Custom Assay Development & Innovation (CADI) Services: Discover the Possibilities

Reconfigured Analytes From Existing MILLIPLEX^® Multiplex Panels

Our Special Product Release (SPR) program allows you to combine analytes from up to three panels without completing a custom assay development request or creating a work plan. Instead, your local immunoassay specialist will submit your list of analytes for a feasibility review that leverages our knowledge base of pre-verified analyte/panel combinations.

If the combination is feasible, we combine off-the-shelf kit components from multiple existing MILLIPLEX^® panels to create the mix of analytes you need. High/low quality control (QC) range values are also available for an additional testing fee.

Custom Assay Development

We understand you do not always have the time or resources to develop your own custom assay for your protein(s) of interest. For any immunoassay requiring new analyte development or any reconfigured MILLIPLEX^® assays with more complex combinations (analytes from 4 or more existing panels), you will partner with your local sales specialist and a member of the CADI team to define the project scope. We then review the feasibility based on reagent availability for new analyte development and compatible sample dilution, matrix, sample preparation requirements, and known analyte cross-reactivity for new mixes of MILLIPLEX^® analytes/panels.

After the feasibility review, you receive a quote outlining the milestone-based approach we will take to generate a robust fit-for-purpose MILLIPLEX^®, ELISA, or SMC^® immunoassay that accurately and reliably quantifies your target biomarker(s) for you. At each milestone you will participate in data reviews, giving you the peace of mind that your project is on schedule and meeting specifications.

Ultimately we aspire to provide the quality and ease of use you expect from an immunoassay. To that end, we offer additional assay development options to take your program from discovery research to clinical trials:

• Different formats
  • Switch an existing MILLIPLEX^® antibody pair to the SMC^® platform when greater sensitivity is needed
  • Convert an existing MILLIPLEX^® assay from 96-well to 384-well or select a 384-well format for your custom assay
  • Choose a bead-based or a plate-based SMC^® custom assay format
• Custom reagents*
  • High/low QCs with range values
  • Premixed beads
  • Bead re-conjugation to resolve bead region conflicts
• Real sample testing during development
  • With client-provided samples, so we can test in-house throughout development
    
  • With test kits sent to customer for their evaluation

*Additional fees may apply.

Additional Biomarker Development and Detection Capabilities

In addition to custom assay development, our CADI capabilities include biotherapeutic discovery, custom reagents and packing, and sample testing services.

Biotherapeutic Discovery

The ability to assess safety and performance quickly and accurately is critical to the development of biotherapeutics. The high sensitivity SMC^® technology accelerates this development via custom assays for:

• Immunogenicity
• Pharmacokinetics
• Pharmacodynamics
• Micro-dosing and toxicology studies

Custom Reagents and Packaging

When you want premixed beads to conserve assay set-up time or would like individual components or custom pack sizes for automation or to maximize limited storage space, the following options are available:

• Custom antibody*-coated beads/magnetic particles
• Custom labeled detection antibodies*
• Bulk or custom pack sizes for MILLIPLEX^® components and/or SMC^® components
• Premixed beads for MILLIPLEX^® assays without premixes or custom premix part numbers

 *Client-provided antibodies or CADI-sourced and screened antibodies.

Sample Testing

We offer non-CLIA/non-GLP, fit-for-purpose sample testing for custom and commercially available assays on the SMC^® platform to evaluate potential biological relevance in real samples and to identify biological anomalies that may occur due to drug interference or matrix effect. Connect with your local sales specialist to request a quote for a sample testing project or to try our SMCxPlore^™ Proof of Concept (POC) Sample Testing service. With this introductory assay service, we will test up to 30 of your critical samples using one of our highly verified commercially available kits to demonstrate how SMC^® technology meets your experimental needs.

The SMC^® High Sensitivity miR-122 Liver Injury Detection Assay is the latest addition to our sample testing menu. This early-access kit enables the quantification of miR-122 in your serum, plasma, and cell media supernatant samples with minimal hands-on steps. Watch this webinar to see how SMC^® technology is being used in toxicity studies to enable early and accurate detection of low-abundant miR-122, a specific and sensitive biomarker that can be used to evaluate drug safety profiles earlier in drug development to minimize financial loss from late-stage failure.

Contact your local sales specialist to take advantage of this service by filling out the form on our CADI page.

Note: All custom assays and reagents are intended for research use only (RUO) and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.

CADI: The Custom Assay Development Partner You Trust

Why should you partner with CADI to help advance your research? In addition to our proven assay development expertise across multiple immunoassay platforms, we pride ourselves in offering white-glove service. Learn how our custom assays accelerated pediatric lupus research in the video below.

Proven Assay Development Expertise Across Multiple Platforms

With decades of immunoassay development expertise, we are committed to delivering the best possible immunoassays for your research needs. Whether you require a MILLIPLEX^® multiplex panel to broadly survey multiple analytes, femtogram/mL biomarker analysis using the Single Molecule Counting (SMC^®) ultrasensitive immunoassay platform, or single protein detection with a tried-and-true ELISAs, you can confidently expect a knowledgeable scientific partner to create an assay that generates reliable measurements to help drive your biomarker project from hypothesis to publication.

Scientific Partnership With White-Glove Service

From beginning to end your journey will be an interactive, iterative process as you work closely with our team to define your requirements and fulfill your research goals. Throughout the project, you will receive incremental progress updates and have easy direct access to the scientific team for questions and discussions related to the project. These collaborative milestone reviews confirm your specifications and schedule are met.

We also support requests for additional documents such as:

• Confidentiality/non-disclosure agreements
• Service agreements
• Time-delimited analyte/kit exclusivity agreements

Capabilities Beyond The Science

In addition to our assay development and sample testing expertise, we can leverage other areas within our global organization. For researchers requiring reproducible production under our quality systems and additional supply chain security, we can transfer assay production from our R&D team to our ISO 9001 certified Manufacturing site. And for researchers interested in co-development projects to commercialize new biomarkers, our expansive supply chain provides access to researchers worldwide.

You can also take advantage of other products within our Life Science portfolio to drive scientific breakthroughs.

• Contract ZooMAb^® antibody development services to generate recombinant monoclonal antibodies when existing reagents are not available or are not appropriate for your application.
• Explore our complete range of reagents and enzymes for cell lysis and protein extraction which provides you with an array of options so that you can put together the perfect extraction protocol for your particular cells and protein.
• Use Duolink^® Proximity Ligation Assays (PLA) to detect and visualize protein-protein interactions and post-translational modifications with a custom MILLIPLEX^® assay or SMC^® assay to quantify downstream effects.

Request Info on Custom Services

Curious about our CADI capabilities and services? Click the button below to request more information or contact your local sales specialist. The CADI team is happy to discuss how our extensive experience can meet your immunoassay needs. You can also find answers to common questions on our CADI FAQs page

For Research Use Only. Not For Use In Diagnostic Procedures.

Related Webinars

See how researchers are using our custom services in the webinars below.

• miRNA as a Novel Toxicity Biomarker
• xPLOREing possibilities on the SMCxPRO^® platform: Development of an ultra-sensitive PK assay using custom assay services
• Assay Development for Quantification of Low-Abundance Proteins Using Single Molecule Counting
• Custom Assay Development and Services Utilizing Single Molecule Counting (SMC^®) Technology
• High-sensitivity immunoassays for biomarkers of Huntington’s disease
• Quantification of Mutant and Total Huntington Protein Levels
• Custom Services Utilizing SMC^® Technology