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iLite® - A cell-based reporter gene system you can trust

iLite® Cell-Based Solutions

The iLite® cell-based solutions are based on the iLite technology, a cleverly engineered cell-based assay system with a dual reporter gene readout. They offer the ease of use and robustness of a Ligand Binding Assay and can be developed for virtually any pharmaceutical target and allows an easy, rapid and accurate test format for measurement and quantification of drug activity and immunogenicity. 

Cell-Based Assay & Reporter Gene Assays
What are they?

Cell based assays are defined as any assay that takes place within a living cell. Because this definition is so general, there are thousands of different cell based assays.

Reporter-gene assays are a specific kind of cell-based assay with an engineered system that incorporates a regulatory elements that control a given gene and that use an easily detectable readout like luciferase.

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Developing Cell-based Reporter Gene Assays
A complicated process

When developing a new cell-based assays, or keeping existing ones alive - there are many hurdles to overcome. Being able to create an assay with a reproducible readout, a high signal-to-noise ratio is challenging and cumbersome which is necessary to achieve sufficient selectivity (few false-positives) and sensitivity (few false negatives), plus high stability.

iLite Product Groups

Functional Bioassays
Fc Effector Activity Bioassays
     - ADCC Bioassays
     - ADCP Bioassays
     - Target Cells
T-Cell Activation Bioassays
Gene Therapy Solutions
Custom Cell-based Services

Assay Ready Cells - As easy as 1-2-3
Save time and money by not having to culture your own cells

The iLite®  cell-based solutions are supplied as cryopreserved assay ready cells, that are harvested and frozen at the same time, which means a higher reproducibility and overall superior performance compared to cells in culture can be obtained. Not the mention the time and cost you can reduce but not having to culture your cells!

1. Thaw

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Start by thawing your assay-ready cells. All cells were harvested and frozen at the same stage which ensures excellent reproducibility and performance. Save time and cost by not having to culture your cells.

2. Plate

iLite cell based reporter gene assays being applied with multipipette onto assay plate

Next, plate your cells and add your sample. The cells contain a secondary reporter gene that can be used as a powerful tool for normalizing results and to compensate for differences in cell numbers. This means that you can be confident that you get a target-specific signal.

3. Incubate & Read

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Finally, incubate and read your assay. The combination of excellent target specificity and a high signal-to-noise ratio ensures a biologically relevant functional assay.

iLite Product Groups

Explore our range of cell-based Functional Bioassays, ADCC system with Effector and Target cells engineered to work optimally together as well as our Gene Therapy solutions.  

Gene Therapy Solutions

We offer robust platforms suited for all phases of drug development, as well as extended experience and knowledge of cell-based solutions, We are currently developing cell-based assays for immunogenicity and potency testing and can also offer custom cell lines to assist in any gene therapy project.

Join us as we explore the Future of Gene Therapy

Gene Therapy

iLite® Fc Effector Activity Bioassays

The iLite Fc Effector Reporter Gene Bioassays Portfolio - a range of reporter gene cell lines and antigen-specific target cells that can be used in biologically relevant, MOA-reflective assays to measure the Fc effect of antibodies and other biologics that specifically bind and activates Fc receptors.

Greater than the sum of its parts

Fc Effector Activity Bioassays

Functional Bioassasys

Benefit from our off-the-shelf iLite® Assay Ready Cells

iLite® cell lines are available for a number of biopharmaceutical targets. They can be used for sensitive and specific measurement and quantification of drug potency, detection of neutralizing antibodies (NAbs) and assessment of immunogenicity.

iLite Cell lines

iLite® ADCP Bioassays

Learn more about of FcγRIIa/CD32 effector cell line - how it works, its applications, and performance data

Delivering optimal ADCP bioassays

ADCP Bioassays

Custom Cell-based Services

Cell-based solutions adapted to your needs

We custom cell-based services such as assay ready cell development from sponsor-provided cell lines or cells from other cell line providers, Master Cell Bank Development, and the opportunity of creating custom iLite cell lines for your target of choice.

Cell-based Services

iLite® ADCC Bioassays

The iLite ADCC product portfolio is based on a reporter gene system and offers a convenient and powerful way of measuring the efficacy of antibodies to elicit ADCC in vitro.

Delivering optimal ADCC bioassays

ADCC Bioassays

ILITE TECHNOLOGY: How it works

The iLite reporter gene system

When a ligand, e.g. your drug candidate, binds to its receptor on the iLite cell surface, a specific intracellular signaling pathway is activated. This triggers the transcription of a specific reporter gene construct coding for luciferase.

When a substrate is added, the luciferase generates light, and the amount of luciferase and thereby the amount and activity of the ligand can then be measured as light emission using a luminometer.
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Unique features of the iLite cells

By combining unique features such as a normalization readout and chimeric transcription factors with a highly flexible product format, the iLite technology can help you make the most of your bioassay.

Briefly, the chosen host cell is transfected with target specific genetic constructs and stable clones are produced that carries both a inducible (Target specific) reporter gene and a Constitutive (Normalization gene) as wells as constructs for expression of surface receptors and for engineered transcription factors. 
Read more about the iLite Technology

Watch the iLite Technology video

Find out how our cell-based solutions can help you in the assessment and development of new drugs.

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APPLICATION AREAS: How can the iLite® Cell-based Solutions help me?

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Cell-based assays is a versatile tool for the whole drug development process and there are many reason for conducting cell based assays.

As many of the biological drugs that exists, or are currently under development, have multiple functional domains that interact with several different molecules in order to function appropriately, different tests and validations of the function, efficiency and safety must be performed before the end product is released. 

In a regulatory setting, cell based assays are commonly used for cytotoxicity testing, to determine the biological activity (potency) of drug product and drug substance, to determine the mechanism of action (MOA), early stage proof of principal studies, and in immunogenicity studies to determine if antibodies produced by the patient are neutralizing the drug product.
Read more about Application Areas

“Generally FDA considers that bioassays are more reflective (than competitive ligand-binding assays) of the in vivo situation and are recommended” (Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins, issued by FDA, Dec 2009.)

“Ideally, the potency assay will represent the product's mechanism of action (i.e., relevant therapeutic activity or intended biological effect)” (Guidance for Industry: Potency for cellular and gene therapy products, issued by FDA, Jan 2011)

“For most biological products, the most appropriate neutralizing antibody assay is a bioassay which measures the neutralization of the bioactivity” (EMA Guidance on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, issued by EMA, 2012.)

KEY BENEFITS: Engineered for you

Assay Ready Format
Fast, easy and reproducible results

iLite cells are delivered as Assay Ready Cells, and stored at -80°C. There is no need for cell culturing and continuous maintenance of cells – just thaw and dilute before use in the assay.

Besides significant reductions in the amount of labor required and assay turnaround times, the Assay Ready Cell format also gives superior assay reproducibility in comparison to cells in culture, since all cells are cryopreserved at the same passage number.

Normalization Gene
Ideal for accurate normalization

A second reporter gene used as an internal control will compensate for differences in cell number – you no longer need to count the number of cells in each well.

In addition, it can be used to compensate for serum matrix effects, other complex matrices or if luciferase is sensitive to the compound you are analyzing.

Sensitivity and Specificity
Get a strong signal with minimal pathway crosstalk

The sensitivity of iLite cells is enhanced through up-regulation of key components, such as the receptor and certain signaling pathway proteins. The up-regulation of receptors also confers a higher specificity, and this is enhanced through the use of chimeric transcription factors and synthetic reporter gene promoters.

These elements are used as a lock and key to transcription of the reporter gene – only the chimeric transcription factor can bind to the synthetic promoter, and endogenous transcription factors are thereby unable to trigger expression of the reporter gene. In this way, pathway cross-talk can be effectively minimized.

Assay Precision
Benefit from great reproducibility and accuracy

The Assay Ready Format not only reduces the assay turnaround times and amount of labor required, but also reduces assay variability in comparison with cells in culture. Traditionally, cell-based assays are known for their high variability, with %CV often over 25%.

Robustness assays of iLite assays have shown that repeatability and intermediate precision are in the range of 4-11% CV, and sample accuracy between 92-107%. In other words, by using iLite Assay Ready Cells, you are getting the biological relevance of a cell-based assay with the ease of use and precision normally associated with a ligand binding assay.

 

BUSINESS MODELS: What formats do our cell-based solutions offer?

Our cell-based solutions is a versatile tool for applications extending across the whole drug development process and can be applied to many different drug targets.

As every project is different and every development process has its own hurdles to overcome, our custom cell-based development services enables us to offer versatile assay solutions to pharma, biotech and CRO customers, as well as to our partners within diagnostics, tailored to your specific needs. 

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Assay Ready Cell Service
for your cell line of choice

Our experience and knowhow of developing assay ready cells are now at your disposal. We develop assay ready cells from sponsor-provided cell lines or cells from other cell line.
Assay Ready Cells

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Master Cell Banking 
your proprietary iLite® MCB

We now offer cell-banking services for our iLite cell-lines – get your own proprietary master cell bank and benefit from a new level of traceability and sustainability.
Master Cell Banking

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iLite Custom Cell Line
for your target of choice

We can create a custom iLite cell line tailored to your needs. Get all the benefits of iLite cells, such as assay-ready cells and normalization capabilities for your target of choice
Custom Cell Lines

iLite® Cell-Based Portfolio

T-Cell Activation Bioassays

Assessment of CD3-induced T-cell activation

Fc Effector Activity Bioassays

Effector and Target cells engineered to work optimally together

ADCP Bioassays

FcγRIIa/CD32 effector cell line

ADCC Bioassays

FcγRIIIa/CD16 effector cell line

Target Cells

Engineered, homologous, and specific target cells that enable screening for antibody-induced effector functions

Functional Bioassays

Off-the-shelf Assay Ready Cells for a number of biopharmaceutical targets

Gene Therapy Solutions

Bringing the benefits of iLite® technology to gene therapy

Custom Cell-based Services

Custom Development – Cell-based solutions adapted to your needs