Bile Acid Reference Standards aid drug development.

Press Release Summary:



Cerilliant® Snap-N-Spike® solutions include most routinely tested bile acids and their stable-labeled internal standards. Certified reference materials consist of lithocholic acid, taurocholic acid, and native and deuterium-labeled analogs of cholic acid, chenodeoxycholic acid, deoxycholic acid, and ursodeoxycholic acid. Mass spectrometry-based analyses of bile acids are performed in neonatal screening of inborn errors of BA synthesis and therapeutic monitoring of patient responses to therapy.



Original Press Release:



Cerilliant Introduces Certified Spiking Solutions of Bile Acids



ST. LOUIS, – Sigma-Aldrich Corporation (NASDAQ: SIAL) announced today that the Cerilliant® brand within its Applied Diagnostics and Testing business segment has launched its new bile acid reference standards product line with ten certified Snap-N-Spike®) solutions of the most routinely tested bile acids and their stable-labeled internal standards. These new solution certified reference materials (CRMs) consist of lithocholic acid, taurocholic acid and native and deuterium-labeled analogs of cholic acid, chenodeoxycholic acid, deoxycholic acid, and ursodeoxycholic acid.



Mass spectrometry-based analyses of bile acids (BAs) are performed in neonatal screening of inborn errors of BA synthesis and therapeutic monitoring of patient responses to therapy.(1) BA analysis is also routinely conducted during the pre-clinical phase of drug development to evaluate the hepatotoxicity of candidate drugs.(2)



Research highlighting the influence of BA metabolism in the development of gastroenterologic and hepatic diseases has led to the need for new BA testing applications.(3,4) These emerging applications include the use of BAs as biomarkers for the detection of biliary tract cancer, metabolic profiling of patients with gastrointestinal disorders to optimize treatment outcomes, and identifying additional biomarkers for liver diseases such as obstetric cholestatis, a liver disorder associated with adverse perinatal outcomes.(3,4,5)



Cerilliant offers a wide selection of Certified Spiking Solutions® for use as starting material in the preparation of calibrators and controls in testing applications ranging from clinical diagnostic testing, endocrinology, and clinical chemistry to therapeutic drug monitoring, clinical toxicology, and pharmaceutical research. Cerilliant's catalog offering includes solution CRMs of numerous native and stable-labeled drugs and drug metabolites, as well as endogenous biomarkers. Cerilliant certified reference solutions are manufactured and certified to the highest industry standards including ISO Guide 34, ISO/IEC 17025, and ISO 13485 and are compliant with ISO 15194.



About Cerilliant: Cerilliant Corporation, located in Round Rock, Texas, is a global leader in providing certified reference standards for critical applications. The company has been providing Certified Reference Materials for over 35 years. Cerilliant offers more than 3,000 catalog products and a full range of custom products and services that address the stringent and complex requirements of the pharmaceutical, clinical diagnostic, clinical/forensic toxicology, and natural products industries. Cerilliant sustains a modern, robust quality system, which incorporates cGMP, GLP, and ISO requirements. The company is accredited to ISO Guide 34 and ISO/IEC 17025, is certified to ISO 13485 and ISO 9001, and is compliant with ISO 15194. Cerilliant Corporation is a subsidiary of Sigma-Aldrich. For more information about Cerilliant, visit www.cerilliant.com.



About Sigma-Aldrich: Sigma-Aldrich, a leading Life Science and Technology company focused on enhancing human health and safety, manufactures and distributes 250,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets. With three distinct business units - Research, Applied and SAFC Commercial - Sigma-Aldrich is committed to enabling science to improve the quality of life. The Company operates in 37 countries, has approximately 9,700 employees worldwide and had sales of $2.79 billion in 2014. For more information about Sigma-Aldrich, visit www.sigma-aldrich.com.



Sigma-Aldrich, Cerilliant, Snap-N-Spike, and Certified Spiking Solutions are registered trademarks of Sigma-Aldrich Co. LLC or an affiliated company.



1. Jahnel, J., Zöhrer, E., Scharnagl, H., Erwa, W., Fauler, G. and Stojakovic, T. (2015) Reference ranges of serum bile acids in children and adolescents. Clinical Chemistry and Laboratory Medicine (CCLM). http://www.degruyter.com/doi/10.1515/cclm-2014-1273 (14 September 2015).



2. Van Tonder, J., Steenkamp, V. and Gulumi, M. (2013) Pre-Clinical Assessment of the Potential Intrinsic Hepatotoxicity of Candidate Drugs. New Insights into Toxicity and Drug Testing, 2013: 10.5772/54792.



3. Xu, X., Cheng, S., Ding, C., Lv, Z., Chen, D. and Wu, J. et al. (2014) Identification of bile biomarkers of biliary tract cancer through a liquid chromatography/mass spectrometry-based metabolomic method. Molecular Medicine Reports, 2014: 10.3892/mmr.2014.2973. http://www.spandidos-publications.com/mmr/11/3/2191?text=fulltext (14 September 2015).



4. Holmes, E., Wijeyesekera, A., Taylor-Robinson, S. and Nicholson, J. (2015) The promise of metabolic phenotyping in gastroenterology and hepatology. Nature Reviews Gastroenterology & Hepatology, 12, 458-471. http://www.nature.com/nrgastro/journal/v12/n8/full/nrgastro.2015.114.html (14 September 2015).



5. Egan, N., Bartels, Ä., Khashan, A., Broadhurst, D., Joyce, C. and O'Mullane, J. et al. (2012) Reference standard for serum bile acids in pregnancy. BJOG: An International Journal of Obstetrics & Gynaecology, 119, 493-498.



CONTACT:

Karen Miller

Karen.Miller@sial.com  

Mitzi Rettinger

(512) 310-5105

Mitzi.Rettinger@cerilliant.com



Web Site: http://www.sigmaaldrich.com

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