Spotlights

ADC bioanalytics

Antibody-drug conjugates (ADCs) combine targeted monoclonal antibodies with potent cytotoxic agents. Over the last decade, the number of ADCs in drug development has been increasing. A ...

Bioanalytical support for AAV therapies

As adeno-associated virus (AAV) therapies gain traction in the gene therapy market, the need for specialized bioanalytical support becomes increasingly critical. Bioanalysis in ...

Immunogenicity assessment of therapeutic proteins

Bioanalysis of immunogenicity is critical for the development of therapeutic proteins, as immunogenicity can affect both the safety and efficacy of biologic drugs. High-quality ...

Evolving best practices in flow cytometry to support drug development

The biomarker landscape is evolving at a breakneck pace, accelerated by unmet needs as well as a rapidly evolving technology landscape. This is perhaps most evident in the field of flow ...

LBA vs LC-MS/MS

LBA has been considered the gold standard for bioanalytical qualitative and quantitative analysis of ADA, NAb, TAb and total ADC. It offers low-cost equipment, high throughput and ...

Biomarker bioanalysis in oncology drug development and personalized medicine

Technological advancement and the discovery of various biomarkers have made personalized/precision medicine a reality. Biomarkers are measurable indicators of biological processes and ...

The practical challenges of new modalities in bioanalysis

Hybridization assays are readily used as bioanalytical tools to support pharmacokinetic, toxicokinetic and animal biodistribution studies for oligonucleotide drug programs. Reliable, ...

LBAs and critical reagents

When making pivotal decisions in support of drug development, data from ligand-binding assays (LBAs) can be difficult to manage. The robustness and reliability of the assay is directly ...

Accelerating vaccine development

Vaccine development is a long and intensive process requiring several testing stages. Multiple assays are required to measure candidates’ immune responses to ensure that the ...

Cell and gene therapy products

In recent years, cell and gene therapies have offered new and promising therapeutic modalities for the treatment of rare, inherited and acquired diseases. While both cell and gene ...

Small molecule analysis using MS

Mass spectrometry (MS) is a powerful tool that routinely aids in the identification and quantification of the metabolites of drugs and drug candidates, and their interactions. In the ...

Biosimilars

A biosimilar is a subsequent version of an innovator biologic product. Biosimilars are characterized by having the same amino acid sequence as the originator therapeutic and also nearly ...

Precision medicine and companion diagnostics

Precision medicine involves the application of cutting-edge science to develop therapies that are tailored for patients. The approach considers individual variability in genes and ...

DMPK Spotlight

During drug development, drug metabolism and pharmacokinetic (DMPK) profiles of prospective new drugs are evaluated in order to help validate toxicology studies, understand drug-drug ...

LC–MS in early discovery-stage workflows

LC–MS is a versatile method used to separate compounds based on their weight and affinity for the mobile and stationary phases of the column. Proteins and complex peptides, which are ...

Metabolomics

Metabolomics is defined as the identification and quantification of metabolic products in a biological system. In the past the use of this technology has aided the identification of ...

Biomarker discovery

A biomarker is a protein or small molecule indicative of homeostasis or a disease state, the concentration of which can indicate disease progression or a response to a therapeutic ...

Chromatographic separation technologies

Chromatographic separation enables the isolation and purification of specific target compounds. It involves different separation procedures that selectively retain analytes on a solid ...

HRMS in DMPK

The aim of DMPK is to enable scientists to learn the safety and efficacy of new molecular entities. HRMS is an important analytical tool used to study DMPK that continues to gain ...

Ligand binding assays

Ligand binding assays (LBA) is a key method used for the quantification of large molecules, such as proteins, antibodies and biosimilars, in pharmacokinetic (PK), toxicokinetic (TK), ...

Flow cytometry

Flow cytometry is a versatile tool used for analyzing parameters on an individual cell basis. Originating in the 1950s, the technology measures fluorescence associated with cells, using ...

Cell and gene therapy

Gene therapy is an experimental technique that involves the delivery of therapeutic nucleic acid polymers into a patient’s cells to treat or prevent a disease. Gene therapy has ...

Proteomics

In order to explore the most recent developments in proteomics, this Spotlight will highlight the advances and challenges faced during method development, validation and samples ...

Immunogenicity

The immunogenicity of biologics is a significant concern, which can affect safety and efficacy. In this Spotlight we will explore recent developments in immunogenicity, highlight key ...

Validation of biomarkers

A biomarker is a protein or small molecule indicative of homeostasis or a disease state, the concentration of which can indicate disease progression or a response to a therapeutic ...

Large molecule quantification by LC–MS

In order to explore the most recent developments in large molecule quantification in regulated bioanalysis by LC–MS, this Spotlight will highlight the advances and challenges faced ...

Emerging technologies: DMPK and bioanalysis of small molecules

In order to explore the key developments and technologies in this ever-evolving field, Bioanalysis Zone will be featuring a Spotlight on the emerging technologies in DMPK and the ...

Oligonucleotides

In this Spotlight we will be exploring the recent developments and the unique challenges that oligonucleotides bring to the bioanalytical community. Oligonucleotide therapeutics ...

Bioanalysis of biopharmaceuticals and biomarkers

In this Spotlight we explore the recent developments in the bioanalysis of biopharmaceuticals and biomarkers. As the pharma and life sciences industries continue to increase investment ...

Future Trends in Outsourcing

In last year’s Bioanalysis Zone survey on ‘Future Trends in Outsourcing’, part of a Spotlight of the same name, we asked experts with Pharma backgrounds to rank the most important ...

Quantitative HRMS

Welcome to the Bioanalysis Zone Spotlight on Quantitative HRMS! HRMS has been available for a long time; originally it was applied in qualitative applications, however the introduction ...

Hybrid LBA/LC-MS

Welcome to the Bioanalysis Zone Spotlight on Hybrid LBA/LC-MS! LBA is historically the gold standard for biologics and is employed extensively in their analysis. LC–MS, in contrast, is ...

Large molecule analysis by LC-MS

Welcome to the Bioanalysis Zone Spotlight on Large molecule analysis by LC-MS! In recent years there has been an increase in large-molecule therapeutics due to their target specificity, ...

Biomarkers (and biosensors)

Welcome to the Bioanalysis Zone Spotlight on Biomarkers (and biosensors)! A biomarker is “a characteristic that is objectively measured and evaluated as an indicator of normal biologic ...

LC-MS

Welcome to the Bioanalysis Zone Spotlight on LC-MS! LC-MS is used in the pharmaceutical industry to provide quantitative measurements of an active drug and its metabolites to generate ...

Antibody–drug conjugates

Welcome to the Bioanalysis Zone Spotlight on antibody-drug conjugates (ADCs)! ADCs are dynamic, heterogeneous mixtures typically consisting of a cytotoxic drug covalently bound to a ...

Automation

Automation can increase throughput while maintaining quality; this increase in efficiency can lead to a reduction in the cost of bioanalysis. Along with many other benefits, automation ...

Metabolomics

Welcome to the Bioanalysis Zone Spotlight on Metabolomics! In recent years, metabolomics has become a ‘hot topic’ in bioanalysis; the interest in metabolomics within the bioanalytical ...

Microsampling: the road ahead

Welcome to the Bioanalysis Zone Spotlight on Microsampling: the road ahead! There has been continued interest in microsampling both in the literature and at scientific meetings in ...

Hot topics in large molecule bioanalysis

Welcome to the Bioanalysis Zone Spotlight on ‘Hot topics in large molecule bioanalysis’! Hot on the heels of our hugely popular ‘Overcoming matrix effects’ Spotlight, Bioanalysis Zone ...

Overcoming Matrix Effects

Welcome to the Bioanalysis Zone Spotlight on Overcoming Matrix Effects! Matrix effects are a major issue for the development and validation of bioanalytical methods. Bioanalysis Zone ...

What is the future of dried blood spots?

Dried blood spots (DBS) have been one of the hottest topics in bioanalysis in recent years. The potential benefits are clear in terms of 3R principles for animal testing, cost savings, ...