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.
Our analytical and clinical assay performance evaluations are performed in accordance with validation procedures of the Federal Drug Administration (FDA), the International Committee on Harmonization (ICH) and the National Committee on Clinical Laboratory Standards (NCCLS).
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Battelle’s biomarker assay development and validation and other biomarker services provide innovative solutions for today’s global health challenges.
With more than 40 years of experience serving the biotechnology/pharmaceutical industry and government clients, 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.
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In Vitro Services
We develop and validate bioanalytical and anti-drug antibody assays for large and small biologics for use in sample analysis to support:
Cell Culture Services
- PK/TK Analysis
- Vaccine Efficacy
- ADME Analysis
- In Vivo Services
- Dose Formulation and Analysis
- Stability Studies
We develop and validate cell-based assays including primary and stem cell models to support cytotoxicity studies.
Battelle has been performing GLP studies since the inception of the regulations and recognizes the critical role of quality assurance in monitoring and maintaining a compliant GLP quality program.
- Independent Quality Assurance Unit
- GLP Compliance (21 CFR Part 58)
- Computer system and electronic records compliance (21 CFR Part 11)
- Organisation for Economic Cooperation and Development (OECD) and International Council for Harmonization (ICH) compliance
- Respected auditors with experience conducting and handling inspections by sponsors and federal agencies
- Platform identification and suitability evaluation
- Reagent identification, production, characterization and stability
- Method development
- Method refinement/optimization
- Reagent stabilization
- Immunoassays-singleplex, multiplex, chemiluminscent, bead-based
- RT-PCR, q-PCR
- Surface plasmon resonanc
- Flow cytometry
- Cell-based assays
- LC-MS, LC-MS/MS, GC-MS
- Multiple reaction monitoring (MRM)
Assay Performance Qualification and Validation
- Analytical performance -- precision, accuracy, linearity, range, LLOQ, LOD
- Robustness testing
- Interference studies
- Clinical performance evaluation technology transfer
- Technology transfer package preparation including reagents, SOPs, forms validation reports, training modules and videos that demonstrate the assay, data analysis software
- On-site training
- Proficiency panel production
Our teams and integrated approach is designed to provide you with the best method to meet your needs while reducing the time, risk and cost of your discovery and development programs.