Immunogenicity

Gyrolab^® delivers accurate results in a fraction of the time and with fewer manual steps.

Assessment of anti-drug antibodies (ADAs) as well as neutralizing antibodies (NAbs) is a fundamental part of immunogenicity testing. ADA immunoassays for biotherapeutics are extremely complex and require lengthy protocols to maximize drug tolerance, minimize drug interference and establish equilibrium, using methods such as overnight incubations and acid sample pretreatment.

Gyrolab feature/benefits for ADA immunoassays:

Reduces hands-on time
Automated sample pretreatment and assay workflows
Shorten overall run times
Results can be obtained in as little as one hour
Saves precious reagents and samples
5 µL sample is sufficient for duplicates
Streamlines workflows from assay development through screening to confirmation:
Gyrolab ADA protocol and dedicated Gyrolab ADA analysis software

Gyrolab ADA solution provides nanoliter-scale methods for ADA detection using automated acid dissociation or offline incubation. Working at nanoliter-scale reduces processing times and minimizes sample/reagent consumption. Dedicated Gyrolab ADA software, designed for 21 CFR Part 11 compliance, facilitates data analysis for either screening or confirmatory results. Gyrolab systems produce assays exhibiting high drug tolerance coupled with high sensitivity and consistent performance providing high quality data.

Gyrolab ADA Software

Assessment of neutralizing antibodies (NAb)

NAb detection is an important aspect of immunogenicity assessment, requiring sensitive and reliable methods reflective of the therapeutic mechanism of action (MoA). Two types of Nab assays are mainly used; a non-cell-based competitive ligand binding assay (e.g. Gyrolab) or a cell-based bioassay.

With iLite® Assay Ready Cells, presence of neutralizing antibodies can be assessed in both screening and quantitative format.

Gyrolab Systems

Gyrolab technology reduces manual labor, assay development time, time to result and material consumption -and it improves workflow efficiency.

[Brochure]

Gyrolab ADA solutions

Gyrolab ADA solution provides nanoliter-scale methods for ADA detection using automated acid dissociation or offline incubation. Dedicated software facilitates data analysis for either screening or confirmatory results.

[Product information sheet]

Evaluation of Gyrolab™ and Meso-Scale Discovery platforms in the development of a clinical immunogenicity assay

J Collet, A Moreau et. al. NovImmune SA, Geneva, Switzerland

[Poster]

Sabrina Lory Developing fit-for-purpose immunoassays

Recorded Seminar: Sabrina Lory, Head of the Bioanalytical Assay Laboratory, NovImmune, presents ‘Developing fit for purpose assays using the Gyrolab platform'.

[Seminar]

Assessing the immunogenicity of biopharmaceuticals

Recorded Webinar: Immunogenicity of therapeutic biopharmaceuticals can impact both the efficacy and the safety of the product. Assessment of anti-drug antibodies (ADAs) as well as neutralizing antibodies (NAbs) is a fundamental part of immunogenicity testing. Presenters: Cecilia Bill, Gyros Protein Technologies and Frida Pauly, Euro Diagnostica.

[Webinar]

Rapid Reagent Screening and Characterization using Automated Nanoliter-scale Immunoassays

Recorded Webinar: Gyrolab is a reliable immunoassay platform that streamlines reagent selection and characterization during method development for biotherapeutics. Presenters: Frank Zambito, Research Scientist I, Bioanalytical Sciences, Bristol-Myers Squibb and Shawn Fernando, Senior Principal Researcher, Morphotek, Inc.

[Webinar]

Developing and Validating a Gyrolab ADA Assay to address drug tolerance and small sample volume

Recorded Webinar: Presenter Katrina Olson, Senior Associate Scientist, Pfizer, Andover. In this recorded webinar, Katrina describes the development of a Gyrolab bridging ADA assay, and the challenges that were surmounted in the development process.

[Webinar]

Immunogenicity

Gyrolab® delivers accurate results in a fraction of the time and with fewer manual steps.

Gyrolab feature/benefits for ADA immunoassays:

Assessment of neutralizing antibodies (NAb)

+46 18 566 300

Gyrolab^® delivers accurate results in a fraction of the time and with fewer manual steps.