Gyrolab Spin Blog

Feb 19, 2020 4:30:03 PM

Improving quality and speed in immunoassay development, validation, and routine use

Improving quality and speed in immunoassay development, validation, and routine use

Fast immunoassay validation with high-quality data

 

With R&D returns for large cap biopharma companies falling to the lowest level in nine years (Deloitte, 1), the escalating cost of bringing medicines to market means that the biopharma R&D process must be examined in detail. One important factor is the development and validation of immunoassays that can deliver high quality data efficiently and in a timely manner. Speed and quality are intertwined, and while manual ELISA has been a major workhorse in biopharma R&D, automation is a key factor in speeding up the generation of high quality data with minimum hands-on time, minimum need for re-runs, and using readily validated assays that meet regulatory requirements.

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Topics: Assay Development, Regulated bioanalysis, Immunoassay


Jan 15, 2020 7:35:53 AM

Putting a new spin on immunoassays for cell and gene therapy – Part 2

Careful platform choice generates data with higher quality to support DOE

 

Putting a new spin on immunoassays for cell and gene therapy – Part 2Harnessing the power of cell and gene therapy involves a large range of analytical methods that can deliver robust results to support rapid data driven decision-making. One assay development team has used immunoassays to track a transgene IgG product. Their choice of immunoassay platform enabled them to generate high quality data that supported Design of Experiments to quickly optimize cell culture.

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Topics: Assay Development, Gene therapy, Gyrolab system


Sep 19, 2017 1:38:12 PM

The extreme reliability of Gyrolab assays

Singlicate Gyrolab immunoassays prove their worth (again)

bulls eye.pngIn 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.

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Topics: Assay Development, Pharmacokinetics


Jul 24, 2017 9:00:00 AM

Ligand binding assays for regulated bioanalysis

Guidance with immunoassays from initial assay design to final validation

REGULATORY.pngThe 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).

 

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Topics: Assay Development, Pharmacokinetics, Toxicokinetics, Regulated bioanalysis


May 15, 2017 2:22:17 PM

How to get it right the first time

The extreme reliability of Gyrolab assays

bulls eye.png

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.

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Topics: Assay Development, Pharmacokinetics


Apr 12, 2017 1:44:56 PM

Peptide fusion prolongs activity of eye disease drug

Immunoassays support research by coping with a difficult matrix

eye.pngA 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.

 

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Topics: Assay Development, Pharmacokinetics, Toxicokinetics, Regulated bioanalysis


Mar 28, 2017 1:10:37 PM

An immunoassay platform fit for regulated bioanalysis

Gyrolab xP workstation generates high quality data faster

REGULATORY.pngAs 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.

 

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Topics: Assay Development, Pharmacokinetics, Toxicokinetics, Regulated bioanalysis


Oct 20, 2016 9:18:27 AM

Quickly find the sweet spot in immunoassays

How Design of Experiments (DOE) boosts productivity

 

Changing_one_factor_at_a_time_may_easily_miss_the_optimum.pngBioanalytical 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.

 

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Topics: Assay Development


Dec 3, 2014 3:24:00 PM

High-performance immunoassays demand precision reagents

Anti-idiotypic antibodies home in on the true target

keyImmunoassays are only as good as the reagents they build on. Following up on the post ‘Success in the balancing act of ADA analysis‘, we found two new articles that clearly show how fine-tuned antibody reagents can support high performance immunoassays.

 

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Topics: Assay Development, ADA


Sep 15, 2014 3:47:00 PM

Success in the balancing act of ADA analysis

Why NovImmune moved from ELISA to Gyrolab xP workstation

ADA-in-the-balance_Anti-Drug Antibodies (ADA) can decrease drug half-life, reduce drug efficacy and even cause serious adverse reactions. Measuring ADA is therefore a key safety concern, but the immunoassays used to do this are complicated by the presence of drug and target in samples, which may severely reduce assay selectivity. This demands immunogenicity assays that are a balancing act between sufficient sensitivity, drug tolerance, and resistance to target interference.

 

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Topics: Assay Development, ADA