Translational Biomarker Solutions

Flexible, fit-for-purpose biomarker support to propel your drug development.

• Your Needs

  Translational biomarkers can play a critical role in helping you quickly assess biomarker feasibility to better understand how it can be utilized in a clinical environment.  When it comes to analytical characterization, one size doesn’t fit all. You need a flexible approach that considers your phase of development and desired outcomes to provide the best support for the intended use of your data.

  Exploratory biomarkers, while not guided by specific regulations, still utilize robust quality principles, expertise and process to deliver high-quality and reliable data. A trusted partner who has familiarity with CAP/ CLIA and GxP environments can streamline your transition and retain critical insights about your assay and goals.

• Our Capabilities

  Since 2009, the Translational Biomarker Solutions (TBS) team has been supporting assay development and validation needs in an exploratory – but, principled – environment. Expertise in cellular analysis and immunoassays can help you develop your strategy from concept to implementation to meet your critical goals for exploratory biomarkers.  

  Specialized Support

  Immunoassays/LBA

  • Ultrasensitive
  • Custom-immunogenicity assays
  • Low-sample volume with improved detection
  • Multiplexed and specialized platform assays 
  • Electrochemiluminescence
  • Microfluidics-based ELISA
  • Kit-based immune assays
  • Immunoassay autoanalyzers
    

   

  Cellular-based Analysis

  • High-parameter immunophenotyping of blood, PBMC and tissues
  • In vitro Pharmacology
  • Immunotoxicology for cytokine release
  • Cellular Immunology
  • Cell-Based Assays (including ADCCs, CDCs, Proliferation, Apoptosis and viability, etc.)

   

  Flexible and fit-for-purpose biomarker testing solutions

  From initial feasibility and development to advanced validation, testing and production, we deliver insights to drive your decision making. Our team provides unique solutions for historic (banked) samples, difficult matrix types, or complex assay development in a flexible environment that provides robust exploration to guide new paths forward in biomarker discovery. As your clinical biomarker needs evolve, the TBS team can help you transition seamlessly into a CAP/CLIA or GxP environment for qualification, method validation and implementation.

  Extended reach with access to the optimal technologies

  Comprehensive knowledge of assays spanning ultrasensitive and multiplexed, kit-based and custom-built, low-sample volume and cell-based, gives you an experienced partner with access to a toolbox of diverse platforms. Together, we can support your biomarker analysis and advance your discovery through the use of precision technology, such as:

  • Quanterix Simoa
  • Meso Scale Discovery (MSD)
  • Luminex
  • Protein Simple ELLA
  • Gyros
  • ECLIA (Roche e601)
  • Octet
  • Cytoflex (Beckman Coulter 6-color)
  • Miltenyi Automacs Pro
  • Miltenyi Octo Dissociator
  • BD Fortessa X-20 (18-Color)
  • CTL ImmunoSpot

   

   

  A quality approach to biomarkers in a non-regulated environment

  In parallel with our regulated lab work, the TBS team works under a set of standardized quality principles to ensure accuracy and quality for your exploratory objectives of the studies. This system is further verified by both internal and external QA audits, as well as proficiency testing, giving you confidence that the data produced meets the highest standard of quality. 

  Working with TBS, you get a set of reliable and reconstructable results that enables informed development decisions and a structured transition to the regulatory environment required to progress to your next milestone. 

  Next, meet the team that will work with you to help solve your translational biomarker challenges.