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Pharmaceutical companies that manufacture tablets, capsules, and other solid dosage forms use film coatings on their products to differentiate appearance and to improve palatability by masking unpleasant tastes or odors.
The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.
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.
I spend a lot of time in bland hotels and rarely remember any of them… except one. This particular hotel will, forever, remain etched on my mind because of the complexity of its toilets.
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.
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).
With the advent of new technology, data integrity−meaning data that is accurate, complete and repeatable−is even more essential to a product's quality and public safety.
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…
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
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.
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.
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.
Reference standards play a critical role in pharmaceutical drug development from preclinical to commercial analytical support.
Companies often need to arrange for the synthesis of test substances to support research and development efforts.
On 23 June 2016, the decision was made on the European Union referendum for the United Kingdom to withdraw from the European Union.
