The following is a comprehensive list of our products. If you’re ready to place your order or have any questions, please visit the order placement page.
| Instrument | Contents/Description | Product No. |
| Gyrolab xPand | Includes Gyrolab xPand, Gyrolab software programs (Gyrolab Control, Gyrolab Evaluator and Gyrolab Manager), Gyrolab software modules (Gyrolab Viewer, Gyrolab ADA, Gyrolab Affinity, Gyrolab LIMS Interface, and Gyrolab Control Report), wash bottles and tubings, and start-up kit for sample handling (microplates (25), microplate foils (50), microplate foil adapter (1)). Twelve months warranty. Excludes cost for external PC and installation. | P0020520 |
| Gyrolab xPlore | Includes Gyrolab xPlore, Gyrolab Manager, Gyrolab Control and Gyrolab Evaluator, software licenses for 4 users, wash bottles and tubings, USB-stick 1 GB, start-up kit for sample handling (microplates (25), microplate foils (50), microplate foil adapter (1)), User Manuals (Gyrolab Instrument- , User- and Quick- Guides). 12 months warranty. Excludes cost for installation. | P0020300 |
| Gyrolab xP | Includes Gyrolab xP workstation, Gyrolab Manager, Gyrolab Control and Gyrolab Evaluator, software licenses for 4 users, degasser, wash bottles and tubings, USB-stick 1 GB, start-up kit for sample handling (microplates (25), microplate foils (50), microplate foil adapter (1)), User Manuals (Gyrolab Instrument- , User- and Quick- Guides). 12 months warranty. Excludes cost for installation. | P0004943 |
| CDs and Consumables | Contents/Description | Product No. |
| Gyrolab Bioaffy 1000* | 1 Gyrolab Bioaffy CD microlaboratory, 1000 nL sample volume, 96 microstructures. | P0004253 |
| Gyrolab Bioaffy 200* | 1 Gyrolab Bioaffy CD microlaboratory, 200 nL sample volume, 112 microstructures. | P0004180 |
| Gyrolab Bioaffy 20 HC* | 1 Gyrolab Bioaffy CD microlaboratory, 20 nL sample volume,112 microstructures. | P0004424 |
| Gyrolab Mixing CD 96 | 1 Gyrolab Mixing CD 96, 200 nL sample volume, 96 microstructures. Requires Gyrolab Control SW v. 7.2 | P0020455 |
| Rexxip A | 25 mL, 1 x standard formulation. Buffer of choice unless analytes are positively charged or hydrophobic or if heterophilic antibodies are present in the sample. | P0004820 |
| Rexxip A-max | 25 mL, 2 x standard formulation. Buffer of choice unless analytes are positively charged or hydrophobic or if heterophilic antibodies are present in the sample. | P0004821 |
| Rexxip AN | 25 mL, 1 x standard formulation, increased ionic strength. For positively-charged analytes. | P0004994 |
| Rexxip AN-max | 25 mL, 2 x standard formulation, increased ionic strength. For positively-charged analytes. | P0004995 |
| Rexxip H | 25 mL, 1 x standard formulation, agents to neutralize heterophilic antibodies. For samples containing heterophilic antibodies (e.g. human or cyno samples) and where the assay format (Ab/Ab) could cause false positives. | P0004822 |
| Rexxip H-max | 25 mL, 2 x standard formulation, agents to neutralize heterophilic antibodies. For samples containing heterophilic antibodies (e.g. human or cyno samples) and where the assay format (Ab/Ab) could cause false positives. | P0004823 |
| Rexxip HN | 25 mL, 1 x standard formulation, agents to neutralize heterophilic antibodies, increased ionic strength. For positively-charged analytes. | P0004996 |
| Rexxip HN-max | 25 mL, 2 x standard formulation, agents to neutralize heterophilic antibodies, increased ionic strength. For positively-charged analytes. | P0004997 |
| Rexxip HX | 25 mL, 1 x standard formulation 3, agents to neutralize heterophilic antibodies, suitable for human GLP-1 with potential for use with other negatively-charged analytes | P0020033 |
| Rexxip HX-max | 25 mL, 2 x standard formulation 3, agents to neutralize heterophilic antibodies, suitable for human GLP-1 with potential for use with other negatively-charged analytes | P0020034 |
| Rexxip CCS | 25 mL, 1 x standard formulation 2. Option for cell culture sample with high protein content, e.g. bioprocess samples. | P0004824 |
| Rexxip F | 10 mL, 1 x standard formulation, detergent A. For dilution of detection reagent and suitable for hydrophobic analytes. | P0004825 |
| Rexxip ADA | 25 mL, 1 x standard formulation 4, detergent A. For dilution of samples and controls when using Gyrolab Mixing CD. | P0020027 |
| * Orders can be placed for up to 500 CDs from a single batch. Please contact your local representative for details. | ||
| Kits | Contents/Description | Product No. |
| Gyrolab Protein A Kit - for MabSelect SuRe Ligand | Includes Gyrolab Protein A kit Reagents, one (1) Gyrolab Mixing CDs, three (3) PCR plates 96, three (3) Microplate foils and one (1) Gyrolab Wash Buffer pH 11. | P0020456 |
| Gyrolab huIgG Standard (IgG1) | Standard containing intact IgG1: 50 µl at 4 mg/mL | P0020379 |
| Gyrolab huIgG Kit – Low Titer | Includes enough reagents for 96 datapoints: 1x reagent kit, 1x Bioaffy 1000 HC CD, 3x PCR plate 96, 3x microplate foil, 1x Gyrolab Wash Buffer pH 11 | P0020381 |
| Gyrolab huIgG Kit – High Titer | Includes enough reagents for 112 datapoints: 1x reagent kit, 1x Bioaffy 20 HC CD, 3x PCR plate 96, 3x microplate foil, 1x Gyrolab Wash Buffer pH 11 | P0020382 |
| Gyrolab Generic PK Kit | Quantifies human IgG (intact) in several species of preclinical animal models, including cynomolgus monkey. The kit contains all necessary reagents including a Bioaffy 1000 HC CD to perform 96 datapoints |
P0020499 |
| Gyrolab Generic TK Kit | Contains all reagents including a Bioaffy 20 HC CD to perform 112 datapoints | P0020500 |
| Gyrolab CHO-HCP E3G Kit | Contains all necessary reagents to perform 96 datapoints and includes 1x reagent kit, 1x Bioaffy 1000 HC CD, 3x PCR plate 96, 3x microplate foil, 1x Gyrolab Wash Buffer pH 11. | P0020605 |
| Gyrolab CHO-HCP Kit 1 | Includes all necessary reagents to perform 96 datapoints: 1x reagent kit, 1x Bioaffy 1000 HC CD, 3x PCR plate 96, 3x microplate foil, 1x Gyrolab Wash Buffer pH 11. | P0020246 |
| Gyrolab CHO-HCP E3G Kit | Gyrolab CHO-HCP E3G Kit contains all necessary reagents to perform 96 datapoints and includes 1x reagent kit, 1x Bioaffy 1000 HC CD, 3x PCR plate 96, 3x microplate foil, 1x Gyrolab Wash Buffer pH 11. | P0020605 |
| Gyrolab E. coli HCP Kit | The kit contains all necessary reagents to perform 96 datapoints and includes one (1) Reagent kit, one (1) Bioaffy 1000 HC CD, three (3) PCR plates 96, three (3) Microplate foils and one (1) Gyrolab Wash Buffer pH 11. | P0020625 |
| Gyrolab p24 Kit | For lentivirus titer determination. The kit contains enough reagents and consumables to generate 96 datapoints. | P0020659 |
| Gyrolab AAVX Titer Kit | Gyrolab AAVX Titer Kit is designed for determination AAV (adeno-associated virus) viral vector titers in process development and manufacturing. The kit contains reagents and consumables, including CD, to generate 96 data points. | P0020695 |
| Gyrolab Bioaffy 1000 HC Assay Toolbox | Gyrolab Bioaffy 1000 HC Assay Toolbox includes CD, buffers and consumable to support development of process specific assays on Gyrolab open platform | P0020667 |
| Accsessories | Contents/Description | Product No. |
| Gyrolab Wash Buffer pH 11 | Biodegradable high-pH washing buffer. Package of 10x10 grams. 10 grams is required for 1 liter of needle wash buffer. | P0020096 |
| PCR Plate 96 | Pack of 25. To hold samples and reagents for processing within a Gyrolab workstation. | P0004861 |
| Microplate foil | Pack of 50. For sealing of microplates. | P0003313 |
| Microplate foil adapter | One (1) adapter for transfer of microplate foil to microplates. | P0003697 |
| Gyrolab User Licenses | Grants an unlimited number of Gyrolab software users. | P0004955 |
| Software modules | Contents/Description | Product No. |
| Gyrolab Viewer | Provides access to binding profiles of each data point directly from within Gyrolab Evaluator. Software module compatible with Gyrolab Control v 5.3 or higher and Gyrolab Evaluator v 3.2 or higher. Includes Instruction For Use and software licence for one instrument. | P0020028 |
| Gyrolab Viewer, 2 months time limited license |
Compatible with Gyrolab Control v 5.3 or higher. No training or technical support is included. | P0020070 |
| Gyrolab ADA Software | Enables analysis of anti-drug antibodies using Gyrolab ADA CDs. Supports ADA assay workflow through development and validation to screening and confirmatory analysis. Software module is compatible with Gyrolab Control v 5.4 or higher and Gyrolab Evaluator v 3.3 or higher. Includes Instruction For Use, software licence for one instrument, Gyrolab ADA assay protocol, instrument re-validation by Gyros-certified service engineer and one day training by Gyros-certified application specialist. | P0020025 |
| Gyrolab ADA Software, 2 months time limited license |
Compatible with Gyrolab Control v 5.4 and Gyrolab Evaluator v 3.3 or higher. No training or technical support is included. | P0020069 |
| Gyrolab Affinity Software | Enables Affinity software module from Gyrolab Evaluator. Software module is compatible with Gyrolab Control v 7.1 or higher and Gyrolab Evaluator v 3.4 or higher. Includes software license for one instrument, and one hour remote training by Gyros-certified application specialist. | P0020413 |
| Gyrolab LIMS Interface | Integrates Gyrolab workstation into a LIMS workflow. Software module compatible with Gyrolab Control v 5.2 or higher. Includes Instruction For Use, software licence for one instrument and support to cover the LIMS connection. | P0005028 |
| Gyrolab LIMS Interface, 2 months time limited license | Compatible with Gyrolab Control v 5.3 or higher. No training or technical support is included. | P0020068 |
| Gyrolab Control Report | Enables automatic generation of 21 CFR Part 11 compliant, non-editable, raw data report after each run. Software module compatible with Gyrolab Control v 5.3 or higher. Includes Instruction For Use and software licence for one instrument. | P0020006 |
| Gyrolab Control Report, 2 months time limited license |
Compatible with Gyrolab Control v 5.3 or higher. No training or technical support is included. | P0020071 |
| Performance and validation support |
Contents/Description | Product No. |
| Gyrolab Functionality Check Kit | A confirmatory test of instrument performance compatible with Gyrolab Control v 5.2 and higher. Includes Functionality Check CD (1), reagent (1500 μL), wash buffer (1500 μL), microplates and foils (2 of each), instruction for use (1). The kit is designed for one time use with the ability to repeat the check in the event that the the first check does not pass following a trouble shooting procedure. | P0005002 |
| IQ/OQ validation support and PQ guidance | Documented collection of procedures and test protocols for on-site installation, operational and guidance for performance qualification. Gyros-certified engineer performs IQ/OQ over approximately 3-4 days. Includes documented procedures on how to perform PQ. | P0003807 |
| Training and Application Support |
Contents/Description | Product No. |
| Basic Training Course | Introductory course. Excludes costs for travel and accommodation for Gyros-certified Application Specialist. Approximately 2.5 days for up to 3 attendees at user site or a Gyros facility. | P0004417 |
| Advanced Training Course | Advanced course for user holding a certificate from the Basic Training course. Excludes costs for travel and accommodation for Gyros-certified Application Specialist. Approximately 2.5 days for up to 3 attendees at user site or a Gyros facility. | P0004525 |
| Gyrolab Affinity Training | One day training by Gyros-certified application specialist at user site or a Gyros facility. Excludes costs for travel and accommodation for Gyros-certified application specialist. Maximum 3 participants. | P0020415 |
| Gyrolab ADA Training | Training by Gyros-certified application specialist at user site or a Gyros facility. This product is included in the purchase of Gyrolab ADA Software but can be offered as a separate training as well. Duration is 2 days of which half is classroom training and the other half is hands-on training in the laboratory. Excludes costs for travel and accommodation for Gyros-certified application specialist. Maximum 3 participants. | P0020043 |
| Field Application Specialist Support |
Gyros-certified Application Specialist to assist with assay development or other issues related to running immunoassays on a Gyrolab workstation. Time and costs determined per project. | P0004526 |
| Service contract (1 year) |
Contents/Description | Product No. |
| GOLD PLUS Service contract, Gyrolab xPand | Costs covered: spare parts and travel, labor & lodging costs for on-site repair visits. Routine hardware/software updates. Phone or email support for instrument networking. Software upgrades installed during PM or other scheduled service visit. Instrument revalidation – performed after software or hardware updates and upgrades or instrument relocation. Services and response times: Bi-annual on-site preventive maintenance (PM) visits, includes travel, lodging and labor costs. Service call/email response time within 8 working hours. On-site service visit within 2 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. | P0020524 |
| GOLD Service contract, Gyrolab xPand | Costs covered: spare parts and travel, labor & lodging costs for on-site repair visits. Routine hardware/software updates. Phone or email support for instrument networking free of charge up to 8 h. Services and response times: Annual on-site preventive maintenance (PM) visit, includes travel, lodging and labor costs. Service call/email response time within 8 working hours. On-site service visit within 3 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. | P0020525 |
| SILVER Service contract, Gyrolab xPand | Costs covered: 10% discount on spare parts. Routine hardware/software updates. Phone or email support for instrument networking free of charge up to 4 h. Services and response times: Annual on-site preventive maintenance (PM) visit, includes travel, lodging and labor costs. Service call/email response time within 12 working hours. On-site service visit within 4 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. | P0020526 |
| GOLD PLUS Service contract, Gyrolab xP | Costs covered: spare parts, on-site repairs, travel, labor, lodging costs for non-PM service visit. Routine hardware/software updates. Phone or email support for instrument networking. Software upgrades installed during PM or other scheduled service visit. Instrument revalidation – performed after software or hardware updates and upgrades or instrument relocation. Services and response times: Bi-annual on-site preventive maintenance (PM) visits, includes travel, lodging and labor costs. Service call/email response time within 8 working hours. On-site service visit within 2 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. |
P0020004 |
| GOLD Service contract, Gyrolab xP | Costs covered: spare parts, on-site repairs, travel, labor, lodging costs for non-PM service visit. Routine hardware/software updates. Phone or email support for instrument networking free of charge up to 8 h. Services and response times: Annual on-site preventive maintenance (PM) visit, includes travel, lodging and labor costs. Service call/email response time within 8 working hours. On-site service visit within 3 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. |
P0020003 |
| SILVER Service contract, Gyrolab xP | Costs covered: 10% discount on spare parts. Routine hardware/software updates. Phone or email support for instrument networking free of charge up to 4 h. Services and response times: Annual on-site preventive maintenance (PM) visit, includes travel, lodging and labor costs. Service call/email response time within 12 working hours. On site service visit within 4 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. | P0020002 |
| GOLD Service contract, Gyrolab xPlore | Costs covered: spare parts, on-site repairs, travel, labor, lodging costs for non-PM service visit. Routine hardware/software updates. Phone or email support for instrument networking free of charge up to 8 h. Services and response times: Annual on-site preventive maintenance (PM) visit, includes travel, lodging and labor costs. Service call/email response time within 8 working hours. On-site service visit within 3 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. |
P0020307 |
| SILVER Service contract, Gyrolab xPlore | Costs covered: 10% discount on spare parts. Routine hardware/software updates. Phone or email support for instrument networking free of charge up to 4 h. Services and response times: Annual on-site preventive maintenance (PM) visit, includes travel, lodging and labor costs. Service call/email response time within 12 working hours. On site service visit within 4 working days after diagnosis of instrument failure. Phone or email support for fast troubleshooting. | P0020308 |
|
Purchase of a Used Gyrolab Instrument: Use of a Gyrolab instrument purchased from any party other than Gyros Protein Technologies will constitute an actionable copyright infringement for which Gyros Protein Technologies will pursue all legal remedies available. If a purchaser desires to make use of a second-hand Gyrolab instrument without legal exposure, the purchaser must first obtain a valid Gyrolab software license from Gyros Protein Technologies. Please contact your local Gyros Protein Technologies representative for such a license. Please note that software licenses are not available for all Gyrolab instruments. |
||
The recent outbreak of the novel coronavirus disease (COVID-19) has resulted in a worldwide pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Efforts to slow the spread of the virus and to develop vaccines and treatments require SARS-CoV-2 antibody testing. To meet this need, we have developed a Gyrolab immunoassay for qualitative detection of total antibodies generated against the receptor binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in human serum samples.
Protein biomarkers are utilized in all phases of the drug development process from discovery to clinical studies to evaluate a drug’s effectiveness or potential toxicity. Immunoassays remain the most selective, specific, and sensitive method to determine protein biomarker levels. However, the development of these assays can be challenging due to the high sensitivity required and serum matrix interference.
We have developed immunoassays with supporting data to provide a foundation to speed up your biomarker immunoassay development.
As biologic drugs come off-patent and biosimilar versions become available it is vital to ensure that the biosimilars have similar PK, efficacy, and safety profiles to their branded equivalents. The equivalence of biosimilars is a point of concern since the tight relationship between structure and function of biologics means that pharmacology can be affected by even minor changes during the manufacturing process. We have therefore developed a set of robust Gyrolab PK assay protocols to support the development of biosimilars from nonclinical to human clinical studies.
A key requirement in biopharmaceutical manufacturing is the development of a robust, sensitive, and high-quality bioanalytical method for the detection of impurities that inevitably carry over from the production process. These impurities can originate from the culture media or additives, from the purification process such as protein A leaching from a purification column, or from the host cells. The presence of host cell proteins (HCPs) is of particular concern, as these contaminants pose an immunogenicity reaction risk to the patients.
To assist with the development of immunoassays for bioprocess impurity analysis, we have developed robust assay protocols to determine process-related impurities in bioprocessing samples.
Measuring anti-drug antibody (ADA) levels is an essential part of developing new biologics. The clinical implication of the presence of anti-drug-antibodies in treated patients may include allergic reactions, immune complex toxicity, autoimmune reactions and reduction of efficacy.
Recently regulatory agencies have lowered the sensitivity requirement for ADA detection, from 250-500 ng/mL to 100 ng/mL. To reach such sensitivity levels without affecting the assay drug tolerance, sample pre-treatment steps may be necessary. Gyrolab ADA Solution streamlines ADA assay workflows and automates acid dissociation steps to improve sensitivity and drug tolerance of ADA assays while reducing variability and saving time. ADA assays can also be developed using overnight incubation protocols to dissociate the drug-ADA complexes prior to determination of ADA levels in clinical samples using Gyrolab Bioaffy 200 or 1000 CD.
To meet the needs of immunogenicity evaluation during biotherapeutic development, we have developed Gyrolab protocols to determine ADAs in clinical or preclinical samples that have been treated with marketed biopharmaceuticals.
