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Articles

NMR Spectroscopy
NMR Spectroscopy

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
Pharmaceutical Salts

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…

gene therapy
gene therapy

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…

David Elder
David Elder

Can HPLC assay methods really be considered quality critical tests?

5 September 2014 | By

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…

Protein Expression
Protein Expression

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…

Particle Resizing
Particle Resizing

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 Thinking
Lean Thinking

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…