Bioanalytical Services
Delivering advanced, customized testing solutions to accelerate your drug development journey.
- CLIA-certified lab with digital PCR, flow cytometry, and custom assay platforms
- Proven bioanalytical support for infectious disease, oncology, gene therapy, and immunology
- End-to-end services from discovery to IND-enabling and clinical trial support
Precision Bioanalytical Testing—Tailored to Your Program
We empower biotech and biopharma innovators with bioanalytical services that are precise, reliable, and fully customizable. Our lab supports molecular and immunological assay development, validation, and sample analysis across diverse therapeutic areas and drug modalities. Whether you’re advancing gene therapy, biologics, or small molecules, our experts will tailor the right fit-for-purpose solution.
Full-Spectrum Capabilities to Support Discovery Through Clinical Development
Assay Development, Qualification & Validation
We offer regulatory-ready method development with deep technical rigor and scientific insight.
- GLP-like practices with custom or platform-based assay development
- Validation for PK, PD, TK, ADA, NAb, and biomarker endpoints
- Transition support from non-GLP discovery assays to clinical-grade testing
Molecular Assays & PCR Development
Built on our digital PCR expertise and multiplex capabilities.
- Digital PCR (dPCR) & Droplet Digital PCR (ddPCR)
- Custom multiplex assays for viral vector integrity, pathogen detection, and MRD
- qPCR and gene copy number quantification for gene therapy vectors and payload tracking
Flow Cytometry Services
Two high-throughput CytoFLEX instruments (up to 9 colors) support:
- Immunophenotyping of T, B, and innate cell subsets
- Intracellular cytokine staining (IL2, IFNg, Granzyme B, Perforin)
- Functional analysis of immune activation, proliferation, and cytotoxicity
ELISA, ELISpot, & Fluorospot Assays
Quantitative and semi-quantitative measurement of secreted proteins.
- Single and multiplex cytokine/chemokine ELISAs
- IFNg and multi-analyte ELISpot/FluoroSpot for vaccine and immune monitoring
- Humoral response profiling (antibody secretion, vaccine response)
Immunogenicity Testing
Robust ADA and NAb assay platforms to evaluate immunogenic risk.
- Ligand binding and cell-based neutralizing antibody assays
- Fit-for-purpose ADA/NAb assay development
- Anti-drug antibody (ADA) assessments across matrices
Specialized Capabilities to Meet Emerging Therapeutic Demands
Cell and Gene Therapy Bioanalytics
Gene-modified therapies require advanced tools to verify delivery and safety.
- Viral vector integrity via multiplex digital PCR
- Transduction efficiency and construct integrity assessment
- AAV & lentiviral genome monitoring pre- and post-integration
- Patient sample tracking for vector biodistribution and persistence
PBMC Processing & Cell Bank Support
We offer industry-standard PBMC handling and cellular assay enablement.
- RoboSep™-based automated isolation and cell subset fractionation
- Cryopreservation, storage, and viable cell recovery
- Immunological profiling of ex vivo and in vitro samples
Cytotoxicity & Cell Proliferation Assays
Quantitative assays for cell viability, proliferation, and drug response.
- MTT, LDH, and ATP-based cytotoxicity panels
- Co-culture and stimulation assays for NK/T cell function
- Receptor occupancy and mechanism-of-action readouts
Comparator Testing & Platform Validation
Accelevir supports EUA/510(k) pre-submissions with qualified comparator testing.
- Assay bridging, reproducibility, and robustness validation
- LC-MS comparator studies
- Full instrumentation list available for platform compatibility
Therapeutic Areas of Expertise
- Infectious Disease (HIV, SARS-CoV-2, RSV, influenza)
- Oncology (solid tumor and immuno-oncology assays)
- Immunology (autoimmune, allergy, inflammation)
- Cell & Gene Therapy
- Vaccines (prophylactic and therapeutic)
- Rare and orphan diseases
Our Platforms and Technologies
- Multiplex Digital PCR (QIAcuity, QX200 ddPCR)
- Flow Cytometry (Beckman Coulter CytoFLEX)
- Automated Sample Prep (RoboSep™, QIAcube HT)
- ELISA & ELISpot (Bio-Rad iMark, Biotek Washer, MSD)
- NGS (short- and long-read sequencing platforms)
- ThermoFisher QuantStudio™ & Qubit
- Bioinformatics and statistical analysis for regulatory reporting
Scientific Advisory & Consulting
Accelevir offers consultative partnerships at every stage of your development.
- Early-stage strategy development and biomarker planning
- IND/CTA-enabling guidance and assay selection
- Regulatory readiness support with QA/QC oversight
- Client onboarding protocols, scientific data interpretation, and white-glove support
Client Experience and Success
Accelevir has supported 100+ studies and analyzed over 10,000 samples across therapeutic areas. Our quality-first, science-forward approach delivers not only validated data, but also deep insight to power confident clinical decisions.
- Independently audited and trusted by industry leaders
- Responsive, collaborative scientific team
- Flexible engagements—from single assays to end-to-end programs
Ready to Start? Let’s Build Your Bioanalytical Strategy
Whether you’re looking for a strategic CRO partner or specialized bioanalytical testing, Accelevir delivers the innovation, quality, and responsiveness your program demands. From ideation to IND—and beyond—we’re here to accelerate your path to success.
📧 Contact us now to start your bioanalytical project or speak with a scientist.
Frequently Asked Questions
What types of samples can Accelevir process for bioanalysis?
We support a wide range of biological matrices including whole blood, plasma, serum, PBMCs, tissue, and cell-free nucleic acids.
Can you support both nonclinical and clinical-stage programs?
Yes. Accelevir’s services span from early discovery and preclinical studies through regulated clinical trial support.
Do you develop assays for novel modalities like cell and gene therapies?
Absolutely. We specialize in multiplex dPCR assays for vector genome integrity, ADA/NAb testing, and biodistribution analytics.
What is the typical lead time for custom assay development?
Custom assays typically require 2–6 weeks depending on complexity. Contact us early to discuss timelines.
Are your assays performed in a certified lab?
Yes. Accelevir operates a CLIA-certified, high-complexity testing laboratory with robust QA/QC protocols.