Emerging Technologies to Increase Ligand Binding Assay Sensitivity
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 1
Abstract
Ligand binding assays (LBAs) have been the method of choice for protein analyte measurements for more than four decades. Over the years, LBA methods have improved in sensitivity and achieved larger dynamic ranges by using alternative detection systems and new technologies. As a consequence, the landscape and application of immunoassay platforms has changed dramatically. The introduction of bead-based methods, coupled with single molecule detection standardization and the ability to amplify assay signals, has improved the sensitivity of many immunoassays, in some cases by several logs of magnitude. Three promising immunoassay platforms are described in this article: Single Molecule Counting (SMC™) from Singulex Inc, Single Molecule Arrays (Simoa™) from Quanterix Corporation, and Immuno-PCR (Imperacer®) from Chimera Biotec GmbH. These platforms have the potential to significantly improve immunoassay sensitivity and thereby address the bioanalytical needs and challenges faced during biopharmaceutical drug development.
Authors and Affiliations
Saloumeh K. Fischer, Alison Joyce, Mark Spengler, Tong-Yuan Yang, Yao Zhuang, Marianne Scheel Fjording, Alvydas Mikulskis
Keywords
Related Articles
- EP ID EP680895
- DOI 10.1208/s12248-014-9682-8
- Views 82
- Downloads 0
Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report
Modified release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced ef...
Haste Makes Waste: The Interplay Between Dissolution and Precipitation of Supersaturating Formulations
Contrary to the early philosophy of supersaturating formulation design for oral solid dosage forms, current evidence shows that an exceedingly high rate of supersaturation generation could result in a suboptimal in vitro...
Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation
It is often necessary to adjust for detectable endogenous biomarker levels in spiked validation samples (VS) and in selectivity determinations during bioanalytical method validation for ligand-binding assays (LBA) with a...
Therapeutic Paint of Cidofovir/Sucralfate Gel Combination Topically Administered by Spraying for Treatment of orf virus Infections
The aim of the research was to study a new cidofovir/sucralfate drug product to be used as a spray for treating the mucosal and/or skin lesions. The product, i.e., a water suspension of sucralfate (15% w/w) and cidofovir...
Performance of Methods for Handling Missing Categorical Covariate Data in Population Pharmacokinetic Analyses
The online version of this article (doi:10.1208/s12248-012-9373-2) contains supplementary material, which is available to authorized users.