Analytical techniques

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From data to knowledge through smart Process Analytical Technologies (PAT) and process systems engineering

3 December 2008 | By

Pharma-Chem and bio-pharma development and production are now being profoundly influenced by the FDA PAT1 initiative with spectroscopic instrumentation being increasingly applied, or at the very least explored in product and process development and for on-line real-time process applications. The issues related to robust spectroscopic data analysis and calibration modelling…

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Addressing kinetic applications in High Content Screening

29 September 2008 | By

Traditional drug discovery screening assays tend to employ simplistic endpoint assays that often monitor the activity of a single target. While these approaches are amenable to high-throughput screening they provide limited information on how candidate drugs influence complex biological systems that exist in vivo. Such limitations are a contributing factor…

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Successful Process Analytical Technology (PAT) implementation in pharmaceutical manufacturing

29 September 2008 | By Thirunellai G. Venkateshwaran (Senior Director, New Products Quality, Global Quality and Compliance), John Levins (Senior Director, Technology Transfer & Process Innovation) and Stephen P. Simmons (Head of New Product Quality and Quality by Design), all Wyeth Pharmaceuticals

The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally…

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Live cell high content screening in drug development

2 August 2008 | By

Cell-based assays are essential for drug discovery and development as they increase the quality of lead compounds due to their physiological relevance. Toxicological data can be gathered during the early phases of hit selection and verification, reducing costs and attrition rates during clinical trials.

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Fast-scan differential scanning calorimetry

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…

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Quality by Design, Validation, and PAT: operational, statistical, and engineering perspectives

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.

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High content imaging subpopulation analysis for phenotypic drug discovery

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…

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Utilisation of secondary screening

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.

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In vitro toxicity screening as pre-selection tool

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…

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Siemens: innovation, industry and implementation

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…

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Wyeth’s PAT variations submitted through the EMEA Worksharing Procedure

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…

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Expo sets a new standard in PAT implementation

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.

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PAT – reducing the cost of quality in consumer products manufacturing

19 June 2008 | By

The ease in making process analytical measurements (typically spectroscopic) in manufacturing has provided a unique opportunity to obtain up-to-date information for making timely process correction decisions. At-line methods provide near-time information without the need for elaborate process control interfacing upfront. This approach works well for batch processing applications or unit…

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The state of industrial laboratory automation

7 April 2008 | By

Laboratory automation development is being increasingly outsourced to the commercial market according to a recent industrial member survey by the Association for Laboratory Automation (ALA). ALA polled 400 of its members in industry with 14 questions and received 72 responses representing 47 different companies in the Pharma, Biotech and Agriculture…

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Mass spectrometry based proteomics: trends in tools and strategies

7 April 2008 | By

Recent years have seen great upward leaps in the development of mass spectrometry applied to the field of proteomics. Today it is possible to take a complex biological sample such as organelles, cells, tissue or a biofluid, perturbed or stimulated in some way, and identify and quantitate up to several…