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Application Note: Quality manufacturing solution – interfacing with third-party systems
Most organisations that are looking to implement a new LIMS or replace an aging one have a significant investment in a number of information systems.
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Analytical techniques
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Application Note: Transforming your bioanalysis operations
Many bioanalytical labs work with a crowded and siloed set of systems and processes. From part electronic to part paper-based workflows, to standalone point-solutions, the result is a lack of insight into data and slower reporting and results handling.
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Whitepaper: Characterising antibody-drug conjugates using micro pillar array columns combined with mass spectrometry (μPAC™-MS)
The use of micro pillar array columns (μPAC™) for characterising antibody-drug conjugates is presented. Kadcyla® (ado-trastuzumab emtansine) and, for comparison, Herceptin® (trastuzumab) tryptic digests were analysed on a 200 cm μPAC™ C18 column and peaks eluting were detected by ultraviolet (UV) spectroscopy and high-resolution mass spectrometry (MS).
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Whitepaper: Big Data in pharmaceuticals – big opportunities or big challenges or both?
Big data covers every facet of our working life. Every aspect of pharmaceutical research and development involves the generation of huge quantities of data, with the expectation that we can turn this information rapidly into useful knowledge, which in turn can be used to make ‘data-driven’ decisions to better understand…
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Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
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Application Note: Representative sampling of solids and turbid media in process raman spectroscopy
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation. As a measurement technique, Raman imparts many benefits in applications from laboratory discoveries to feedback-control in manufacturing.
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Application Note: Tracking fate and purge of impurities and calculating carryover
The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.
news
Sprayable gel with CD47 blockers could be the future of drug delivery for cancer
A sprayable gel containing calcium carbonate nanoparticles with antibodies targeted to block CD47, could be the future of drug delivery for cancer...
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Scientific Poster: How complementary chromatographic methods can support a full analytical picture in pharmaceutical drug development
HPLC is a rapid, accurate and sensitive method for determination of pharmaceutical drugs, degradations and impurity profiling. It is a preferred method for analytical characterisation during drug development.
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Tailored treatment for acute myeloid leukaemia
The screening of leukaemia cells for drug susceptibility and resistance are bringing scientists closer to patient-tailored treatment for AML...
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Oxybutynin improves quality of life for breast cancer survivors
Oxybutynin could help breast cancer survivors who are affected by increased hot flushes through cancer treatment, improving their quality of life...
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Five more countries to join EMA-FDA mutual recognition
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...
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PET tracer able to image tau in Alzheimer’s disease patients
Research into detecting tau proteins in the brains of Alzheimer's patients has shown that a specific tracer could detect and measure the protein levels...
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Phase III KATHERINE trial crossed early reporting boundary and met its primary endpoint
A phase III clinical trial showed that neoadjuvant chemotherapy and trastuzumab reduced the risk of recurrence of HER2-positive early-stage breast cancer...
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Trastuzumab taken with carvedilol leads to less heart damage
A team of Iranian researchers have determined that trastuzumab taken with a heart drug leads to less heart damage in breast cancer patients...
