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Accelevir Diagnostics provides CLIA-certified gene therapy bioanalytical service purpose-built for lentiviral vector gene therapy programs. Our pre-validated qPCR and dPCR viral vector assays deliver the sensitivity, reproducibility, and regulatory documentation required for IND submissions — potentially reducing assay development timelines compared to de novo assay builds and depending on program requirements.
For biotech and pharma teams advancing CAR-T cell therapy, hematopoietic stem cell modifications, or direct in vivo gene delivery, our assay portfolio supports the full bioanalytical lifecycle.
Coverage spans vector genome quantification, biodistribution mapping, replication-competent lentivirus (RCL) safety screening, and transgene expression analysis across preclinical and clinical phases.
Pre-qualified AAV and lentiviral assays compress IND timelines and arrive ready for regulatory review.
IND-ready, day one.
Lentiviral vector gene therapy vectors derived from HIV backbones efficiently transduce both dividing and non-dividing human cells, making them well-suited for durable gene modification in hematopoietic and other target cell populations. However, this integration mechanism introduces unique analytical and regulatory requirements that directly impact clinical development pathways. FDA, EMA, and PMDA guidelines require comprehensive biodistribution studies demonstrating tissue-specific vector accumulation, shedding assessments confirming patient and environmental safety, and persistence tracking to evaluate long-term transgene expression. Lentiviral vector safety screening for replication-competent lentivirus (RCL) remains a critical safety gate for all clinical-grade lentiviral vector production. Pre-validated assays with established, matrix-specific limits of quantification — typically in the range of 50–200 copies per µg genomic DNA, depending on matrix and target — combined with GLP-compliant documentation, and cross-species validation mitigate these risks before studies begin.
Accelevir’s deep expertise in HIV-1 genome content and its dPCR-based viral vector quantification platform provides us with a unique perspective for defining assays that measure absolute lentiviral vector copy number without standard curves. Key technical specifications include
Accelevir will customize to meet your fit-for-purpose standards and can support compliant workflows to support study submissions for
Absolute quantification for VCN determination in host cell genome.
Tissue-specific targeting across multiple organ systems.
Release testing for clinical-grade vector products.
RCL lentiviral vector safety testing using qPCR and cell-based assays.
mRNA and therapeutic protein quantification in target tissues.
Long-term assessment of proviral DNA in blood and tissue, including NGS-based integration site analysis for insertional mutagenesis and clonal expansion.
Anti-vector antibody and T-cell response characterization.
Correlation of lentiviral vector copy number with gene expression levels.
Human gene therapy regulatory submissions require comprehensive tissue distribution mapping demonstrating vector accumulation patterns, clearance kinetics, and persistence profiles. Our validated gene therapy bioanalytical service assays support
Accelevir support for CAR-T product manufacturing, infusion, and long-term follow-up.
Our CGT Assay Kit portfolio supports lot release testing with
Pre-validated assays eliminate months of method development, directly compressing IND submission schedules.
Pre-validated assays eliminate months of method development, directly compressing IND submission schedules.
Customized approach to meet your required regulatory standards.
Consider us partners through the completion of your studies.
Lentiviral vector services models accommodate early-stage biotech proof-of-concept studies through large pharma pivotal programs.
“With your support of [our] therapeutic vaccine trial, we were able to quickly generate unbiased data with cutting-edge assays to evaluate the impact of a novel T cell-based therapeutic vaccine in a randomized clinical trial. Given our success working with your group, we have several planned studies testing novel interventions.”
“As an in vivo CRO, we rely heavily on strong bioanalytical partners—and working with Accelevir has truly elevated the quality of our studies. They feel like an extension of our team, consistently delivering high-quality, reliable data quickly and giving our sponsors real confidence as they move their programs forward.”
“Over the course of our interactions, we have been impressed by the [Accelevir’s assays] to support both research studies and clinical trials. We look forward to continuing to work with your group.”
“Your assay development and refinement exemplifies the power of our platforms … by thoughtfully leveraging the unique precision, sensitivity, single template multiplexing, and linkage determination capabilities of digital PCR.”
Standard biodistribution and lentiviral vector copy number assays deliver results within 2–3 weeks. RCL cell-based assays require 4–6 weeks due to amplification requirements using standard cell-based protocols; interim qPCR screening can support accelerated release decisions.
Pre-validated assays arrive with complete qualification documentation — specificity, sensitivity, precision, accuracy, and robustness data — eliminating the validation phase typically required for novel method development.
Our assays align with FDA retroviral vector testing guidance, EMA lentiviral vector gene therapy development guidelines, PMDA requirements, and ICH guidelines for global regulatory acceptance.
Yes. Cross-species validated assays enable seamless data continuity from mouse and NHP preclinical studies through human clinical trials using identical methodologies.
Complete validation reports, method SOPs, certificate of analysis templates, and regulatory submission-ready data packages formatted for IND, BLA, and MAA filings.
Accelerate your lentiviral vector gene therapy development timeline with pre-validated gene therapy bioanalytical service assays designed for regulatory success.
Contact Us to discuss your lentiviral vector services needs with our scientific team.
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