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Breaking old habits: Moving away from commonly used buffers in pharmaceuticals

10 July 2012 | By David Sek, Research Scientist, Pfizer

One of the key factors in stabilising proteins is determining the optimal pH and buffer system to provide adequate solubility and stability. Currently, three buffers, citrate, phosphate and acetate, make up the majority of buffers used in parenteral pharmaceuticals approved by the FDA, but less precedented excipients are certainly available…

Applications of thermally stimulated current spectroscopy in pharmaceutical research

10 July 2012 | By Milan Antonijević, School of Science, University of Greenwich

Thermally Stimulated Current Spectroscopy (TSC) is a new tool that can be used to analyse pharmaceutically important molecules. TSC studies are usually conducted to provide additional information about molecular mobility in the solid state, and as a result characterise phase transitions that are related to thermal transitions in the crystalline…

Discovery and validation of protein biomarkers

10 July 2012 | By Péter Horvatovich & Rainer Bischoff, Analytical Biochemistry, Department of Pharmacy, University of Groningen

Biomarkers are biological characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention. Biomarkers can be used to determine disease onset, progression, efficacy of drug treatment, patient susceptibility to develop a certain type of disease or predict efficacy…

Ten years of siRNA – a clinical overview

10 July 2012 | By Katharina Bruno, Principal Scientist, Technical Research & Development (TRD), Novartis Pharma AG

In 2001, small interfering RNA (siRNA) was discovered as the mediator of RNA interference (RNAi), a transient and specific repression mechanism of protein expression1. After the pharmaceutical industry became aware of the intrinsic versatility and potential of this molecule, a race to develop the first siRNA based drug began. However,…

Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations

10 July 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for…

The need for proteomic-based biomarkers in the drug development pipeline

10 July 2012 | By Paul C. Guest, Department of Chemical Engineering and Biotechnology, University of Cambridge and Sabine Bahn Department of Chemical Engineering and Biotechnology, University of Cambridge & Department of Neuroscience, Erasmus Medical Centre

Pharmaceutical companies are under increasing pressure to improve their efficiency and returns on drug discovery projects. This is a daunting task considering that the average drug costs approximately one billion US dollars to develop and takes around 12 years from initial discovery to reach the market1. In addition, approximately 70…

Process Analytical Technology (PAT) In-Depth Focus 2012

6 July 2012 | By

In this PAT In-Depth Focus: Process analytics experiences in biopharmaceutical manufacturing; Correlation between powder rheology data and processability in solid dosage form manufacturing; Expert industry users of process analytical technologies for pharmaceuticals pose questions for leading vendor experts of process analytical technology...

At the crossroads: The next decade

26 April 2012 | By J. Paul Robinson, Purdue University Cytometry Laboratories & Weldon School of Biomedical Engineering, Purdue University; Bernd Bodenmiller, Group leader, Institute of Molecular Life Sciences, University of Zurich; Valery Patsekin and Bartek Rajwa, Purdue University Cytometry Laboratories, Purdue University; and V. J. Davisson, Medicinal Chemistry & Molecular Pharmacology, Purdue University

Flow cytometry is the technology that has the most impact on single-cell analysis. Over the past 40 years, it has arguably been the single most important research technique in the fields of basic and applied immunology. Flow cytometry excels in quantitative evaluation of receptor expression, separation of functionally defined cell…

Implementing chemometrics in late stage development and manufacturing

26 April 2012 | By Geir Rune Flåten, former Chemometrician Leader in Global Manufacturing and Supply at GlaxoSmithKline

Chemometrics was defined as a research area in 1974 and developed rapidly through the following decades in parallel with the fast paced improvement in analytical technologies and computational power for lab instruments and sensors. Chemometrics is essentially the translation of measured signals characterising a sample or a process into meaningful…

Building robust PCR/qPCR assays

26 April 2012 | By Linda Starr-Spires, Director, Nucleic Acid Methods Platform, Global Clinical Immunology Department, Sanofi Pasteur

The process of building robust PCR/qPCR assays is a matter of perseverance and consistency. A few questions that should be answered prior to starting development will help make the process more efficient and effective: Does the assay need to simply detect the presence of the target (qualitative), or must it…

Applications of Raman, CARS and SRS imaging in dosage form development

26 April 2012 | By Clare Strachan, Senior Lecturer Pharmaceutical Sciences, School of Pharmacy, University of Otago

The use of Raman spectroscopy in pharmaceuticals has grown enormously since its appearance on the scene in the 1980s1-4. While typical Raman spectroscopy setups are able to provide chemical and physicochemical information about the sample on the bulk level, most solid samples in the pharmaceutical setting may not be assumed…

Discovery chemistry outsourcing

26 April 2012 | By Luigi La Vecchia, Director of the Preparations Laboratories, Novartis Institute for Biomedical Research

In 2002, Novartis decided to create a new research centre in Cambridge, MA. This was accompanied by a significant increase in headcount in medicinal chemistry. Within two years, this resulted in a strongly increased demand for prep-scale synthesis which in turn led to priority issues and to prolonged turnaround times…

Outsourcing in early drug discovery: Evolution and opportunities

26 April 2012 | By Jayshree Mistry, Paul Lloyd, Kevin Oliver and Peter North, GlaxoSmithKline R&D and Duncan Judd, Awridian

This article describes the evolution of outsourcing within early drug discovery at GlaxoSmithKline (GSK), specifically for chemistry services applied to developing a compound from the screening hit through lead optimisation. It will touch on different business models, factors to consider when selecting potential CROs, the benefits of outsourcing and CRO…