array

Assay Development

MI TechnologyLet MI become part of your development team. Whether your project is academic research or in development as a commercial product, MI's services can ease your path to the highest quality arrays. We bring our experience of more than a decade in microarray-based assays to your project using:

Creating the most imformative array to assess specific conditions requires in-depth knowledge in a variety of highly technical fields. MI can contribute extensive expertise in early stage diagnostic assay development, assay and microarray validation, and unique manufacturing capabilities to product the most accurate and precise array for the application. From the development of an assay concept through the testing phase and onto production, MI scientists are available to you for consultation throughout the process.



Assay Development

Microarray-based assays are among of the most technical and customized products at MI. Our array technologies offer placement of a wide variety of probe types onto an array, leading to a high throughput assay for a variety of ligands. Our capabilities include moving traditional ELISA tests to a microarray format to accelerate throughput.

  • cell lysates
  • antibodies or antigens
  • small molecules
  • proteins, peptides, etc
  • oligo probes
  • clones

Using our unique manufacturing capabilities and applying extensive expertise in assay development and validation, MI scientists develop your assay concepts to achieve a robust and precise array tool for the laboratory or market. Array products may encompass a wide range of applications including:

  • moving traditional ELISA tests to array format to improve throughput
  • diagnostic and prognostic expression profiling
  • autoimmune disorder profiling
  • analyte screening
  • identification of pathogens from food, environment, or other sources

Please complete the Contact MI form to begin the process. An MI scientist will contact you with information on how we can accelerate your assay development efforts.

Diagnostic & Prognostic Arrays

Diagnostic and prognostic arrays often provide clinicians with valuable information which can result in significantly improved patient outcomes in both medical and veterinarian settings. MI's array technology offers enhanced capabilities for determining diagnosis and/or treatment based on the most pertinent data. Arrays can provide accurate and affordable testing by running many assays from an individual sample in the microarray format.

MI brings our extensive experience to the creation of a robust and precise array tool for laboratory use. Array products may encompass a wide range of applications including:

  • diagnostic expression profiling of cancers to identify cancer sub-types
  • prognostic expression profiling to direct sub-type specific therapies
  • autoimmune disorder profiling
  • pathogen detection

A pilot project is typically utilized during the development phases of diagnostic/prognostic arrays to ensure development of robust, meaningful and specifically-targeted assays. MI scientists will work with you to identify factors which may impact the successful development of the required array assay.

Regulatory Approval

Our dedication to producing the highest quality product is supported through our GMP (good manufacturing procedures). All fabrication is completed in climate-controlled labs where our scientists use GLP practices for sample handling, laboratory control, personal safety protection, and process control to achieve the best results for your project. MI supports our clients through each stage of regulatory approval processes including site certification requirements.

Please complete the Contact MI form. An MI scientist will contact you with information on how we can accelerate your diagnostic/prognostic assay development efforts.

OEM

MI provides a spectrum of product development services to our commercial clientele which ranges from corporate start-ups to Fortune 500 companies. MI is highly proficient at taking early-stage intellectual property through a rigorous process of platform design, optimization, validation and regulatory control. Regardless of our client's level of need, MI always provides a highly experienced, personal, and accessible partner willing and able to address every aspect of your array design and manufacturing.

OEM arrays are often very specialized and typically must conform to the manufacturing standards dictated by external control and regulatory agencies. MI is able to manufacture arrays to meet exacting validation parameters to match all the specific product requirements. Client-proprietary substrate surfaces or dimensions are readily accommodated on MI's unique array manufacturing platforms.

Among MI provided services for commercial OEM are:

  • De novo array design
  • Pilot projects for R+D
  • Primary OEM manufacturer
  • Replication of existing products as primary or secondary manufacturer

Custom OEM services range from the design of microarray layout and content to pilot projects for research and development testing to replication for existing products when a secondary or replacement OEM provider is required. You'll receive your array product in the exact configuration needed to integrate with your company's processes.

MI helps remove the challenges associated with new product development via innovation and creative problem solving, coupled with extensive expertise in platform development. Please complete the Contact MI form and learn how OEM services from MI can improve your company's profitability.

Custom Project Outline

Custom Project Process Diagram Assay & Microarray Design Experimental Pilot Projects Pre-Production Arrays for Testing Full Production

MI has developed a standardized process for developing Custom Projects. While the phases are quickly completed when substrates and probe materials are in common usage, array projects using a unique substrates or probe types are readily completed using this step-by-step methodology. The process consists of 5 primary phases: Project Concept and Definition, Assay and Microarray Design, Experimental Pilot Projects, Pre-Production Arrays for Testing and Full Production, each with a specific output:

Project Concept and Definition

Areas of consideration:

  • Project scope
    • specific requirements and format for results
    • limits for signal:noise ratios
  • Physical array attributes
    • substrate size and composition
    • # of probes, controls and replicates
  • Probe material physical characteristics and source(s) identified
  • # of probes, controls and replicates
  • Other client-specific requirements

Assay and Microarray Design

  • Detailed plan of assay and microarray design
    • physical layout of probes, controls, and replicates on the microarray surface
    • substrates and attachment chemistries identified for testing
    • QC requirements established
  • Hybridization protocol established

Experimental pilot project(s)

  • Test arrays printed offering alternatives for identified areas of variability
  • Pilot arrays tested by MI for quality and basic array parameters
  • Client testing of pilot arrays for compliance with assay requirements
  • Review of pilot results with client
  • Adjustments to array composition
  • Determination of 'ready-to-produce' or, when needed, creation of a follow up pilot experiment

Pre-Production arrays for testing

  • Decision made for production of a full array lot based on pilot results
  • QC requirements finalized
  • Manufacturing SOPs generated
  • Arrays supplied to customer for full-use testing to evaluate assay performance

Full Production

  • Final client approval to begin production
  • Annual volumes and call-off requirements determined
  • Periodic reviews scheduled

Please complete the project inquiry form to begin the process. An MI scientist will contact you to discuss how we can help you accelerate your assay development efforts.