Whitepaper: The importance of data integrity in current regulation
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.
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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.
Oligonucleotides must be of high purity when used in molecular biology applications, but efficient purification over a large range of production scales is challenging. The Gilson GX-271 Oligonucleotide Purification System provides a versatile solution for continuous separation, analysis, and desalting of oligonucleotides...
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The CPhI Annual Report is a comprehensive and critically important publication that analyses key trends and innovations forecast by our panel of world class experts. Running as a series of opinions and articles, the CPhI experts call upon their considerable commercial and technical acumen to prophesize the future direction, technologies,…
The advent of High Performance Liquid Chromatography (HPLC) has revolutionised analytical chemistry, greatly enhancing not only the speed of column chromatography, but also the separation and identification capacity of analytes...
Infliximab, commercially known as Remicade, is a chimeric IgG1 kappa monoclonal antibody (mAb), that targets tumor necrosis factor-alpha (TNF)....