In the Zone

In the Zone: the importance of monitoring assay performance and maintenance

Upon validation of any assay, monitoring its performance is a critical portion. There are two major aspects of assay monitoring: assay performance and assay maintenance. Monitoring ...

In the Zone: the importance of tailored sample preparation methods

Sample preparation is a foundational element for precise analysis across regulated industries like pharmaceutical, cosmetics, medical devices or food and beverage, ensuring product ...

In the Zone: oligonucleotide therapy quantitation

The development of oligonucleotide therapies for the treatment of genetic diseases through modulation of gene expression is rapidly expanding, with 22 approved therapies currently and a ...

In the Zone: automating analytical methods for gene therapy

Gene therapy is one of the most innovative therapies in the world. By the end of 2022, there were 24 gene therapies approved (five of which happened in 2022) and more than 2000 clinical ...

In the Zone: overcoming hurdles for iChem workflow automation

Challenges within the pharmaceutical industry including clinical study mix, sample volumes and virtualization, unique assays, talent scarcity and rising cost pressures on lab ...

In the Zone: ELISpot assays for evaluating safety

A critical aspect of testing therapeutic drugs that treat human disease is evaluating their safety post-administration. Traditionally, this has been achieved by monitoring key ...

In the Zone: clinical development for oncology

Next generation sequencing panels are useful tools for diagnostics, hereditary risk assessment, prognosis and treatment selection and support the delivery of personalized treatment for ...

In the Zone: Research Regulations – China NMPA

Supporting new drug application submissions using manual data will become increasingly obsolete as electronic versions can offer increased efficiency, traceability and data preservation ...

In the Zone: smart biomarker assays

Biomarkers can belong to many diverse classes of molecules, such as lipids, steroids, sugars, even peptides and proteins. Most biomarkers are amenable to LC-MS/MS, however, very polar ...

In the Zone: ADA assessment and detection

The potential for a drug to induce an immune response in patients may be a critical factor in its clinical success. Anti-drug antibodies (ADAs) can impact the efficacy of the drug as ...

In the Zone: bioanalytical matrices – disruption and solutions

The COVID-19 pandemic has strained the biological matrix supply chain. An upsurge in demand driven by numerous COVID-19 therapeutic and vaccine development programs to combat the ...

In the Zone: flow cytometry for cell and gene therapies

As a bioanalytical method capable of detecting and measuring the physical and chemical properties of a population of cells, traditional flow cytometry has remained a mainstay of the ...

In the Zone: biomarkers and Alzheimer’s disease

Alzheimer’s disease is a devastating neurodegenerative disease and the only one of the top 10 deadly diseases that have almost no treatment. FDA approved ADUHELM® from Biogen (MA, ...

In the Zone: iChem workflows and automation

Several challenges are driving the need for greater efficiencies and flexible iChem automation in today’s immunochemistry environment, including COVID-19 pandemic-related effects, ...

In the Zone: bridging the LBA and LC−MS disciplines for hybrid assays

The increasing complexity of large molecule therapeutics has driven the need for additional approaches to quantitation in regulated bioanalysis where challenges with traditional ligand ...

In the Zone: cell-based assays

Cell-based assays can be utilized throughout the drug development process for a faster translation to clinical trials. By utilizing cell cultures as model systems, cell-based assays ...

Special focus: nitrosamines

The pharmaceutical industry is facing an ongoing issue with genotoxic impurities (GTIs). Since 2018, we have witnessed genotoxic impurities affect several drugs, including those used ...

In the Zone: ocular cell and gene therapies – why the eye?

The last 10–15 years have seen an increased interest in cell and gene therapies (CGTs). CGTs refer to a group of drug products or therapeutics in which the active pharmaceutical agent ...

In the Zone: Gyrolab vs ELISA

Plate-based enzyme-linked immunosorbent assays (ELISAs) are widely used due to their advantages of simplicity, high specificity and sensitivity, and technical simplicity, but are ...

In the Zone: automation

Automating sample preparation for complex assays pays dividends to scientists and project management, as liquid handlers can streamline workflows and provide audit trails documenting ...

In the Zone: the acoustic ejection mass spectrometry age

High-throughput screening of candidate compounds during drug discovery has been hindered by the limitations of traditional liquid chromatography. Acoustic Ejection Mass Spectrometry ...

In the Zone: phosphorylated biomarkers

An integral part of the drug development process is the proper identification of drug action and mechanism. One method to understand the pharmacodynamic effects of a drug on specific ...

In the Zone: virtual audits

As research continues throughout the COVID-19 pandemic, the need to continue operations as usual while maintaining regulatory compliance, presents unprecedented challenges for the ...

COVID-19 blood biomarkers for screening and treatment

In the Zone: the COVID-19 vaccine effort

In this feature we focus on the COVID-19 vaccine effort and explore how do we decide that a vaccine is effective? Within this feature, we will show the various steps within the ...

In the Zone: biomarker assays

Reliable diagnostic, prognostic, predictive, pharmacodynamic and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing and monitoring. Being able to ...

In the Zone: data management

Data management is a common terminology used in almost all industries. It comprises all disciplines related to managing data as a valuable resource. Regulated bioanalytical laboratories ...

In the Zone: the use of singlicate analysis in LBAs

Ligand-binding assays (LBAs) including plate-based enzyme-linked immunosorbent assays (ELISAs) are a mainstay of the bioanalytical quantitation of biotherapeutic drugs in ...

In the Zone: coronavirus

With coronavirus disease 2019 (COVID-19) shutting down countries and economies, the world is expectantly looking at scientist to come up with a solution. Although the novel severe acute ...

In the Zone: ChipCytometry

To develop a thorough understanding of the biological problems that face the bioanalytical field today, we need to measure and visualize increasingly complex biochemical and ...

In the Zone: HRMS versus QqQ

Traditionally, triple quadrupole mass spectrometry (QqQ) is viewed as the workhorse of the bioanalytical laboratory. However, developments in high-resolution mass spectrometry (HRMS) ...

In the Zone: gene therapy – the era of AAV

Thousands of people are born with diseases caused by genetic defects every year. A gene mutation can result in the absence or reduced function of a critical protein. Less than 10% of ...

In the Zone: immunogenicity

Pathogen immunity has long been determined by antibody-detection assays, however, in many situations, measuring T-cell immunity to specific pathogens can provide physicians with ...

In the Zone: The bioanalyst – challenges and solutions

Assay development enables a drug or biochemical to be tested or measured. When analyzing a peptide of interest, it is important to choose and develop assays that are specific, sensitive ...

In the Zone: Peptide Bioanalysis Sample Preparation

Bioanalysis is a critical part of the discovery and development of peptide therapeutics. LC–MS is an established technique for quantifying peptides; however, analysis of target analytes ...

In the Zone: antibody-drug conjugates

Bioanalytical strategies for PK analysis of antibody–drug conjugate therapeutics using LC–HRMS & LC–MS/MS Antibody–drug conjugates (ADCs) combine the best of two modalities: toxin ...

In the Zone: CAR-T cells

Chimeric antigen receptor T-cell therapy, known as CAR-T cell therapy, is an immunotherapy treatment option for cancer, whereby a patient’s T-cells are purified and manipulated in the ...

In the Zone: alternative matrices

Whole blood, plasma, serum and urine samples are often utilized as key matrices for bioanalytical research, but what happens when these samples are inappropriate or unattainable for a ...

In the Zone: flow cytometry

Flow cytometry is a versatile tool used for analyzing parameters on an individual cell basis. The technology measures fluorescence associated with cells, using refracted or emitted ...

In the Zone: drug metabolism

Studying drug metabolism is vital in understanding the time course of a drug, critical dosages, toxicology of drug metabolites and other interactions of drug combinations. The rate a ...

In the Zone: biotransformation

The biotransformation process plays a significant role in determining the fate of prospective drugs. The way that compounds are transformed from one form to another has a big impact on ...

In the Zone: old vs new technologies

Investing in new technologies in the field of bioanalysis has its obvious advantages. New technologies often offer improved data quality and accuracy; better efficiency cutting costs ...

In the Zone: immuno-oncology

Immuno-oncology is an evolving approach that harnesses a patient’s own immune system to help treat cancer. This treatment modality has great potential to enable the specific destruction ...