Bioanalytical Laboratory Services

Accelerate therapeutic development with high-quality, customizable, and regulatory-aligned bioanalytical solutions.

• Comprehensive support from discovery through Phase I–IV clinical trials
  
• CLIA-certified and GLP-compliant environment with extensive automation
  
• Molecular, cellular, and immunological assay expertise integrated under one roof

End-to-End Bioanalytical Services for Drug Development

Accelevir offers a unified suite of bioanalytical services to support small molecule, biologic, vaccine, and cell and gene therapy programs. Our mission is to partner with biotech and biopharma innovators to transform complex questions into validated, regulatory-ready data.

Our clients trust us to:

• Design and validate custom assays for PK/PD, ADA, and biomarkers
• Execute highly sensitive molecular assays using qPCR/ddPCR
  
• Develop immunoassays and flow cytometry panels for immune monitoring
  
• Support viral vector quantification and genome integrity analysis
  
• Deliver consistent, reliable results within rapid timelines
  

We support the full drug development continuum:

• Preclinical research and IND-enabling studies
  
• Phase I–III clinical trial testing
  
• Post-marketing surveillance and Phase IV studies

Whether you need exploratory biomarker discovery, companion diagnostic development, or GLP-compliant immunogenicity testing, our lab offers scalable support aligned with your program’s complexity.

Assay Development and Scientific Innovation

Custom Assay Development

Our cross-functional team collaborates with sponsors to develop customized, high-sensitivity assays optimized for your therapeutic modality and study objectives. Each assay is designed for fit-for-purpose performance, leveraging:

• Robust SOPs
  
• Validated platforms
  
• Stringent quality controls

Validation Models

• Research-Use Only (RUO)
  
• CLIA-certified clinical testing
  
• GLP-like validation for regulatory filings
  
• Method bridging and transfer support
  

Technologies Applied

• Digital PCR (dPCR, ddPCR)
  
• Ligand binding (ELISA, MSD, ECL)
  
• Flow cytometry and immunophenotyping
  
• NGS, Sanger, and viral genotyping platforms
  
• ADA and NAb immunogenicity workflows
  

Every method is validated for precision, specificity, linearity, robustness, and sensitivity, ensuring that your data stands up to regulatory scrutiny and internal decision-making.

Specialized Platforms and Capabilities

Molecular Platforms

• qPCR/ddPCR for quantification of transgenes, residual DNA, viral load
  
• Multiplex assays for genome integrity (AAV/LV)
  
• Gene editing tracking (CRISPR off-target, HDR, NHEJ)
  
• Biodistribution studies in tissues, fluids, and cells
  

Flow Cytometry

• Immunophenotyping of PBMCs, T-cell/B-cell panels
  
• Cytokine profiling and ICS (intracellular staining)
  
• Rare cell detection and viability assessments
  
• Up to 9-color panels on dual CytoFLEX systems
  

Ligand Binding & Immunogenicity Assays

• ADA screening, confirmatory, and neutralizing antibody assays
  
• Bridging ELISA formats and tiered risk-based testing
  
• Anti-drug antibody assay design for protein and gene therapies
  
• Isotyping and immunocomplex detection
  

Cell-Based & Functional Assays

• CTL and NK cell cytotoxicity
  
• Reporter gene and receptor occupancy assays
  
• Cell proliferation (BrdU, CFSE), viability (MTT, LDH)
  
• ELISpot/FluoroSpot for functional cytokine output
  

Genomics & Sequencing

• Viral resistance genotyping for HIV/SIV
  
• Integration site mapping (vector analysis)
  
• Mutational burden and editing efficiency analysis
  

Emerging Capabilities

• Microsampling (DBS/DPS)
  
• Nanoparticle characterization
  
• Biomarker quantification across disease indications
  

Therapeutic Areas and Application Domains

Accelevir supports a diverse range of therapeutic areas, offering customized strategies for:

• Infectious diseases (HIV, HBV, SARS-CoV-2)
  
• Oncology and immune-oncology
  
• Neurology and CNS disorders
  
• Rare and metabolic diseases
  
• Inflammatory and autoimmune conditions
  
• Vaccine development and evaluation
  

We also support companion diagnostics development, biosimilar equivalency studies, and pharmacogenomic testing across therapeutic verticals.

Cell and Gene Therapy Services

We specialize in bioanalytical support for gene-modified cell therapies and viral vector platforms:

• AAV and lentiviral genome integrity quantification via ddPCR
  
• Detection of partial, rearranged, or truncated transgene constructs
  
• Biodistribution, persistence, and vector shedding assays
  
• ADA/NAb testing for gene therapy products
  
• Custom panel development for T-cell profiling in CAR-T programs
  

Our nearly decade-long experience in vector quantification gives sponsors data to guide product design, safety assessments, and regulatory filings.

PBMC Processing, Isolation & Cell Banking

Accelevir provides end-to-end PBMC services:

• Isolation via RoboSep™ automation
  
• Subset enrichment and magnetic separation
  
• Viability assessment and cryopreservation
  
• Batch tracking and QC monitoring for longitudinal studies
  
• Customized cell panels for downstream flow or molecular testing
  

These capabilities support immune monitoring in oncology, infectious disease, vaccine, and immunotherapy trials.

Lab Infrastructure and Automation

• CLIA-certified lab environment with segregated suites
  
• Automated liquid handling for immunoassays and PCR setup
  
• Bio-Rad QX200, Qiagen QIAcuity, and Thermo QuantStudio™ platforms
  
• Sample tracking via integrated LIMS with real-time client access
  
• Scalable operations to support small-batch and high-volume trials
  

Regulatory & Quality Assurance

• Over 100 studies supported under GLP-like and CLIA conditions
  
• Assays used in IND, BLA, ANDA, 510(k), and EUA submissions
  
• QA oversight, SOP-based workflows, and ongoing training
  
• Independent audits by pharma partners and public health agencies
  

We adopt a “fit-for-purpose” approach to ensure each assay is validated for the right use case while maintaining efficiency and scientific rigor.

Why Partner with Accelevir?

• Agile team, responsive timelines, and hands-on scientific collaboration
  
• Deep virology and molecular assay expertise
  
• Proven record supporting HIV, oncology, and gene therapy studies
  
• State-of-the-art instrumentation and automation
  
• Integrated lab support from method development through regulatory submission
  

Clients choose Accelevir for our scientific precision, our consultative model, and our ability to deliver when it matters most.

Start Your Project

From digital PCR to flow cytometry and regulatory-ready ADA testing, Accelevir is your partner in bioanalytical excellence.

📧 Contact our team to discuss your project needs, timelines, and goals.

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Frequently Asked Questions

Do you develop custom assays for novel therapeutics?
Yes. We specialize in tailoring qPCR, ELISA, ADA, and ddPCR assays for new drug modalities.

Can you support both early discovery and clinical sample testing?
Absolutely. Our infrastructure and team expertise allow seamless transitions from preclinical to clinical workflows.

Do you offer biosimilar or comparator testing?
Yes. We support EUA/510(k) bridging, equivalency studies, and assay comparisons.

How do you manage regulatory compliance?
We operate under a CLIA-certified QMS, with documented validation, audit preparedness, and support for regulatory filings.

Do you have experience with AAV and CAR-T programs?
Yes. We’ve supported gene therapy programs with genome integrity, ADA, T-cell profiling, and biodistribution assays.