Toxikon Outlines New Extractables / Leachables R&D Activities for the Next Five Years

27th September 2011

Toxikon Europe, a preclinical contract research organisation specialised in extractables and leachables testing for the pharmaceutical and biopharmaceutical industries, is ramping up its research and development by investing approximately $500,000 annually over the next five years to further increase its extractables and leachables expertise and capabilities to meet the ever-evolving development needs of its life science clientele.

This initiative will confirm the leading position of Toxikon Europe in E&L testing through an unmatched level of service and scientific quality of the analytical data, provided in their reports.

"I am very enthusiastic about these new developments," says Dr. Laxman Desai, CEO and founder of Toxikon Corporation, Toxikon Europe’s parent company. "It is clear that, with the dedication the European and US staff has shown to provide premier E&L services for the pharmaceutical industry, Toxikon has become a world-class research organisation in this field. However, by listening to our customers, we understood that there is a large need to further unravel the science of extractables and leachables, both from an analytical and a toxicological point of view, as the safety assessment of containers and closures is becoming one of the main issues in drug development."

Toxikon Europe began bolstering its R&D activities about four years ago with the development of the TOX-RAY™ screener database. The database allows a unique compound identification based upon a double identity confirmation (retention time and mass spectrum) in ‘first pass’ testing in controlled extraction studies. Today, the database contains over 2,000 analytical standards of compounds relevant to pharmaceutical materials testing.

"The TOX-RAY database is now considered an industry standard," Dr. Desai says. "Since the initial launch in September 2010, the TOX-RAY database has received a lot of attention from the pharma industry, especially of the large pharma companies who are performing their own extractables and leachables research."

As the TOX-RAY database is a large step forward in the identification of extractables and leachables, the structures of a substantial amount of polymer impurities remain unknown. Toxikon is investing heavily in Toxikon Europe’s analytical equipment to elucidate the structure of these compounds, such as GC-ToF and UPLC-AMS (AMS: accurate mass spectrometry). In a concerted effort, unknown polymer impurities will be studied with GC-ToF and LC-AMS and the results of these investigations will help to further build the TOX-RAY Database to an unparalleled level.

For many polymer impurities, however, no commercial standards are available. For these compounds, it is often a challenge to obtain analytical standards in order to perform qualification and quantification studies in the medicinal product. Through the TOXYNTH™ Synthesis Services, Toxikon can offer an unmatched level of identification and quantification for a wide range of extractables and leachables, of which commercial standards are not available. The TOXYNTH Synthesis Services will also be used to further develop the TOX-RAY extractables screener database, used in the identification of extractables in ‘first pass’ experiments.

"It is our intention to obtain a full identification of most of the common polymer impurities in a five-year time frame," Dr. Desai says. "By further developing the TOX-RAY database, in combination with high-end analytical research and the TOXYNTH Synthesis Services, all our customers will reap the benefits from our analytical R&D efforts. The scientific level of the analytical data will be unequalled."

Extractables and leachables research is not only facing analytical challenges. For a lot of extractable and leachable compounds – especially for compounds which are not commercially available – no toxicological data are available. In these cases, the only option to assess these compounds is in-silico toxicological assessments, based upon structure activity relationships. However, since the results of actual toxicological testing are always much more reliable than in-silico toxicological evaluations, Toxikon has decided to start up specific a R&D programme – called TOX-PACK – to test a list of often occurring E/L-compounds for a basic toxicological evaluation:

  • In-vitro mutagenicity (AMES OECD 471)
  • (In-vivo) acute oral toxicity (OECD 423)
  • Cytotoxicity

The focus of this research will be on chemical compounds where no – or very limited – toxicological information is available. The results of these toxicological tests are included in ‘TOX-PACK Expert Reports’ and will be made available to customers.

"I am particularly thrilled about this TOX-PACK R&D programme because it combines the analytical know-how and pharmaceutical polymer expertise of Toxikon with in vitro and in vivo testing, which has been the core business of the Toxikon group for nearly 35 years," Dr. Desai explains. "As a CRO, we are the only provider of the combined analytical and toxicological testing, which makes our offering unique."

To learn more please contact Toxikon.

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