitfalls and future methods

LGC supports the antimicrobial drug pipeline

Antimicrobial resistance (AMR) is a global issue, which already causes significant loss of life and will continue to get worse as further resistance evolves. By 2050, it is anticipated that due to AMR alone, 10 million people will die each year, more than currently die from diseases like cancer.   Antimicrobial drug pipeline One of …

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Apr 14

LGC can help develop new medications

This week saw World Parkinson’s Day and Dr Christian Zeine from our Standards team has been sharing his thoughts on how we are able to help develop new medications to treat this chronic and progressive disorder. “With current medical knowledge, Parkinson’s can be treated effectively, but there is no final cure at this stage. Well known …

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Feb 18

Quantitation of low level impurities using LC-MS/MS in GMP analysis

Register for the LGC webinar on In vitro antimicrobial efficacy testing

LC-MS/MS has been the technique of choice for trace organic analysis in most areas of analytical chemistry for over a decade and is now slowly but steadily becoming so in GMP pharmaceutical analysis. LC-MS/MS offers unrivalled sensitivity and selectivity as well as speed of analysis. The technique is able to routinely quantify down to the …

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Jan 22

Little to LARGE: LC-MS/MS peptide method development for small molecule specialists

The development of LC-MS/MS methods for the quantitation of large molecules within biological matrices can help to overcome some of the challenges associated with immunoassay-based analyses. For example, the need to raise new antibodies against novel analytes, poor specificity due to cross reactivity with similar compounds, and for radioimmunoassays the additional safety considerations. LC-MS/MS method …

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Jul 10

Supercharging reagents – revving up peptide LC-MS analyses

Over the past 5 years, LC-MS has (arguably) become the technique of choice to quantify peptides in biological matrices. The benefits of using LC-MS as a quantitative technique are significant, however, there is one drawback – low sensitivity. The acquisition of multiple numbers of charge states for peptides in the MS source can result in …

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May 15

ICH Q3D elemental impurities testing: are you prepared for the new ICH/USP regulatory guidelines?

As a consequence of the new ICH/USP regulatory guidelines concerning testing of elemental impurities the way in which pharmaceutical companies and their suppliers will be required to test their APIs and excipients will change dramatically. The guidelines, which aim to set out a global policy for limiting metal impurities in drug products and ingredients puts …

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Mar 20

Ultrasensitive immunoassays using single molecule counting technology

Traditional ELISA-based immunoassays have struggled to determine baseline endogenous concentrations for many biomarkers. The Erenna® Immunoassay System is based on the same principles as a plate-based sandwich ELISA but offers 50-1000 fold greater sensitivity through a combination of microparticle bead (MB) capture and single molecule counting of fluorescently labelled detection molecules. MB’s have the dual …

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