Case Study

Introduction

How long do you think it takes for a new drug to get approved in the US? About 12-15 years, that’s roughly 1/3rd duration of the entire professional career for any of us. Next, how much investment do you think is required to bring a new drug to market? ~$1 Billion, that’s equivalent to employing 665+ employees at the annual salary of $100k for 15 years. Simply put, approval of...

Introduction

Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed and validated methods to quantitatively detect analytes and metabolites within biological matrices such as serum, plasma, urine,...

It’s no secret that scientific research laboratories around the world aren’t exactly the most eco-friendly institutions. High energy utilization, single use products, and continuous chemical consumption are among the many routine ways a laboratory can hurt the environment. However, we can proactively address improper laboratory practices to lessen their adverse impact on the environment.

In an ideal scenario, a typical solution that is equally injected and then tested multiple times should have same signal response. In practice, however, the signal will likely vary due to different analytical conditions. These conditions include inconsistency in sample preparation, injection volume, mass spectrometer, and matrix effects. Hence, it is necessary to include an Internal Standard...

Introduction

Matrix Effects are the suppressing or enhancing properties of a co-eluting compound from a biological matrix on the primary signal response of the target analyte. In several liquid chromatography-tandem mass spectrometry (LC-MS) biological studies, Matrix Effects can suppress the ion intensity by interfering with target analyte ionization. Compounds with high mass, polarity, and...

Background

Dried blood spot (DBS) analysis has been practiced for ~100 years[1], but has started gaining traction as an alternate to traditional assays only this decade. Human / Animal blood is spotted on prepared filter cards, the cards are air dried, stored in airtight bags, and shipped under administered humidity and temperature levels[2]. For bioanalytical analysis, we punch tiny discs out...

Background

Bioanalytical assays are widely used to quantify drugs and their metabolites in a variety of biological matrices. Incurred sample reanalysis (ISR) has steadily gained popularity as a quality assessment tool for bioanalytical assays. ISR is repeated measurement of analyte within a selected sample set from dosed subjects in separate runs on different days to establish result...

Background

Sample preparation and liquid chromatography are sometimes ignored during method development and validation given the highly selective Multiple Reaction Monitoring (MRM) in LC – MS analysis. For a rugged method, however, we must pay attention to all sample cleanup and chromatography steps. Additionally, this approach safeguards reliability and minimizes tweaking while transitioning...

New Haven, CT, Aug 01, 2018 – NorthEast BioLab, a boutique bioanalytical services contract research organization (CRO), today announced Abhay Pandey as their VP of Business and Corporate Development.

New Haven, CT, Aug 01, 2018 – NorthEast BioLab, a boutique bioanalytical services contract research organization (CRO), today announced expansion of their laboratory facilities.