Iso-Insulin ELISA ( ), Brochure

Transcription

1 Iso-Insulin ELISA ( ), Brochure Interest in any of the products, request or order them at Bio-Connect Diagnostics. Bio-Connect Diagnostics B.V. T NL +31 (0) T BE +32 (0) Begonialaan 3a F NL +31 (0) F BE +32 (0) TE Huissen E info@bio-connectdiagnostics.nl The Netherlands W

2 EXOGENOUS INSULIN MEASUREMENT Mercodia Iso-Insulin ELISA Pharmacokinetics (PK) and Pharmacodynamics (PD) Insulin Delivery Systems Analog Comparisons Endogenous vs. Exogenous Insulin WHEN ACCURACY MATTERS

3 MERCODIA ISO-INSULIN ELISA ( ) Insulin replacement is critically important for patients with type 1 diabetes mellitus (T1DM). Studying insulin analogues requires an assay that can detect these peptides in vitro and in vivo. Many human insulin assays do not detect insulin analogues. Therefore, scientists need a well-characterized assay that can be used to measure these exogenous insulins. The Mercodia Iso-Insulin ELISA measures common as well as non-commercially available insulin analogues and comes with full cross-reactivity data. Hence, this assay has been the solution for scientists in academic, biotech and pharmaceutical research laboratories across the globe. The Mercodia Iso-Insulin ELISA has been used in a variety of studies: Insulin Formulations Ultra-rapid-acting insulins Novel insulin analogues Insulin biosimilars Alternate Routes of Insulin Administration (ARIA) Inhaled insulin Sublingual insulin Transdermal insulin Insulin pumps Bridge Pre-Clinical and Clinical Studies with an Accurate and Robust Assay Pre-Clinical Models A collaborative group in Taiwan used the Mercodia Iso-Insulin ELISA to measure the biodistribution of aspart (NovoRapid ) after oral delivery using a nanoparticle system vs. subcutaneous administration in diabetic rats. 1 Collaborative Work Mercodia also worked closely with Sanofi-Aventis to develop a method for specific determination of glargine (Lantus ) and its metabolites, in addition to endogenous insulin. The cross-reactivity of glargine (Lantus ) and its metabolites, M1 and M2, were determined in the Mercodia Iso-Insulin ELISA. The Mercodia Insulin ELISA was run as a sequence assay to prevent any detection of glargine (Lantus ), M1 and M2. Combining these two assays enables determination of exogenous and endogenous insulin in the same sample. 2,6

4 Pediatric Patients A group led by Dr. William Tamborlane at Yale University conducted aspart (NovoRapid ) PK and PD studies in prepubertal and pubertal subjects with T1DM, using the glucose clamp technique. In this study, the Mercodia Iso-Insulin ELISA was used to determine concentrations of aspart (NovoRapid ) in pump-treated pediatric patients. 3 Adult Patients Dr. Hans J. Arnqvist and his team at Linköping University examined the contribution of bedtime intermediateacting insulin on the morning plasma insulin profiles after injection of rapid-acting lispro (Humalog ) or aspart (NovoRapid ) in patients with T1DM. To distinguish between human insulin and insulin analogues, Dr. Arnqvist and his team used the Mercodia Iso-Insulin ELISA and Mercodia Insulin ELISA. 4 Translational Work Biodel Inc. needed to compare the PK and PD properties of new formulations of Linjeta to identify modifications that would improve tolerance and the timing of early absorption. The Mercodia Iso-Insulin ELISA was used to determine the PK and PD properties in pigs and humans. 5 Cross-Reactivity to Insulin Analogues TRADENAME ANALOGUE MERCODIA ISO-INSULIN ELISA (%) MERCODIA INSULIN ELISA (%) NovoRapid Insulin aspart Levemir Insulin determir 28 < Lantus Insulin glargine 58 24/n.d.* Insulin glargine M1 47 n.d.* Insulin glargine M2 32 n.d.* Apidra Insulin glulisine 123 < Humalog Insulin lispro 112 < *Glargine, M1 and M2 do not cross-react when using the Mercodia Insulin ELISA performed as a sequence protocol. 6 n.d. = not detected References 1. Sonaje et al. (2010) Biomaterials 31: Iso-Insulin ELISA and Glargine handout.pdf ( 3. Swan et al. (2008) Diabetes Care 31: Lindström et al. (2002) Diabetes Care 25: Pohl et al. (2012) Poster presented at ADA Meeting; 2012 June 10; Philadelphia, PA, USA. 6. Carlsson A et al. (2012) Technical Note TN

5 Related Assays CATALOG NO. PRODUCT NAME SAMPLE VOLUME RANGE Mercodia Insulin ELISA 1 x 96 wells Mercodia Insulin ELISA 10 x 96 wells Mercodia Ultrasensitive Insulin ELISA 1 x 96 wells Mercodia Iso-Insulin ELISA 1 x 96 wells Mercodia Proinsulin ELISA 1 x 96 wells Mercodia C-peptide ELISA 1 x 96 wells Mercodia Ultrasensitive C-peptide ELISA 1 x 96 wells* Mercodia Glucagon ELISA 50 µl 50 µl mu/l mu/l mu/l mu/l pmol/l pmol/l pmol/l pmol/l * Contact Mercodia for more information about a unique alternative protocol for measuring extremely low levels of C-peptide. Supplements CATALOG NO. PRODUCT NAME VOLUME ** **Available in the US only. Global Headquarters Mercodia AB Phone Mercodia Diabetes Antigen Control - Human Low and High Mercodia Diabetes Antigen Control - Human Low and High (unassayed)** Mercodia Glucagon Control - Low, Medium, High Mercodia Diabetes Sample Buffer Sales Office USA Mercodia Inc Phone +1 (336) Fax +1 (336) info_usa@mercodia.com Sales Office France Mercodia France SAS Phone x 0.5 ml 2 x 0.5 ml 3 x 0.5 ml 30 ml Sales Office Germany Phone Version 3.1 Article no