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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…
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…
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 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…
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…
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…
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…
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...
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...
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…
In this free-to-view Informatics in-depth focus: Reviewing the roles and opportunities for informatics in pharmacovigilance, Laboratory informatics: a wind of change?
5 September 2014 | By Marco Casteleijn & Dominique Richardson, University of Helsinki
Pharmaceutical biotechnology is big business; it currently consists of 1/6 of the total volume of the pharmaceutical market and continues to grow steadily. Expression of therapeutic proteins is mainly done in living cells, although ‘cell free protein synthesis’ (CFPS) or ‘in-vitro transcription translation’ (IVTT) is beginning to emerge as an…
5 September 2014 | By Dr. John H. Kalivas, Editor for the Journal of Chemometrics and Applied Spectroscopy.
In the pharmaceutical industry, it is necessary to control, in a tight range, the active pharmaceutical ingredient (API) content of products, e.g., tablets or other powder blends.
5 September 2014 | By Driton Vllasaliu and Ishwar Singh, University of Lincoln
The use of materials in nano-scale dimensions is proving to be a promising approach to overcome drug delivery challenges. ‘Nanomedicine’ technologies are gradually achieving commercial success and reaching the clinic. Sub-micron nanocarriers have the potential to ferry the therapeutic to its site of action and in this process overcome the…
5 September 2014 | By Dr. Stephen McGrath, Teva Pharmaceuticals Ireland (TPI)
Organisations are constantly striving to drive down costs while maintaining the quality of their products and services. In recent years, much has been written in both the academic and practitioner literature on the application of Lean principles for the elimination of waste and focusing of energies on value-creating activities.
