Gyrolab Spin Blog

This year, Bioprocess International West brings together attendees from different departments to share challenges and discuss the “solutions needed to improve the speed, lower the cost and increase the quality of biologics development”. We are proud to announce a new system that is aimed at doing exactly that: Gyrolab® xPand.

Singlicate Gyrolab immunoassays prove their worth (again)

In a previous post, ‘How to get it right first time’, we looked at the reliability and reproducibility of Gyrolab™ assays that lead to the idea of running singlicates instead of duplicates (Clark et al, 2016). This publication inspired Hao Jiang and colleagues in a group based at Bristol-Myers Squibb in Princeton, USA to apply Gyrolab technology to run assays of their monoclonal antibody in singlicate in a clinical study. They were encouraged by the results.

Guidance with immunoassays from initial assay design to final validation

The drive to achieve regulatory approval of protein-based drugs quickly and efficiently demands methods that can deliver reliable data to support studies in pharmacokinetics, toxicokinetics, pharmacodynamics, biomarker analysis, and immunogenicity. This need has powered the development of a wide and somewhat perplexing range of ligand binding assays (LBAs) and technology platforms designed to function in a regulated environment, from non-clinical studies to post approval. Added to that, developing an assay that is ready for validation can be a real challenge. If you need guidance in this area then you would do well to read ‘Ligand Binding Assays in the Regulated Bioanalytical Laboratory’, a book chapter authored by Johanna Mora , Charles Hottenstein, and Binodh DeSilva at Bristol-Myers Squibb and GlaxoSmithKline (1).

The extreme reliability of Gyrolab assays

Whatever your needs in immunoassays, you will almost certainly appreciate an assay that consistently delivers high precision and accuracy. Scientists at Pfizer have reported a retrospective study of pharmacokinetics (PK) data that highlights the reliability of Gyrolab assays.

Immunoassays support research by coping with a difficult matrix

A number of serious eye diseases, such as neovascular age-related macular degeneration (AMD) and diabetic macular edema, involve increase in the leakage of blood vessels in the eye. This is caused by vascular endothelial growth factor (VEGF) and while such diseases can be treated with protein drugs that neutralize VEGF, the drugs must be administered frequently. A research group has developed an elegant approach that significantly extends the half-life of the drugs. This exciting work involved handling a challenge that is common to much of eye research – running immunoassays on precious samples in difficult matrices.

Gyrolab xP workstation generates high quality data faster

As the pace of drug development increases, so does the demand on rapid and efficient generation of bioanalytical data in a regulated setting. In testing six ligand-binding assays on Gyrolab™ xP workstation, Rong Liu and her colleagues at Bristol-Myers Squibb have found that the system delivers the performance they need. This included high run and incurred sample reanalysis (ISR) pass rates for 5000 samples in a fraction of the time required for non-automated plate-based methods.

Rapid in-solution equilibrium approach to K_D determination of biotherapeutic drug candidates

 
During our latest webinar, Johan Engström, Senior Scientist at Gyros Protein Technolgies gave a short introduction to Gyrolab technology and how you to set up and evaluate classical in-solution equilibrium experiments for determination of sub-nanomolar K_D’s and active concentrations of interactants. Johan also gave examples of determinations of picomolar affinities for several marketed TNFα antagonists.

How Design of Experiments (DOE) boosts productivity

Bioanalytical laboratories often need to quickly develop robust immunoassays to support studies with tight timelines. Immunoassay performance is governed by many factors, such as reagent concentrations and sample dilution, and the classic experimental approach to improving assay performance involves changing one factor at a time. This approach is time consuming, misses important interactions between factors, and seldom leads to an optimal assay. There is an alternative, very powerful approach that has been used in many industries and applications to optimize processes – Design of Experiments (DOE). DOE has been successfully applied to immunoassay development by a number of research groups, including those using Gyrolab technology.

A generic detection reagent makes all the difference

Pharmacokinetic (PK) studies of therapeutic proteins in early preclinical development demand great flexibility in bioanalytical methods. This is a real challenge during lead candidate selection when, for example, limited amounts of specific reagents must be labeled for immunoassays. Gregor Jordan and his colleagues at the Pharma Research & Early Development (pRED) department at Roche in Munich, Germany saw the advantages of transferring their ELISAs to the Gyrolab™ platform – low reagent consumption, semi-automation and fast assay turnaround – but wanted to go one step further in conserving critical resources. They therefore developed a generic detection reagent that would allow them to use the same antibody reagents on both ELISA and Gyrolab platforms.

Gyrolab system delivers

Determining the immunogenic potential of a therapeutic antibody is a regulatory requirement during clinical development since anti-drug antibodies (ADA) can cause undesirable effects, ranging from loss of drug exposure and efficacy to serious adverse events. Justine Brose and her colleagues at Novimmune SA, Geneva, Switzerland evaluated four platforms to determine which platform and sample pre-treatment procedures could deliver a fit-for-purpose assay for ADA analysis to determine the immunogenicity of the therapeutic antibody Novimab. Of the platforms tested (ELISA and Gyrolab, Meso Scale Discovery, and AlphaLISA platforms) only Gyrolab and MSD platforms met all of their pre-specified assay requirements.