Intertek ASG Laboratory, Manchester, UK

Intertek ASG News Archive 2007

Intertek ASG News Releases from 2007
  

To view recent news items, visit the current news page.

Meet Intertek ASG Representatives at Pharmaceutical and Biotech Exhibition and Conferences

(March 2007)

Intertek ASG will be promoting their extensive range of pharmaceutical and biopharmaceutical characterization, analysis and problem solving services during a diary of national and international exhibitions and conferences this coming year. ASG representatives shall be attending and exhibiting at a number of UK events and also international events such as the American Analytical Pharmaceutical Scientists (AAPS) 2007 National Biotechnology Conference in San Diego, followed by the International Contract Services Expo (ICSE), Milan. Intertek Pharmaceutical and Specialty Chemicals Division will also be represented at In Cosmetics, Paris, 17 - 19 Apri 2007, Land O'Lakes Bio-Analytical Conference, Wisconsin, 9 - 13 July 2007 and AAPS Annual Meeting, San Diego, November. If you would like to know more about these events or would like to arrange a one-to-one meeting during these events then please email ASGlab@intertek.com.

For more information and dates, see:

• Intertek ASG Conferences, Events and Training

Advanced Services for Polymers in Pharmaceutical Formulations

(March 2007)

Intertek ASG offers extensive competencies for analysis of synthetic polymers used in pharmaceutical products. Polymers are used in a range of pharmaceutical applications including inactive matrices and surface coatings on capsules and tablets. Intertek ASG laboratory offers a wide range of characterization capabilities which allow detailed characterization of monomers, oligomers and polymer materials, products and processes. ASG supports process optimization, scale up and regulatory submissions for notification of new substances (NONS) and the development and manufacture of pharmaceuticals, biopharmaceuticals and polymeric pharmaceutical ingredients. Applications studied in the laboratory have included development of new surface coatings and colourant formulations and reactive oligomers for modification of pharmaceutical small molecule API’s and for grafting on to biological molecules.

For more info see:

• Pharmaceutical Polymer Analysis

Intertek ASG Supports North West Biotechnology Partnering Launch

(February 2007)

Intertek ASG supported the launch of a free chemistry partnering service for North west Biotechnology cluster recently. This initiative launched by the University of Manchester is aimed providing eligible SMEs with access to a wide range of commercial and academic expertise. The Service, which is a joint venture with the University of Manchester Incubator Company (UMIC) was launched at UMIC’s Core Technology Facility in Manchester.

For further information please visit:

• www.chemistrypartnering.com

Development of Fluorescence Methods for Protein Stability

(February 2007)

Intertek ASG have recently completed an in-house research project on the application of fluorescence spectroscopy in the characterisation and study of protein secondary structure in a formulated protein product. Fluorescence is an ideal probe for protein secondary structure as it can detect fluorescent amino acid residues in the backbone (e.g. tryptophan and tyrosine) with relatively little interference from the environment. The wavelength of fluorescence emission is sensitive to the environment of the amino acid residue and so can be used to probe the protein structure.

EU FP6 project Hy3M Update: Dynamic Properties of Interlocked Polyrotaxanes

(January 2007)

Advances have been made by Intertek ASG in the EC FP6 project Hy3M. Research techniques to study the dynamics of exchange processes in association complexes have been applied to interlocked polyrotaxane compounds supplied by network partners. Additionally, a method is being developed for FTIR characterisation of structural features in complex molecules, potentially suitable as a QC check method for functional molecules in devices. Proteins are employed to act as supramolecular model compounds to allow study of the conformational structure by deconvolution and analysis of the amide I band in the FTIR spectrum. It is anticipated that this will extend our capabilities to characterise the conformational structure of complex molecules and arrangements of molecules.

Funded by EC Framework 6 NMP priority – CT-2004-013525

Fibre Contamination Troubleshooting for Pharmaceutical Formulations

(January 2007)

Fibre contamination in packaged products can be a worrying problem for manufacturers. Intertek ASG has carried out numerous investigations over the past year involving particle contamination identification in pharma liquid products. Intertek scientists have developed techniques for the isolation of minute particles, often plastic, rubber or textile fibres of sizes down to a few microns. Identification can be achieved via spectroscopy and microscopy methods with IR microscopy being a key technique in these studies. Comparison to a range of likely sources of these particles helps to confirm ID.

New Preparative Scale Chromatography Service

(January 2007)

In October Intertek ASG launched an expanded set of state-of-the-art analytical characterisation services for macromolecule medicines. Located at the GLP / cGMP facility in Manchester, UK, these services focus on the isolation and characterisation of product related impurities at the analytical or preparative scale. These unique services were launched at ICSE 2006 and have since featured in OutSourcing-Pharma.com News. This £100,0000 investment includes FPLC, HPLC or SEC at the preparative and analytical scale and also PAGE / SDS-PAGE techniques at the analytical scale and are highly relevant to clients involved in characterisation of complex products and for use in the validation of product release assays.

Intertek ASG has extensive expertise in the physicochemical characterisation and analysis of biopharmaceuticals and other macromolecule medicines. Related services include: structural characterisation including characterisation of isolated impurities, higher order structural characterisation, aggregation state characterisation, process impurity method development, validation and QC.

Successful Inspection for Intertek ASG by MHRA

(December 2006)

Intertek ASG had a successful scheduled audit by the MHRA in September 2006 to GLP and cGMP standards. The audit outcome was very positive with the auditors citing several examples of best practice evident during the audit. The laboratory has a long history of providing regulatory analytical support and has held a Statement of GLP Compliance since 1987. If you would like to find out more about our Quality Assurance systems then please visit our web page.

For more information see:

• Intertek ASG Quality Assurance