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Articles

Calorimetry for polymorph detection

27 March 2007 | By Simon Gaisford PhD., School of Pharmacy, University of London and Michael AA O’Neill PhD., Department of Pharmacy and Pharmacology, University of Bath

Characterising the properties of a material, understanding how these properties change in relation to local environment and quantifying potential interactions with other species are facets central to any drug development programme. Not understanding and, more importantly, not controlling these factors can have serious consequences for a pharmaceutical, from irreproducible processing…

PAT and scalable automation for bioprocess control and monitoring

27 March 2007 | By Joydeep Ganguly, PAT Group Lead and Gerrit Vogel, Senior Engineering Manager, Talecris Biotherapeutics

This case study provides a comprehensive look at Talecris1 Biotherapeutics’ approach to PAT and automation followed by examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts and explains how the selected automation effectively supports initiatives such as…

Advancing the science of drug discovery

27 March 2007 | By EPR

Montréal, one of Canada’s most vibrant and beautiful cities, provides an idyllic setting for the Society of Biomolecular Sciences’ 13th Annual Conference & Exhibition. The 2007 scientific program encompasses many of the core themes from previous SBS conferences, including target biology and screening strategies, as well as new instrumentation and…

Cleanroom standards

27 March 2007 | By John Neiger, Technical writer and consultant

It is some years since the ISO 14644 and 14698 series of international cleanroom standards started taking over from national standards. Early parts are already undergoing their statutory five-year reviews; other parts have only recently been published and new parts are still being written.

Taking clinical trials into the future

27 March 2007 | By EPR

Q1: Please outline the general process of Phase I clinical trials. Burnand: Phase I is the screening for safety process and it’s the first time that a product is given to a human being. The aim at this stage is to demonstrate that the product isn’t dangerous. The data will…

A new challenge in the pharmaceutical supply chain

27 March 2007 | By Montanari R. and Rizzi A., Dipartimento di Ingegneria Industriale, Università degli Studi di Parma

Current trends show that the Radiofrequency Identification (RFID) technology and Electronic Product Code (EPC) are experiencing increasing diffusion. Several business applications adopting RFID are currently expected to grow strongly. Bar codes and RFID will coexist for many years, although the former is likely to progressively replace the latter in some…

Cancer immunotherapy using RNAi

25 January 2007 | By Chih-Ping Mao, Department of Pathology, Chien-Fu Hung, Ph.D, Department of Pathology and Oncology and T-C Wu, Ph.D., Department of Pathology, Oncology, Obstetrics and Gynecology and Molecular Microbiology and Immunology, Johns Hopkins Medical Institutions

Immunotherapy has recently emerged as an attractive form of treatment for cancer due to the potential of the immune system to eradicate tumours without inflicting damage on normal tissue. However, natural immune responses are usually inadequate to control cancer progression and require enhancement by vaccines.

A new field in biomarker discovery and target identification

25 January 2007 | By Dr. Ina K. Dahlsveen, Exiqon

The last few years have seen a rush of discoveries within a new field of post-transcriptional gene regulation. microRNAs, or miRNAs for short, are small regulating RNAs akin to small interfering RNAs (siRNA), but which are naturally expressed in vivo. Originally discovered in C. elegans 14 years ago, these small…

The role of phospho-proteomics in drug discovery and development

25 January 2007 | By Ze’ev Gechtman, Ph.D., formerly of Johnson & Johnson

While scientific discoveries can be turned into financial assets, the scientific process itself has proven difficult to harness to efficiently create marketed products bringing profits. This translation is especially challenging for the pharmaceutical and biotechnology industries owing to the tremendous complexity of biological systems.

High throughput electrophysiology platforms as enablers

25 January 2007 | By Peter Haddock, PhD., Pfizer Global Research and Development, CNS Pharmacology

Ion channels play key roles in regulating cardiac, neuronal and secretory tissue function. As such, the pharmacological modulation of ion channel activities may provide an effective means to positively impact upon an array of disease states. However, the reliance on low-capacity manually operated electrophysiology screening systems has dictated that ion…

New opportunities for protein crystallisation

25 January 2007 | By EPR

In a previous article the important role of protein crystallography in the optimisation of drug candidates was highlighted1. An essential part of this process is establishing robust protein crystallisation systems that can be used for both soaking and co-crystallisation experiments. This may mean producing many hundreds of X-ray quality crystals…

Real-time PCR gene expression profiling

25 January 2007 | By Mikael Kubista, TATAA Biocenter and MultiD Analyses AB, Sweden, Björn Sjögreen, Center for Applied Scientific Computing, Lawrence Livermore National Laboratory, United States and MultiD Analyses AB, Amin Forootan, MultiD Analyses AB, Radek Sindelka and Jiri Jonák, Laboratory of Gene Expression, Institute of Molecular Genetics, Academy of Sciences of the Czech Republic and José Manuel Andrade, Dept of Analytical Chemistry, University of A Coruna, Spain

Real-time PCR has rapidly become the preferred technique for quantitative analysis of nucleic acids. Its superior sensitivity, reproducibility and dynamic range make it the preferred choice for expression profiling in scientific, as well as routine, applications.

Dr Henning Gieseler
Dr Henning Gieseler

PAT for freeze drying: cycle optimisation in the laboratory

25 January 2007 | By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg

Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying…

PAT for the product lifecycle of a biopharmaceutical product

25 January 2007 | By Ronan O’Kennedy, Biopharmaceutical Process Development, Biopharmaceutical CEDD, GlaxoSmithKline

The biopharmaceuticals industry has undergone a number of revolutions in the past decade, not least the variety of ‘omics’ that focus on high throughput technologies to identify new product targets and can rapidly characterise those targets at small scale. However, it has been widely recognised that the technology used in…