Your End-to-End Partner in Cell & Gene Therapy Development
Precision Testing and Integrated Support from Discovery to Clinical Trials
Accelevir is your strategic partner in developing advanced cell and gene therapies. Our services span the entire development continuum—from early discovery and vector optimization through preclinical assay development and clinical trial bioanalysis. With deep scientific expertise, CLIA-certified infrastructure, and customizable service models, we support biotech and biopharma companies in bringing transformative therapies to life.
- Viral vector quantification and genome integrity analysis
- Custom molecular assay development (dPCR, qPCR, NGS)
- PBMC processing and subset enrichment
- Immunogenicity and cytotoxicity testing
- Comparator studies and regulatory support
- Clinical manufacturing readiness and CDMO handoff facilitation
Comprehensive Cell & Gene Therapy Services
Designed to Accelerate Development and Ensure Data Integrity
Our multidisciplinary capabilities are tailored to the unique challenges of gene and cell therapies.
- Viral Vector Services
- Multiplex dPCR and ddPCR for genome integrity and payload quantification
- Single-genome sequencing to detect vector integration fidelity
- Impurity testing (hcDNA, HCP, pDNA)
- AAV and lentiviral vector assessment (proviral intactness, transduction efficiency)
- Viral infectivity and neutralization assay
- TCID50 and plaque assays
- Molecular Assay Development
- Digital PCR (dPCR/ddPCR) and qPCR assay design, validation, and tech transfer
- Next-Generation Sequencing (short-read, long-read)
- IPDA™, SCA, and viral load quantification
- SNP and mutation detection, copy number variation analysis
- Custom assays for ADA, NAb, gene expression, vector persistence
- Kit configuration for RUO/IVD and submission-ready bioanalytical platforms
- PBMC & Cell Processing
- PBMC isolation, processing, and cryopreservation
- Cell viability and fractionation
- Immunomagnetic subset enrichment
- RoboSep™ automated cell separation
- Cell banking and viability testing
- Immunology & Functional Testing
- ELISA, ELISpot, FluoroSpot
- Flow cytometry with CytoFLEX instruments (up to 9-color panels)
- Cytokine/chemokine profiling
- Cytotoxicity and cell proliferation assays
- Anti-drug antibody (ADA) and immunogenicity testing (NAb, binding antibodies)
- ADA bridging formats and neutralizing assay development
- Comparator and Regulatory Support
- CLIA-certified comparator testing for EUA/510(k) and PMA submissions
- GLP-aligned documentation and assay validations
- Consultative support for IND/BLA filings
- Assay bridging, comparability studies, and tech transfer services
- CDx development and regulatory submissions
Technologies & Infrastructure
Accelevir’s high-complexity laboratory integrates state-of-the-art platforms to support scalable, compliant testing.
Instruments and Platforms:
- Bio-Rad QX200/QXOne ddPCR systems
- ThermoFisher QuantStudio™ 5/7, Qubit, Varioskan™
- Qiagen QIAcuity, QIAxpert, QIAcube
- Beckman Coulter CytoFLEX Flow Cytometers
- Hologic PantherⓇ Fusion
- RoboSep™ automated cell processor
- Illumina and Oxford Nanopore NGS systems
- BioTek plate washers, absorbance readers
- Custom informatics and LIMS integration
Scientific & Regulatory Expertise
Our team includes PhD scientists, regulatory specialists, and experienced technicians who collaborate directly with clients to solve the complex scientific and logistical challenges of cell and gene therapy development.
- 10+ years in proviral genome integrity analysis
- 100 clinical studies supported with IPDA™ and related assays
- Regulatory alignment with CLIA, GLP, and ISO 13485 requirements
- Seamless assay development and tech transfer workflows
- Study design and pre-IND consults for FDA meetings
Therapeutic Areas Supported
- Oncology: CAR-T, TIL therapies, gene-modified immune cells
- Infectious Diseases: HIV, SARS-CoV-2, SIV/SHIV monitoring
- Rare Diseases: AAV-based gene delivery for metabolic or genetic disorders
- Autoimmune/Inflammatory: Cell-based immune modulation
- Neurology: CNS-targeting gene therapy vectors
Ready to Advance Your Cell and Gene Therapy?
From custom assays to comparator testing and immunological profiling, Accelevir helps you navigate the complexity of CGT development with confidence.
FAQs: Cell and Gene Therapy Services
Do you develop custom dPCR assays for gene therapy vectors?
Yes. Our experts design multiplex dPCR assays to evaluate genome integrity, vector integration, and expression across various constructs.
Can Accelevir handle clinical-stage sample processing?
Yes. We operate in a CLIA-certified environment with validated protocols for PBMCs, CSF, tumor samples, and more.
What immunogenicity testing do you offer?
We provide ADA, NAb, cytokine, and functional immune assays tailored for CGT candidates.
Do you offer scalable services to support CDMO or commercial readiness?
Yes. Our assays are designed for tech transfer and scale-up, supporting RUO, IVD, and regulatory needs.
Do you provide preclinical and IND-enabling studies?
Yes. Through our partnership with Noble Life Sciences, we support preclinical efficacy, toxicology, and IND package generation.
How can I initiate a cell or gene therapy project with Accelevir?
Use our contact form or reach out to our scientific team to schedule a discovery consultation.