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3 July 2015 | By Julien Villaumié and Hilary Jeffreys, Actavis
All regulatory agencies require that manufacturers accurately determine the amount of drug in a medicinal product so that the product can be deemed fit for patients. This forms part of batch release testing performed by Quality Control (QC) laboratories. The drug assay and/or content uniformity of the dosage units is…
3 July 2015 | By David P. Elder, Phil Borman and George Okafo - GlaxoSmithKline
The most commonly used analytical technique for the testing of drug molecules is reversed-phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV)/visible detection. However, one of the biggest constraints affecting UV/visible detectors is their inability to generate adequate sensitivity for analytes lacking a suitable UV chromophore.
In an interview with European Pharmaceutical Review, Gilles Goy, Operational Manager of the European Endotoxin and Microbial Detection Contract Staff Laboratory, Charles River, discusses the company’s Accugenix® AccuPRO-ID® service...
3 July 2015 | By Patrick Giraudeau, University of Nantes
Nuclear magnetic resonance (NMR) spectrometry is a major quantitative tool in pharmaceutical analysis, owing to its extremely high accuracy. However, absolute quantification in complex mixtures is often hampered by spectral overlap which considerably reduces the quantitative performance of NMR.
3 July 2015 | By Payal Roychoudhury, PhD, formerly AstraZeneca
The past decade has been a period of unparalleled change and development in the fermentation industry. As the nature of this industry evolves, and in particular, with the increasing prominence of the new biopharmaceuticals (therapeutic proteins, diagnostic enzymes and monoclonal antibodies) the need for effective bioprocess monitoring grows in importance1.
In Issue #2 2015: Outsourcing, Drug pricing reforms, Stem Cells in-depth focus, Microbiology series, Environmental monitoring, LC-MS in-depth focus, Manufacturing solutions, PAT series and much more...
In this free-to-view Stem Cells In-Depth Focus, you can find out how computational ('in silico') methods can help to rationally choose bioactive small molecules to improve stem cell differentiation. The differentiation of pluripotent stem cells to hepatocyte-like cells is the focus of a second interesting article...
In this free-to-view LC-MS in-depth focus, we delve into the world of glycans, and how their natural complexity necessitates sophisticated sequencing techniques, while another article aims to demonstrate the versatility of LC-MS and the ease with which it can be combined with a variety of MS systems, focusing particularly on…
20 April 2015 | By Dave Elder, GlaxoSmithKline and JPAG
Increasing research and development costs, low productivity, reduced product life cycles, governmental pricing containment, convergence of technologies and increasing regulatory oversight are challenges that increasingly provoke pharmaceutical companies into making precompetitive collaborations with other organisations.
20 April 2015 | By Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited
Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the…
20 April 2015 | By Ulrich Kaiser, University of Zurich / Susan Mendez, Melbourne Institute of Applied Economic and Social Research / Thomas Rønde, Copenhagen Business School / Hannes Ullrich, DIW Berlin and University of Zurich
Reference price systems for prescription drugs have found widespread use as cost containment tools. Under such regulatory regimes, patients co-pay a fraction of the difference between pharmacy retail price of the drug and a reference price. Reference prices are either externally (based on drug prices in other countries) or internally…
20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant
Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…
20 April 2015 | By Ivo Backx, Manager, Business & Project Development for the Pharmaceutical Industry, Siemens
Ivo Backx of Siemens discusses continuous processing in the context of the company’s Simatic PCS 7 system and PAT software...
20 April 2015 | By Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University
Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material…
