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Cerilliant Introduces Snap-N-Spike® Internal Standards of Immunosuppressants

ROUND ROCK, TEXAS – August 11, 2011 – Cerilliant announces the successful synthesis of Everolimus-D4 and introduces three new Snap-N-Spike® internal standards for therapeutic drug monitoring of immunosuppressants. These Certified Spiking Solutions® of ascomycin, cyclosporin D, and everolimus-D4 standards are offered in acetonitrile at a concentration of 1.0 mg/mL for ascomycin and cyclosporin D and 100 µg/mL for everolimus-D4 and are suitable for quantitation of immunosuppressant levels using LC-MS/MS testing methods.

Per the U.S. Department of Health and Human Services (HHS) approximately 24,000 organ transplants occurred in the U.S. in 2010. The World Health Organization estimates that worldwide approximately 100,000 organ transplants occur annually based on 2008 data. Per HHS data transplant recipients still living 5 years post transplant has increased to 69% for kidney, 75% for heart, and 74% of liver recipients.(1)

Immunosuppressant drugs have impacted increasing these long-term survival rates. However, absorption and metabolism of immunosuppressants can vary significantly between individuals and within a single individual with changes in age, diet, time post transplant, concurrent drug therapies, and other factors. According to a recent article in Clinical Laboratory News, immuosuppressive drug bioavailability can vary inter- and intra-individually by 5-40%(2).

Laboratories play a critical role in achieving and improving long-term survival rates through TDM of immunosuppressants assisting the physician in maintaining the delicate balance between toxicity and therapeutic levels necessary to prevent organ rejection. Many clinical laboratories have adopted LC-MS/MS technology for the quantitation of immunosuppressant levels in patient whole blood samples due to improved sensitivity and specificity and to eliminate issues with cross reactivity of metabolites common with immunoassay methods. The presence of an internal standard in the sample is important to minimize variability from sample-dependent changes in extraction or different ionization characteristics.

Effectiveness of the internal standard is dependent on the extent of its structural difference from the analyte of interest. Ascomycin, a structural analog of tacrolimus, is often used as an internal standard in LC-MS/MS testing methods for tacrolimus and sirolimus. Cyclosporin D is selected as an internal standard for cyclosporine A monitoring due to its very similar structure. For everolimus testing, Cerilliant synthesized and certified everolimus-D4 as an internal standard for analysis of everolimus and other immunosuppressants by mass spectrometry with the deuterium substitution in everolimus-D4 offering the best choice to minimize variability and mitigate potential interferences.

Cerilliant offers these internal standards as Certified Spiking Solutions® in a convenient, efficient, and shelf-stable format which eliminates the need for laboratories to perform weighing operations of toxic materials and allows the laboratory to prepare accurate calibrators and controls by pipetting a known concentration of analyte into the sample matrix before use.

Sherri Pogue, Cerilliant President, stated, "Organ transplants have improved patient lives and the demand only continues to grow with more than 111,000 people currently on waiting lists in the U.S. alone(1). Due to the narrow therapeutic range of immunosuppressive therapy and the variability in bioavailability, laboratories performing therapeutic monitoring need highly accurate, dependable, yet affordable solutions. We are pleased to offer these new certified internal standards to aid laboratories and researchers in accurately quantitating immunosuppressant levels.”

Cerilliant offers a wide selection of Certified Spiking Solutions® for use in clinical testing, therapeutic drug monitoring, toxicology, forensic analysis, and research applications including Snap-N-Spike® solutions of catecholamines, vitamin D, steroids and hormones, cardiac and other therapeutic drugs, ethanol (blood alcohol), pain-management drugs, and drugs-of-abuse including parent drugs, metabolites, and internal standards. Cerilliant is accredited to ISO Guide 34 and ISO 17025 and certified to ISO 13485 and ISO 9001. Our quality system incorporates cGMP and GLP requirements.


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