Cocrystals: defining the opportunity
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
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Articles
Issue #5 2014 – Digital edition
In this issue: Protein Characterisation, RMM, Flow Cytometry, Spray drying, NMR spectroscopy, Raman, Pharmaceutical salts, Sterile Control Strategies and much more...
RMM: In-Depth Focus 2014
Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable...
Raman Spectroscopy: In-Depth Focus 2014
Sulaf Assi discusses the investigation of medicine quality using handheld Raman spectroscopy, a look at Raman hyperspectral imaging, plus Raman roundtable...
Crystallography: A Core Science?
Crystallography is the science underpinning crystallisation, as well as a basic understanding of atomic arrangement within solids and their resulting structures. The United Nations announced that 2014 would be the International Year of Crystallography (IYCr2014). IYCr2014 commemorates the 100th anniversary of X-ray diffraction according to Bragg’s Law (celebrated by the…
A history of recombinant protein technology in small molecule drug discovery
28 October 2014 | By Rick Davies, Associate Director, AstraZeneca / Ian Hardern, Senior Research Scientist, AstraZeneca / Ross Overman, Associate Principal Scientist, AstraZeneca
Recombinant protein production is a prerequisite and essential component of most modern small molecule drug discovery programs. Target proteins are required to underpin screening, structural and mechanistic studies providing data that drives chemical design. From the initial establishment of recombinant protein production in the pharmaceutical industry in the 1980s, systems…
Flow cytometry for the optimisation of microbial recombinant protein production
28 October 2014 | By Tim W. Overton, Lecturer in Bioengineering, University of Birmingham
Flow cytometry is an extremely useful technique for the rapid analysis of many cell types. Here, the applications of this technique for the monitoring and optimisation of microbial recombinant protein production processes are discussed.
Spray drying in the pharmaceutical industry
Spray drying is one of the most remarkable technologies currently to be applied to pharmaceuticals. It is a continuous process that converts, in a single step, a liquid feed into a powder and is an ideal process when precise attributes such as particle size, morphology and stability are required. This…
NMR spectroscopy: a superior tool for quality control of pharmaceutical products
28 October 2014 | By Torgny Rundlöf, Pharmaceutical Evaluator, Medical Products Agency, Sweden
Pharmaceutical products have to be of high quality with respect to a number of predefined attributes, e.g. identity and strength with respect to the active pharmaceutical ingredient (API) and the presence and levels of impurities. At least for smaller compounds, such quality control often involves chromatographic methods. The examples given…
Pharmaceutical salts of small molecule drugs: opportunities and challenges
28 October 2014 | By Axel Becker, Scientist, Merck KGaA
Over the past decades, pharmaceutical drug development has undergone some significant changes, a prominent example for this being the emergence of biomolecular drugs (New Biological Entities, NBEs) such as antibodies and peptides. However, classical small molecule drugs (New Chemical Entities, NCEs) are far from being a dying species, and in…
Control strategies in the manufacturing of sterile pharmaceutical products
28 October 2014 | By James L. Drinkwater, F Ziel Head of Aseptic Processing Technology/GMP & Chairman of Pharmaceutical and Healthcare Sciences Society
Control strategies are often implemented when developing drugs and manufacturing biological and therapeutic products, however, increasingly they are considered important in the manufacture of sterile medicines. A control strategy for manufacturing sterile pharmaceutical products and substances sets out a documented approach and rationale taken to control product quality, efficacy and…
Issue #4 2014 – Digital edition
In Issue #4 2014: Protein Expression, Multivariate Data Analysis, Informatics in-depth focus, Particle Sizing, Lean Manufacturing, NIR In-depth focus, X-Ray Fluorescence and much more...
NIR: In-Depth Focus 2014
In this free-to-view NIR in-depth focus: Moving towards continuous manufacturing with NIRS and NIR-CI systems, Monitoring of pharmaceutical powder mixing by NIR spectroscopy...
Can HPLC assay methods really be considered quality critical tests?
Analytical method specificity is assessed using ICH (International Conference on Harmonisation) Q2 (2005). Although, certain methods are not specific enough for their intended purposes, they may have other advantages. Both titrimetric and UV (Ultra-violet spectroscopy) assays are non-specific, but have superior precision (ca. 0.1-0.5% RSD (Residual Standard Deviation)) compared with…
Informatics In-Depth Focus 2014
In this free-to-view Informatics in-depth focus: Reviewing the roles and opportunities for informatics in pharmacovigilance, Laboratory informatics: a wind of change?
