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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
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.
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…
Are the needs of the pharmaceutical industry being met?
25 January 2007 | By Dr Andrew M. Middleton, GlaxoSmithKline
Subsequent to the publication of the PDA technical Report Number 33 in 20001 there has been a multitude of articles published in pharmaceutical reviews and commentaries with regard to rapid microbial methods (RMM). The majority of these articles cover, to a greater or lesser degree, the technologies available and summaries…
Challenges in High-Content siRNA Screening
28 November 2006 | By Dr. Eberhard Krausz, HT-Technology Development Studio (TDS), Max Planck Institute of Molecular Cell Biology and Genetics (MPI-CBG)
Huge progress has been made, both in RNA interference technology applied to mammalian cells and in automated microscopy to analyse gene functions upon silencing in the cellular context. Large-scale siRNA screens have been published recently, mainly applying assays that gain multi-parametric information on biological processes. It is a long way…
HUPO drives the creation of protein test standards
28 November 2006 | By John R. Yates, III, Department of Cell Biology, The Scripps Research Institute, Thierry Rabilloud, DBMS/BMCC, Alexander W. Bell, Montreal Proteomics Centre, McGill University and John J. M. Bergeron, Department of Anatomy and Cell Biology, McGill University, Quebec
Over the last ten years the Proteomics field has been a technologically dynamic area. New methods and techniques help drive the field to achieve more sophisticated measurements that yield increasingly larger volumes of data and information. This creates several problems.
Industry Insight: The measure of success
28 November 2006 | By EPR
“Getting to results faster and with higher data quality are challenges for major techniques, especially separation techniques such as LC and LC/MS.” explains Jaquemar. “Equally, solutions for secure information management are rapidly gaining in importance.”
