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Assay Development & Validation

Battelle’s comprehensive experience in developing, validating and performing assays for nonclinical and clinical biomarker evaluation for pharmaceutical product and diagnostic development, coupled with our regulatory compliance expertise, helps accelerate the pace and productivity of drug discovery and development programs.

Applications

We go beyond standardized methods to solve some of today’s most difficult in vitro assay challenges. 

We can: 
  • Develop and optimize novel assays that meet stringent FDA Bioanalytical Method Validation guidelines for a wide range of analytes and matrices 
  • Validate assays for Good Laboratory Practices (GLP) pre-clinical investigational new drug enabling studies and clinical trials 
  • Conduct technology transfer and validation studies for novel applications of commercially available assays 
  • Conduct commercial diagnostic platform testing and evaluation 
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Features

Battelle’s biomarker assay development and validation services span assay feasibility and optimization studies through validation and technology transfer.

Our state-of-the-art technology platforms can be utilized for measuring small chemical metabolites through multiple protein markers. Our biomarker assay development services are designed to meet your nonclinical and clinical biomarker sample analysis needs.
Our analytical and clinical assay performance evaluations are performed in accordance with validation procedures of the Food and Drug Administration (FDA), the International Committee on Harmonization (ICH) and the National Committee on Clinical Laboratory Standards (NCCLS).

Battelle’s assay service teams are composed of experienced immunologists, toxicologists, cell biologists and molecular biologists supported by best-in-class quality assurance and biostatistical teams. Our teams are designed to provide you with the best approach to meet your needs while reducing the time, risk and cost of your discovery and development programs.

Services

Bioanalytical Methods
Battelle maintains a robust bioanalytical capability to complement our agent-specific therapeutic and vaccine testing models. Learn more.

Biomarkers
Battelle’s comprehensive experience in developing, validating and performing assays for nonclinical and clinical biomarker evaluation for pharmaceutical product and diagnostic development, coupled with our regulatory compliance expertise, helps accelerate the pace and productivity of drug discovery and development programs. Learn more

Benefits

At Battelle, everything we do is built around your needs and requirements. We are the world’s largest nonprofit research organization, with access to an unmatched range of subject matter expertise to solve complex analytical challenges. At the same time, our in vitro team is dedicated to offering personalized, responsive service tailored for each individual client. We take the time to understand your requirements and develop a program that will meet your goals in the most effective, efficient and economical way possible.