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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
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?
Engineering cells and proteins – creating pharmaceuticals
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…
The flexibility of regularisation processes for multivariate calibration maintenance
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.
Particle characterisation in drug delivery
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…
Lean, Six Sigma, people and organisations
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.
Novel methodologies for determining the mineral content of complex multivitamin tablets
5 September 2014 | By Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada
Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process…
