Custom Assay / Sample Testing (CAST) Services for SMC^® Technology: Assay Your Way

Trusted Outsourcing Services

Our Custom Assay / Sample Testing (CAST) services are powered by a scientific team with many years of combined immunoassay development experience, with their core expertise in SMC^® technology. Whether you need fit-for-purpose sample testing, biomarker analysis using one of our currently available SMC^® immunoassays, or development and manufacture of an immunoassay for your novel target of interest, our Custom Services team will partner with you to develop a project specific to your program requirements.

Scientific Partnership and Support

The team will work closely with you to understand and define the scope of the project and develop a customized project work plan. Throughout the project, you will receive both incremental progress updates and have easy direct access to the scientific team for questions and discussion related to the project. Final study reports are available at the end of the study and may be personalized to meet your specific needs. If your program requires GLP services, we can facilitate the technical method transfer to a CRO of your choice at any point in the Custom Assay Development process.

Custom Immunoassay Services Capabilities

Our highly skilled team of scientists can accelerate your research by developing a customized SMC^® assay for you. We adhere to the highest quality standards and provide solutions designed specifically for your research needs. We will work closely with you to develop a customized work plan to meet the scope of your project, ensuring complete confidentiality. Whether you require an assay for use in your own lab, for use with our sample testing services, or for transfer to a CRO of your choice, we have everything to meet your needs.

Collaborative Biomarker Discovery and Development

• Fit-for-purpose sample testing (non-GLP) – preclinical to early clinical studies, proprietary or SMC^® commercial kits
• Immunoassay development - prototype assay or full development, with proprietary reagents, commercial or multiplex reagents, and method transfer to manufacturing
• Biomarker kit verification (to sponsor requirements) - minimum required dilution (MRD), spike recovery, dilution linearity, cross-reactivity/interference testing, and assay/sample stability testing (freeze/thaw, real time, and/or accelerated)

Biotherapeutic Discovery

• Microdosing and toxicology studies – SMC^® technology allows quantification of smaller doses for early toxicology studies
• Pharmacokinetics - SMC^® technology enables drug metabolism measurement
• Pharmacodynamics - high sensitivity SMC^® assays can track the effects of drugs over a longer time course
• Immunogenicity - improved sensitivity on the SMC^® platform leads to safer drug development

Reagent Selection, Labeling, and Characterization

• Reagent sourcing – when you do not have time to select assay reagents
• Antibody screening and selection - we use the BLItz® system to screen the best antibodies and calibrator proteins when there are many to choose from
• Antibody derivatization - labeling of antibodies for capture and coating of microparticles, or labeling of detection reagent
• Assay stability testing

SMC^® Assay Kit Development

• Proprietary or commercial SMC^® assay kit development
• Assay kit verification
• Assay kit manufacturing
• Method transfer to contract research organizations (CRO)

Sample Testing

• R&D and prototype assay kit sample testing
• Commercial assay kit sample testing

The purpose of our sample testing is to:

• Assess potential biological relevance in real samples
• Assess biological anomalies that may occur due to such things as drug interference or matrix effect

Custom Assay Development

To accelerate your own assay development projects, we provide a variety of antibody derivatization services. Whether you provide your antibodies of choice or we source them for you, our team can derivatize and label microparticles with capture antibodies or fluorescently labeled detection antibodies. These reagents are optimized for the SMC^® immunoassay system for use in either CAST development or for your development of your own assay utilizing our optimization kits in-house. Details are provided in Table 1.

Have more questions? Visit our CAST FAQs page to find answers to common questions.

Example of Custom Services Used in Huntington’s Disease Research

Huntington’s Disease (HD) is a progressive brain disorder caused by a defect in the Huntingtin gene. HD is caused by a mutated form of the huntingtin gene, where excessive (more than 36) Glutamine repeats result in the formation of an unstable protein. This affects 5-10 in 100,000 people of European descent and is characterized by a decline in cognitive function as well as uncontrolled movement of the body. Mutant huntingtin protein (mHTT) is a key factor in neurodegeneration and accurate analysis in low levels is critical to accelerating research to ultimately find a cure for the disease.

Sample testing services through our SMC^® CAST team were used to measure mHTT with a highly verified assay offering of:

• Measurement down to 0.35 pg/mL for mHTT-Q45 (1-573)
• Measurement in Rat and Human Cerebrospinal Fluid (CSF) and cell lysates
• Small sample volumes required (10 μL of CSF per well)
• Assay is specific to Mutant Huntingtin (mHTT) Protein (>36 poly-glutamine sequence repeats)
  o Assay does not detect Wild type HTT (<23 poly-glutamine sequence repeats)

Figure 1 depicts a typical standard curve using mHTT-Q45.

Figure 2 shows how the mHTT assay differentiated between mutant and wild type protein through the use of SMC^® technology.

Description of CAST Services

See descriptions of the SMC^® CAST services in Table 2.

Interested in our custom services? Consult with our custom assay team to learn more about how our extensive assay design experience can be customized for your project needs. Contact your local immunoassay sales specialists for more information.

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

Related Webinars

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

• 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