iLiteTM antibeta
- Introduction
- Applications
- Methodologies
- How Does The Assay Work?
- Key Advantages of iLiteTM antibeta
- How to Order
Introduction
iLiteTM antibeta is a gene reporter assay for the detection and quantification of neutralizing antibodies to IFN β.
Biopharmaceuticals (i.e. therapeutic proteins produced through recombinant DNA technologies) must be injected into patient tissues to achieve optimal efficacy. This route of administration almost always elicits an immune response.
These induced antibodies can alter pharmacokinetics, change bio-distribution, cause hypersensitivity reactions and immune complex disease, block therapeutic activity and, in some cases, have lethal side effects.
International regulatory bodies now recognize the need to characterize the potential immunogenicity of these drugs during the developmental studies and for post-approval patient monitoring programs. Current assays to detect and characterize these antibodies are complex, difficult to standardize and often unreliable.
Neutekbio's iLiteTM technology has been adapted to detect and quantify neutralizing antibodies (NAbs) in a robust, reliable, economic and easy to use format.
Applications
The iLiteTM antibeta Assay can be used for:
1. Screening for the presence of NAb.
2. Determination of the titre in NAb positive samples.
Suggested Methodologies
1. Screening of Samples for Presence of NAb to IFNβ - View Details
2. Determination of NAb Titre - View Details
The iLiteTM antibeta assay is a practical and useful tool for IFN post-approval patient monitoring research programs, which are now being emphasized by the healthcare regulatory agencies. Neutekbio’s iLiteTM technology can be easily adapted to high volume screening of samples as well being utilized to generate precise quantification of antibody titres using conventional calculation methodologies.
The presence of drug-specific antibodies and reliable assays for these molecules are of increasing importance to healthcare funding agencies and biopharmaceutical manufacturers keen to optimize long term therapeutic performance, maximize patient quality of life and minimize unnecessary consumption of resources.
The iLiteTM antibeta assay will also find significant applications in the biopharmaceutical industry during drug discovery, pre-clinical and clinical development studies of interferon and interferon-like drugs. In addition, because of the emphasis on quality manufacturing in meeting the highest industry standards in performance specifications and reliability, the iLiteTM technology can be employed in manufacturing process control and product release analyses.
Neutekbio’s iLiteTM antibeta is the first bioassay product designed for the measurement of NAbs to be manufactured under strict adherence to ISO13485 quality systems to be introduced into this growing market segment. Research studies with multiple sclerosis (MS) samples indicate that iLiteTM antibeta is a specific, highly sensitive assay for NAbs against IFN-β. The studies provide data that can be correlated with with more traditional methods, i.e. CPE assay.
View Clinical Data - Graph and Details »
This test is for research use only, and should not be used by physicians for diagnostic purposes. The product is intended as a clinical research tool.
How Does the Assay Work?
Neutekbio's iLiteTM antibeta is intended for use as an in-vitro test for the semi-quantitative determination of neutralizing antibodies to IFNß in serum, using luciferase generated bioluminescence.
Samples are sequentially diluted and pre-incubated with a known quantity of IFNβ. Following this pre-incubation, Human Type I interferon-sensitive cells are added to the wells and further incubated.
Upon addition of lysis reagent and substrate, the resultant bioluminescence intensity is measured. Light intensity is proportional to the amount of Type I IFN activity remaining in the well and from this it can be calculated the serum dilution that gives 1 LU, the endpoint of the assay.
View iLiteTM antibeta Assay Procedure Flowchart »
View Analysis of the Results »
Key Advantages of iLiteTM antibeta
- Next day results. Set up on Day 1 takes approximately an hour (includes 30 minute incubation step); this is followed by an 18 hour incubation step. On Day 2, bioluminescence, and therefore neutralizing antibody activity results are available following addition of lysis buffer and substrate.
- Increased sensitivity. In studies using research samples, iLiteTM antibeta appears to have increased sensitivity in the detection of weakly positive samples when compared to traditional methods. The assay has 100% accuracy when tested with NAb negative normal donors, giving no false positive results. In some cases, iLiteTM antibeta detected low titres of NAb in samples previously classified as negative by classical methods.
- Dual application of the assay. The iLiteTM antibeta can be used for both initial screening of samples, and a specific NAb titre of positive samples. For additional precision, the kit standard may be replaced by the commercially available IFNβ used by the researcher, thereby providing meaningful, drug specific results.
- No costly and continuous cell culture requirements. The iLiteTM antibeta Assay is ready when you are. Because of the use of Neutekbio's patented ''division arrested'' cell technology, the iLiteTM interferon sensitive cells are simply thawed as and when you need them and the assay is ready to go.
- No need for infectious virus standard preparations which are required by the current time consuming and less reliable tests, thus reducing biohazard risk within your laboratory.
- No more unacceptable intra-assay variability. All Neutekbio products are manufactured in a facility that operates to ISO13485 QUALITY SYSTEMS. The final product is subjected to rigorous quality systems testing, ensuring reproducibility and reliability. The kit contains all the required components in an easy to use format and is ready to use straight from the freezer.
- Ease of Use. Due to its simple format and ease of use, the iLiteTM assay is easily transferable to a CRO for clinical investigations, needing a lower level of technical expertise than other techniques available.
How to Order iLiteTM antibeta
To order iLiteTM antibeta, please go to our Order Page >>