Gyrolab Spin Blog

Jul 11, 2018 9:00:00 AM

Does your antibody have the right affinity?

The value of affinity determination in assay development and throughout drug development

Affinity curve

The drive to lower drug dosage, improve healthcare and reduce costs has lead to the search for therapeutic antibodies with high target affinity. As a consequence, optimizing and monitoring the specificity and affinity of drug candidates to the target molecule has become critical in the development of therapeutic antibodies – from early screening of hybridomas or recombinant antibodies from phage display libraries, to affinity maturation and antibody engineering to improve the efficacy, safety and manufacturability of the final antibody drug product. Characterizing affinity is also important when selecting reagents for quantitative assays or assessing drug product activity in manufacturing release tests. The question is, how can high affinity be measured in the best possible way?

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Topics: Pharmacokinetics, Affinity, Affinity in solution, immunoassay

Apr 25, 2018 2:22:39 PM

How to overcome disease-specific matrix interference

Minimize incubation times with flow-through immunoassays

dropMatrix interference can be a major challenge in the development of immunoassays to study a number of disease states. Kathi Williams and her colleagues at Genentech Inc., USA, experienced considerable problems with matrix interference when developing an ELISA for Phase III studies of a humanized monoclonal antibody when a new patient group was introduced. The solution was to transfer the assay to the Gyrolab platform that, thanks to its flow-through technology helped minimizing matrix effects by reducing the incubation times with the capture reagent antibody.

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Topics: matrix, Pharmacokinetics, immunoassay, clinical trial, Phase III studies, ulcerative colitis, Crohn's disease

Mar 19, 2018 3:30:00 PM

Latest news from BPI West: Gyrolab xPand speeds up the implementation of QbD


Gyrolab_xPand_blog.pngThis 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.

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Topics: Gyrolab xPand

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

Mar 7, 2017 11:13:36 AM

Recorded affinity webinar available

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

johan-engstrom.pngDuring 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 KD’s and active concentrations of interactants. Johan also gave examples of determinations of picomolar affinities for several marketed TNFα antagonists.


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Topics: Affinity

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