Bio-assays for the analysis of insulin

Trethewey, John

doi:10.1016/0731-7085(89)80083-4

Cited by 15 publications

(5 citation statements)

References 14 publications

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“…A relevant analogy would be the case of insulin [34]. When first produced, the issue of how to insure consistent batch-to-batch biological potency was a great concern.…”

Section: Resultsmentioning

confidence: 99%

“…It was determined that the only way to address this issue for such a complex macromolecule was a bioassay. To assess the biological potency of insulin, blood glucose depression in rabbits was initially used, then convulsive activity in mice, and finally blood glucose depression in mice (this is the most commonly used test of insulin potency today [34]). The FDA recommends that the potency of cellular and gene therapy products be evaluated by bioassay, or by analytical assay that is a validated surrogate of biological activity, and this potency assay should be included as one of the lot release criteria [35].…”

Section: Resultsmentioning

confidence: 99%

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Translational considerations for cancer nanomedicine

Stern

Hall

et al. 2010

Journal of Controlled Release

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There are many important considerations during preclinical development of cancer nanomedicines, including: 1) unique aspects of animal study design; 2) the difficulties in evaluating biological potency, especially for complex formulations; 3) the importance of analytical methods that can determine platform stability in vivo, and differentiate bound and free active pharmaceutical ingredient (API) in biological matrices; and 4) the appropriateness of current dose scaling techniques for estimation of clinical first-in-man dose from preclinical data. Biologics share many commonalities with nanotechnology products with regard to complexity and biological attributes, and can, in some cases, provide context for dealing with these preclinical issues. In other instances, such as the case of in vivo stability analysis, new approaches are required. This paper will discuss the significance of these preclinical issues, and present examples of current methods and best practices for addressing them. Where possible, these recommendations are justified using the existing regulatory guidance literature.

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“…A relevant analogy would be the case of insulin [34]. When first produced, the issue of how to insure consistent batch-to-batch biological potency was a great concern.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Translational considerations for cancer nanomedicine

Stern

Hall

et al. 2010

Journal of Controlled Release

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show abstract

“…Both assays required a 15 or more mice and have a limited linear range. But both assays provide quantitative data which, like the first assays for insulin based on induction of hypoglycemic seizures in rabbits [52], are a very useful first step. Also, the results suggest levels of mRNAs for TSG-6 in MSCs may in themselves be useful (Fig.…”

Section: What Is Needed For the Field To Move Forward?mentioning

confidence: 99%

The exciting prospects of new therapies with mesenchymal stromal cells

Prockop

2017

Cytotherapy

123

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From the outset, it was apparent that developing new therapies with mesenchymal stem/stromal cells (MSCs) was not a simple or easy task. Among the earliest experiments was administration of MSCs from normal mice to transgenic mice that developed brittle bones because they expressed a mutated gene for type 1 collagen isolated from a patient with osteogenesis imperfecta. The results prompted a clinical trial of MSCs in patients with severe osteogenesis imperfecta. Subsequent work by large numbers of scientists and clinicians has established that, with minor exceptions, MSCs do not engraft or differentiate to a large extent in vivo. Instead the cells produce beneficial effects in a large number of animal models and some clinical trials by secreting paracrine factors and extracellular vesicles in a “hit and run” scenario. The field faces a number of challenges, but the results indicate that we are on the way to effective therapies for millions of patients who suffer from devastating diseases. This report was presented by the Author on receipt of the Career Achievement Award in Cell Therapy from the International Society for Cellular Therapy. Singapore, May 25, 2016.

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“…Present analytical methods for the detection of insulin include bioassays, immunoassays and chromatography. The development of bioassays – and immunoassays – for the detection of insulin has been well reported in the literature. Of these, radioimmunoassays (RIA) – and enzyme-linked immunosorbent assays (ELISA) – are the most commonly used methods.…”

Section: Introductionmentioning

confidence: 99%

Electrochemical Study of Insulin at the Polarized Liquid−Liquid Interface

2008

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This paper reports on the electrochemical behavior of bovine insulin at the interface between two immiscible electrolyte solutions (ITIES). The voltammetric ion-transfer response obtained in the presence of insulin was dependent on the aqueous phase pH conditions and on the nature of the organic phase electrolyte employed in experiments. Optimal detection was obtained at acidic pH below the isoelectric point of insulin where it was positively charged. A shift in transfer potentials to lower potential values was observed with decreasing hydrophobicity of the anion of the organic phase electrolyte. No ion-transfer response was observed at pH values of the aqueous phase above the isoelectric point, where insulin was negatively charged. These results suggest that the voltammetric response is due to ion-pairing interactions at the ITIES between positively charged insulin and the hydrophobic anion of the organic phase electrolyte, together with adsorption of the ion-pair at the interface. The voltammetric response was obtained for insulin at concentrations down to 1 muM. These results show that electrochemistry is useful in studying the behavior of this important protein molecule at the polarized water-1,2-DCE interface and provides an alternative detection mode for bioanalytical applications.

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Bio-assays for the analysis of insulin

Cited by 15 publications

References 14 publications

Translational considerations for cancer nanomedicine

Translational considerations for cancer nanomedicine

The exciting prospects of new therapies with mesenchymal stromal cells

Electrochemical Study of Insulin at the Polarized Liquid−Liquid Interface

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