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Going Beyond the Standard Trust Battelle to meet your assay development and validation needs.

Bioanalytical Methods

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


We go beyond standardized methods to solve some of today’s most difficult in vitro assay challenges. That’s why clients like the Centers for Disease Control and Prevention (CDC), the Department of Defense (DoD) and many commercial customers trust Battelle to meet their assay development and validation needs. 

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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At Battelle, everything we do is built around your needs and requirements.  

We offer:  

  • A flexible, adaptable approach to meet challenges as they arise and ensure that your assay fully meets your requirements

  • Deep experience with a wide range of assay types, analytes and biomarkers

  • A GLP-compliant quality system and proven ability to meet FDA requirements for validation

  • State-of-the-art facilities and equipment with biocontainment up to BSL-3 and chemical surety laboratories with the capacity for safe handling of highly toxic materials including chemical warfare nerve agents

  • High-throughput capabilities for efficient sample analysis

  • Integration of in vitro and in vivo


Our services include:
  • Real-time quantitative PCR (TaqMan®), immunohistochemistry, HPLC (for protein therapeutics and toxins) and potency assay

  • DNA microarrays for expression and MiRNA profiling

  • Massively Parallel Sequencing  for expression profiling by RNAseq of non-traditional models/bacterial and viral strain resequencing/genotyping

  • In vivo imaging including IVIS® (In-Vitro Imaging System)

  • In vitro imaging including high content IN Cell Analyzer 2000 and Flow Cytometry

  • Serological analysis using a neutralization assay, quantitation of antibody levels by ELISA, surface plasmon resonance to evaluate antibody affinity/avidity, hemagglutination inhibition assays and western blog analyses

  • Validated high-throuput botulinum neutralization and toxicity bioassays to quantify neutralizing antibody concentration and toxin activity

  • Evaluation of the host response by microarray technologies, in situ hybridization, flow cytometric assays (FACSAria, LSR II, and Guava), cytotoxicity neutralization assays and Luminex-based assays

  •  Immunoassays for detection of lymphocyte proliferation and response to antigen, cytokine secretion in multiple tissue samples, as well as bacterial quantitation

  • Microbiological (viral and bacterial) assays


Battelle offers access to an unmatched range of subject matter expertise to solve complex analytical challenges. 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.