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Formulation

 

Eurofins BioPharma Product Testing Laboratories
Eurofins BioPharma Product Testing Laboratories
article

Eurofins BioPharma product testing laboratories

23 December 2014 | By Eurofins BioPharma

The largest network of harmonised bio/pharmaceutical gross manufacturing product (GMP) testing laboratories worldwide, Eurofins BioPharma Product Testing enables companies to advance candidates from development through to commercialisation while ensuring regulatory compliance, cost effectiveness and achievement of timelines...

drug discovery & drug development
drug discovery & drug development
article

Imaging for decision-making in drug discovery and early development

23 December 2014 | By Paul McCracken & Stephen Krause

The cost of drug discovery and development, depending upon the size of a given company, has been estimated upwards of $5 billion. Hay et al. recently published a review of clinical development success rates showing only a 10.4% likelihood of regulatory approval of all drugs entering Phase I, 64.5% of…

Recombinant protein
Recombinant protein
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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…

Pharmaceutical Salts
Pharmaceutical Salts
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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…

article

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…

article

Techniques to preserve product quality in pharmaceutical freeze drying

3 July 2014 | By , ,

In a pharmaceutical freeze drying process, it is mandatory to preserve product quality. This means that for a given formulation that has to be freeze dried, the temperature has to remain below a limit value corresponding to the eutectic temperature for a product that crystallises after freezing, with the goal…

article

NMR – Recent developments for isotope profiling

3 July 2014 | By

Fraudulent misrepresentation, substitution or imitation of premium products has always been a problem for both the regulatory authorities and the pharmaceutical industry. The task of finding and preventing counterfeit products is particularly challenging1,2. Several analytical techniques are available to help characterise pharmaceutical compounds: physical profile; X-ray diffraction; infrared spectroscopy; mass…

Thus the combination of complex physical properties of powders and numerous environmental variations, such as humidity, illustrate why powder processing is so challenging.
Thus the combination of complex physical properties of powders and numerous environmental variations, such as humidity, illustrate why powder processing is so challenging.
article

Pharmaceutical powders characterisation – the need for a multivariate approach

3 July 2014 | By Brian Armstrong and Katrina Brockbank, Freeman Technology

Powders and bulk materials are widely used in industry as raw materials, intermediates and finished products. Indeed, over 60% of the value of pharmaceutical sales worldwide is accounted for by powder formulations, typically as tablet/capsule/sachet or in the form of an inhalable powder. Whilst they are used extensively, they are…

Dennis Douroumis
Dennis Douroumis
article

Hot melt extrusion processing for the development of sustained release products

15 April 2014 | By Dennis Douroumis, Reader in Pharmaceutical Sciences at the University of Greenwich and the Director of Centre for Innovation in Process Engineering and Research

Hot Melt Extrusion (HME) has attracted increased interest for the development of pharmaceutical dosage forms over the last decade. It is a versatile processing technology which produces extrudates in the form of solid dispersions and solid solutions. Among the various applications, HME has been adopted for the development of sustained…