30 November 2002
Chiralabs collaborates with the Centre for Biospectroscopy at Imperial
College
Chiralabs has agreed to collaborate with the Centre for Biospectroscopy at the Imperial College
of Science, Technology and Medicine (London University) on studies into the properties of drugs in solution and in
the solid-phase.
2 September 2002
Inaugural BEACON conference
The first Biopharmaceutical
Effective Analysis Conference was held at Warwick University on the 2nd September 2002. On this occasion the topic
was "Determining Critical Quality Parameters for Biopharmaceuticals". Speakers discussed a range of issues from
regulatory, commercial and scientific view-points. The meeting was very well attended, with participants spanning
industry, governmental institutions and academia, allowing wide-ranging discussions.
16 May 2002
Chiralabs helps validate biopharmaceutical analysis
Chiralabs
is collaborating with the UK national standards laboratories and the pharmaceutical industry to assess and validate
the spectroscopic analysis of biopharmaceuticals. A preliminary study with the National Physical Laboratory,
the National Institute of Biological Standards and Control, GlaxoSmithKline and Imperial College has been
undertaken to provide comparative cross-site evaluation of optical and chiroptical spectroscopies.
The preliminary study highlighted consistency issues in the use of circular dichroism, uv-visible absorption and fluorescence spectroscopies when characterising antibody biopharmaceuticals. A more extensive study of the use, interpretation and validation of circular dichroism is now proposed.
May 2002
Chiralabs in DTI funded Measurements for Biotechnology
study
Chiralabs joins forces with the National Physical Laboratory (NPL), the National Institute
of Biological Standards and Control (NIBSC), GlaxoSmithKline, the Imperial College of Science, Technology
& Medicine, Jasco(UK) and Ludger in a Measurements for Biotechnology project funded by the UK government (DTI).
The project will investigate the most appropriate spectroscopic and physicochemical techniques for characterising the higher-order structure of glycoproteins in order to achieve "well-characterised" status as biopharmaceuticals. The relationships between biological function, product integrity and higher-order structural changes will be probed to ensure deleterious versus benign changes can be distinguished.
April 2002
Chiralabs joins BEACON
Chiralabs joins the Biopharmaceutical
Effective Analysis CONsortium.
BEACON is a group which aims to develop and promote the effective use of
validated techniques for the understanding, analysis and quality control of biopharmaceuticals. Its members
include major pharmaceutical companies, government research & national standards laboratories and leading
university laboratories.
A key goal is to establish reliable suites of in vitro methods for characterising biopharmaceuticals that are able to distinguish benign from deleterious changes in products, both in terms of product chemical integrity (stability, form etc.) and biological function (efficacy, activity, availability etc.). A particular effort is being made in understanding the role of higher-order structure in glycoprotein therapeutics, such as immunoglobulins.