Gyrolab CDs Product Information Sheet D0012493/D Rapid assay development – Ready to use CDs Save time and minimize sample consumption – Integrated, nanoliter-scale assay workflows Full flexibility in assay design High quality results in less than 1 hour Immunoassays from discovery to the clinic More information from less sample The Gyrolab™ Bioaffy CD range offers an open, nanoliter-scale immunoassay. A broad dynamic range ensures suitability for pharmacokinetic/pharmacodynamic studies and biomarker monitoring as well as product quantification and impurity testing during bioprocess development and production. Analytes measured from picogram to milligram The broad dynamic range minimizes the need for dilutions and repeats, providing a scaleable assay format that does not need to be re-developed. Effects on sample integrity are minimized by lowering the minimum required dilution (MRD). Full pharmacokinetic profiles from three individual mice following i.v. administration of a therapeutic antibody (Bioaffy 200). Data courtesy of Astra Zeneca. The broad dynamic range is well suited when testing for impurities such as HCPs or protein A. 0 500 300 400 200 100 Time (h) 3 mg/kg i.v. Mouse 1 Mouse 2 Mouse 3 Pharmacokinetics: one mouse/onePK 100000 1000 1000 Rat lgG1 (ng/ml) 1 10 1000 10000 100 Concentration (ng/mL) Impurity testing: HCP quantification 100 10 1 Response Bioaffy 200 Bioaffy 20HC
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Gyrolab CDs
Product Information Sheet D0012493/D
Rapid assay development
– Ready to use CDs
Save time and minimize sample consumption
– Integrated, nanoliter-scale assay workflows
Full flexibility in assay design
High quality results in less than 1 hour
Immunoassays from discovery to the clinic
More information from less sample
The Gyrolab™ Bioaffy CD range offers an open, nanoliter-scale immunoassay. A broad dynamic range ensures suitability for pharmacokinetic/pharmacodynamic studies and biomarker monitoring as well as product quantification and impurity testing during bioprocess development and production.
Analytes measured from picogram to milligram
The broad dynamic range minimizes the need for dilutions and repeats, providing a scaleable assay format that does not need to be re-developed. Effects on sample integrity are minimized by lowering the minimum required dilution (MRD).
Full pharmacokinetic profiles from three individual micefollowing i.v. administration of a therapeutic antibody (Bioaffy 200).Data courtesy of Astra Zeneca.
The broad dynamic range is well suited when testing for impurities such as HCPs or protein A.
0 500300 400200100
Time (h)
3 mg/kg i.v.
Mouse 1Mouse 2Mouse 3
Pharmacokinetics: one mouse/onePK100000
1000
1000
Rat
lgG
1 (n
g/m
l)
1 10 1000 10000100
Concentration (ng/mL)
Impurity testing: HCP quantification
100
10
1
Resp
onse
Bioaffy 200Bioaffy 20HC
2 D0012493/D
Gyrolab Bioaffy CD
QC Samples Mean(μg/L)
Inter-CD CV (%)*
Relative error (%)
Total error (%)
500 504.21 7.7 0.8 8.6
375 351.98 7.0 -6.1 13.1
250 242.79 3.7 -11.7 15.4
5 4.84 4.5 -3.1 7.6
2 1.94 6.9 -2.8 9.7
* Inter-CD CV% calculated using ANOVA.
Intra-CD Gyrolab Bioaffy 200: in-house validation using a clinical PK assay of a commercially available biotherapeutic recombinant antibody – 5 QC samples in quadruplicate from a single run.
Integrated, nanoliter-scale workflows
Samples are processed simultaneously in parallel, with every step controlled through an automated method. This illustration shows key steps in a sandwich assay and examples of assay formats.
Save time and reduce consumption
Working at nanoliter scale reduces overall processing time and minimizes consumption of sample and reagent. Precise control over assay workflow ensures reproducibility. Faster reactions eliminate lengthy incubation steps found in conventional assay formats.
Single and Gyroplex assays
Users have the option of running single or Gyroplex™ (multiple analyte) assays. Gyroplex assays enable, for example, up to five biomarkers to be monitored in a single run using Bioaffy 1000 CDs. Each CD can include a standard curve and duplicate samples for a specific biomarker. As little as 50 μL of sample (10 μL per duplicate) is consumed.
Bind capture reagent to affinity column
Prepare samples in Rexxip buffer
Design run in Gyrolab Control.
Evaluate data in Gyrolab Evaluator
Load sample
Load detection reagent
Read fluorescence
Generic PKSandwich
Indirect antibody Bridging assays
One microstructure – one data point – no cross-talk.
Common channel for assay reagents
Volume definition area (200 nL)
Affinity-capture column (15 nL)
Individual inlet for sample addition
Overflow channel for excess liquid – ensures reproducible filling of sample
Volume definition chamber – accurate sample volumes (20, 200 or 1000 nL)
Spiked human serum, serial dilutions in Rexxip A 3 CD batches: 5 standard curves per CD, one run1 CD: x2 standards, 4 blanks, 5 x 4 QC samples
1 10 100 1000
1
10
100
Reproducibility and precision
Low inter-CD variation of assay on Gyrolab Bioaffy 200: in-house validation using a clinical PK assay of a commercially available biotherapeutic recombinant antibody.
3D0012493/D
Gyrolab Mixing CD
ADA controls 1 2 3 4
Concentration (ng/mL) 1000 200 100 50
Intra-CD CV (%) Run 1 3.7 5.6 10.3 15.1
Intra-CD CV (%) Run 2 4.7 5.3 5.2 17.4
Intra-CD CV (%) Run 3 6.2 22.1 10.0 2.8
Inter-CD CV (5) 5.0 19.1 11.7 21.2
The data demonstrates high precision within and between runs for quality control samples in 10% human matrix.
Samples loaded into mixing chambers automatically
Prepare samples in Rexxip ADA
Evaluate data in Gyrolab
ADA Software
Acidic buffer added – mixed and incubated
Drug:ADA complexes dissociate
ADA complexed with free drug
Neutralization buffer and labeled reagents added - mixed and incubated
Automated sample pretreatment and immunoassay at an integrated, nanoliter-scale
The illustration shows key steps in a bridging homogeneous assay format used to measure Anti-Drug Antibodies (ADA). Gyrolab Mixing CD enables 48 samples to be processed simultaneously in parallel, with every step controlled through an automated method.
The detection of ADAs is a prime example of integrating sample pretreatment into the nanoliter-scale immunoassay workflow of Gyrolab Mixing CD. Addition of a mixing chamber allows for greater flexibility in assay workflows requiring additional incubations for equilibration, acid treatment or enzymatic reactions to occur. These additional assay steps typically add complexity and time to existing assays, while the Gyrolab Mixing CD not only integrates sample pretreatment, but also shortens assay and incubation times with its nanoliter-scale workflows.
Compatible with many matrices
The microfluidic, flow-through format, coupled with short incubation times achieved by working at nanoliter scale, minimizes the risk of matrix interference.
Gyrolab CDs can be used with matrices such as human or animal serum, plasma, sputum, cerebrospinal fluid and cell culture supernatant.
Inlet for wash solutions or capture reagents for specific assay formats
Inlet for samples/reagents/buffers
Volume definition (200 nL)
Volume definition (200 nL)
Affinity-capture column (15 nL) packed with streptavidin-coated Dynospheres™
Consistent volume delivery and flow control -hydrophobic barriers stop liquid flow
Overflow channels for excess liquid and reproducible volume definition
Mixing chamber for incubation steps
One microstructure – one data point – no cross-talk.
PK assay in 5% and 50% human serum shows minimal matrix interference.
Resp
onse
Concentration (ng/mL)1 10 100 1000
1
10
100 5% serum50% serum
Reproducibility and precision
Parallel processing with precise control of mixing and incubation times ensures consistent assay performance.
Shelf life (unopened package): Minimum 12 months after delivery.
Storage (opened package)*: CDs must be used within one week of opening. Return partially used CDs to original CD box and pouch.
Re-seal. Store dark, dry and at room temperature.* Partially-used CDs can be run again. To guarantee optimal performance, Gyros recommends using a new CD for each run.
Chemical compatibility of Gyrolab CDs
Streptavidin-coated particles and surfaces within CD microstructures stable in buffers pH 2-10.
Compatible with the following solutions: 0.2% Tween 20, 40% methanol, 30% dimethyl sulfoxide (DMSO), 30% 2-propanol, 0.01% Triton X-100, 0.1% SDS.
Bioaffy CD selection and specifications
Several parameters influence the choice of Bioaffy CD such as the required dynamic range, analyte concentration, quality of reagents and assay format. For most applications, the Gyrolab Bioaffy 200 CD is used as a starting point.
Ordering information
Product number Product name
P0004424 Bioaffy 20 HC
P0004180 Bioaffy 200
P0004253 Bioaffy 1000
P0020026 Gyrolab Mixing CD
Sample volume( nL) Microstructures Lower Limit of Quantification (LLOQ)
Column packing
Bioaffy 1000 1000 96 Up to 5 times lower LLOQ than Bioaffy 200
