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2 August 2008 | By
Differential scanning calorimetry (DSC) is a widely used technique within the pharmaceutical industry because the range of phase transitions it can measure usually allows near complete physical characterisation of a new active principal early during preformulation. In addition, because DSC measures a property change that is ubiquitous† (heat) there are…
2 August 2008 | By
Advanced Aseptic Processing (AAP) is a term referenced in the recently published ISPE RABS definition1 to cover the spectrum of Restricted Access Barrier Systems (RABS) and isolator systems. In general, AAP techniques are physical barrier methods of product protection and containment that are used during manufacturing operations to separate (primarily)…
2 August 2008 | By
Dr. Janet Woodcock’s exhortation (ISPE Annual Meeting, 7 November 2005) that 21st century life science manufacturers should be ‘maximally efficient, agile and flexible’ and produce high quality drug products ‘without extensive regulatory oversight’ has been widely reported as a wake-up call to our industry.
2 August 2008 | By
As one of the world’s leading suppliers of products, solutions, and services to the Life Sciences sector, ABB is uniquely positioned to meet the current and future business and regulatory needs of the Life Sciences industry including Pharmaceuticals, Biopharma, and Biomedical...
19 July 2008 | By
MALDI FT-ICR MS platform for proteomics: Rationale for an offline approach and optimised implementation A number of sophisticated approaches have been developed to study the structure and function of genes, including the whole-scale sequencing of entire organisms[1], global transcriptional profiling[2], and forward genetic studies[3]. However, these techniques are ultimately limited…
19 June 2008 | By
Phenotypic drug discovery (PDD) has come of age – again. Using a microscope to observe a cell, one of the oldest techniques available to a cellular biologist dates back to the 17th century studies of Antony van Leeuwenhoek and his characterisation of ‘animalcules’. These early analyses, which simply described the…
19 June 2008 | By
European Pharmaceutical Review has brought together four individuals from different sides of the scientific palette to discuss current and future issues surrounding secondary screening and maximising its potential.
19 June 2008 | By
Drug discovery relies on massive screening of compound libraries with in vitro cell-based target assays. These pharmacological screens have been well accepted. For in vitro toxicological screening, this privilege has only been obtained for the Ames, chromosomal aberration and eye irritation tests. At the moment, a number of cellular assays…
19 June 2008 | By Dr Stefan Przyborski, Chief Scientific Officer, ReInnervate Ltd, School of Biological and Biomedical Science, Durham University
Cell culture assays play an important role during the first stages of pharmaceutical development. The design of such in vitro models is significant and data resulting from such tests directly influences the progression of compound development. Therefore it is becoming progressively more important to design cell culture assays that are…
19 June 2008 | By
Recombinant human interleukin-eleven (rhIL-11) is a pleiotropic cytokine which stimulates stem cell proliferation and affects multiple cell types1. The protein has been demonstrated to provide clinical benefit in platelet restoration2 and Crohn’s disease3. rhIL-11 is a highly basic protein that is rich in arginine, leucine and proline residues, lacks disulfide…
19 June 2008 | By
Siemens seeks to deliver breakthrough innovations to give customers a unique competitive edge, in turn enabling societies to master their most vital challenges and creating sustainable value. Siemens was one of the first suppliers to adopt the new guidelines of the Food & Drug Administration (FDA) and the European Agency…
19 June 2008 | By Serguei Tchessalov and Nicholas Warne, Wyeth BioPharma, Andover
During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals1-4. Recent advances in process control, such as the Smart Freeze-DryerTM technology or similar approaches, [5-7] make cycle development a routine procedure. The attention of many researchers has shifted…
19 June 2008 | By Graham Cook PhD, Senior Director, Process Knowledge/Quality by Design, Wyeth Pharmaceuticals
In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to…
19 June 2008 | By
PAT implementation gurus’ Expo Technologies talks to European Pharmaceutical Review about PAT and why they are at the top of their game.
19 June 2008 | By
MicroRNAs (miRNAs) are a class of small non-coding RNA molecules, which are potent post-transcriptional gene expression regulators. They have been shown to participate in the regulation of numerous cellular processes, the list of which is still growing. miRNAs affect numerous targets that can be determined by direct experiments or predicted…
