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Articles

Why is thermal analysis important to the industry?

11 November 2005 | By Dr Paul G. Royall, Lecturer in Pharmaceutics, School of Chemical Sciences & Pharmacy University of East Anglia, See-wah Jai Tang, Pharmaceutical Science Research Division, King’s College London

Thermal analysis equipment can be found in nearly all of the analytical, development, formulation and QA laboratories within the pharmaceutical industry. However, these work horse instruments are learning to run faster and to analyse an ever more varied field of samples.

wiggenhorn figure 2
wiggenhorn figure 2

The current state of PAT in freeze drying

11 November 2005 | By Michael Wiggenhorn, Gerhard Winter, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University and Ingo Presser, Boehringer Ingelheim

Freeze drying is a widely used method to stabilise protein pharmaceuticals. The stability of proteins and the biological activity can be influenced by several factors, which may lead to conformational changes and to denaturation, aggregation or absorption to surfaces1.

Microbial detection in mammalian cell culture systems

11 November 2005 | By Amy McDaniel, Ph.D., QC Manager, Microbial Science & Technology, Wyeth Biotech

Timely results for microbial bioburden monitoring of in-process cell culture samples are critical to the production process for recombinant proteins and other biopharmaceutical products.

The promise and pitfalls

22 August 2005 | By Craig S. Mickanin, Research Investigator and Mark A. Labow, Executive Director, Genomic and Proteomic Sciences, Novartis Institutes for BioMedical Research

Perhaps the most significant technological advancement in the study of gene function in the post-genome era has been the discovery that RNA interference (RNAi) can be exploited for depletion of endogenous mRNA in mammalian cells. As the pharmaceutical industry has fallen under intense pressure to both identify and validate high-quality…

Biomarkers of efficacy and safety

22 August 2005 | By Dr Graham R Betton, Senior Principal Scientist, Safety Assessment, AstraZeneca Pharmaceuticals

This article reviews the types of biomarkers currently available and approaches to discovering new biomarkers.

Plasma protein biomarker discovery

22 August 2005 | By Gilbert S. Omenn, M.D.,Ph.D University of Michigan

Less than a week after Nature and Science published the special issues on the ’blueprint‘ for the human genome sequence 15-16 Feb, 2001, the Financial Times of 21 February, 2001, ran a major article about proteomics, calling proteins “the real stuff of life”. Proteins are, indeed, the effector molecules for…

Initiatives from Spain

22 August 2005 | By José M Mato, Isabel Pérez-Mato, Félix Elortza, CIC bioGUNE and Julio Font, Noray Bioinformatics, S.L

The availability of the complete sequence of some model organism genomes, including the human genome, offers new opportunities for biological research. The goal is to establish technology to identify all the proteins involved in a particular biological process and the interactions between them.

Analysing the monographs

22 August 2005 | By Erwin Adams, Ann Van Schepdael and Jos Hoogmartens, Laboratory for Pharmaceutical Chemistry and Drug Analysis, Catholic University of Leuven, Belgium

The European Pharmacopoeia (Ph. Eur.)1 monographs are subject to regular adaptation in order to cope with progressing quality requirements. This contribution outlines the evolution in analytical requirements and techniques in monographs for organic substances. These monographs generally carry the subheadings definition, characters, identification, tests, assay and impurities.

The AstraZeneca ACMF

22 August 2005 | By Dr Dalin Nie, Associate Director, and Deborah S. Hartman, Director, Lead Discovery, AstraZeneca Pharmaceuticals, Wilmington

Compound management is an emerging discipline that represents a core component of the drug discovery process, from early phases involving high throughput screening (HTS) to late-stage lead optimisation screening cascades.

Taking care of innovation

22 August 2005 | By Thomas Keller, MPhil, PhD, Head of Applied Technology Group UK, European & International Operations, GlaxoSmithKline R&D

The most important factors for ensuring a successful future are innovation and an effective governance structure. Within this model1 in the pharmaceutical industry, the introduction of new technology is one of the key factors. This provides an organisation with efficient and reliable systems to facilitate the incorporation of new scientific…

Support for lead optimisation and target validation

22 August 2005 | By Stefan Prechtl, Group Leader, High Content Analysis and Philip Denner, Schering AG

High-Content Analysis (HCA) provides a drug discovery tool capable of rapid screening of drug effects in pharmacologically relevant cell culture systems. Interest in HCA has been increasing during the past few years. This reflects the confidence that HCA-technology has established due to the stability and reliability offered to the drug…

The road ahead and how to get there

22 August 2005 | By James Herrington and Owen B. McManus, Department of Ion Channels, Laszlo Kiss, Pain Research, Merck Research Laboratories

Ion channels are membrane spanning proteins with narrow hydrophilic pores that support the passive flux of inorganic ions across the cell membrane.

The rise of Raman

22 August 2005 | By Marleen de Veij, Dr. Peter Vandenabeele and Prof. Dr. Luc Moens, Laboratory of Analytical Chemistry, Ghent University

Traditionally, analyses in pharmaceutical research and industry were often performed using Nuclear Magnetic Resonance (NMR) or Mass Spectrometry (MS). However, researchers are aware that Raman Spectroscopy possesses advantageous characteristics for the pharmaceutical world.

A Pfizer perspective

22 August 2005 | By Joep Timmermans, Ph.D., Senior Manager/Team Leader, Process Analytical Support Group – Americas Implementation Team, Pfizer Global Manufacturing

While the current attention and focus on Process Analytical Technologies (PAT) may make you believe otherwise, PAT measurement systems have been used in the pharmaceutical industry, Pfizer included, for some time, albeit often to a limited extent.

International standards: a tool for compliance

22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting

Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.