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From PBMC processing to immunogenicity testing and molecular analysis — integrated services that protect your samples and strengthen your data, from first preclinical dose through long-term patient follow-up.
From first preclinical dose through long-term patient follow-up, the biological events along the way are measurement opportunities. Accelevir is built to follow the cascade — across the modalities, phases, and regulatory standards your program demands.
CAP / CLIA Certified
BSL-2 Certified
Hopkins Spinout
Therapeutic Modalities
Preclinical Through Phase 3
Regulatory Framework Evolves
Every engagement starts with the biology — not the assay menu. We follow the cascade your therapeutic creates and work backwards to the measurement strategy that captures the critical events.
One biological event leads to the next. LNP uptake precedes translation. Translation precedes ADA formation. ADA formation precedes neutralization. We design measurement programs that follow the chain — so no signal goes undetected because it wasn’t on the SOW.
What you need to measure in a rat biodistribution study is different from a Phase 2 patient cohort. We scope every program with the end phase in mind — so the assay developed preclinically is the same one your regulator sees in your BLA.
RUO for discovery. Fit-for-purpose for early clinical. GLP, CAP, or CLIA when your program demands it. We don’t force every study into the same compliance box — we match the framework to where you are.
Phase 2 and beyond generate longitudinal samples that require consistent, credible measurement over years. Our CAP/CLIA infrastructure and biobanking strategy are built for exactly this arc.
One conversation with a scientist who understands your program from the inside.
The biological cascade changes at each phase — and so should the measurement strategy that captures it.
Building the right assays — and generating the early data — before the biology gets complex.
Translating preclinical methods to GLP/clinical-grade in real human matrices — while standing up the exploratory assays that surface tomorrow’s endpoints.
Maturing exploratory assays into qualified, validated endpoints — and holding measurement consistent across larger cohorts and longer timelines.
Fully validated, registration-grade data packages built for regulatory submission — and a partnership ready to carry methods into post-approval.
CAP/CLIA-certified, BSL-2 capable laboratories — directly run by senior bioanalytical scientists. No hand-offs to a queue, no PhD on a coversheet who never touches your data.
Samples processed annually
Certified facility
Scientist-run, no hand-offs
The biological events differ across RNA, gene, cell, protein, and vaccine programs — and so does the measurement strategy each one demands.
LNP delivery efficiency, expressed-protein PK, innate-immune activation, and ADA/NAb — measured along the full delivery-to-expression chain.
Capsid immunogenicity, transduction efficiency, biodistribution, and anti-AAV neutralizing antibodies across the vector lifecycle.
Persistence, phenotype, cytokine storm and CRS monitoring, plus anti-CAR antibodies — measured longitudinally as the product engrafts.
ADA tiered platform, PK by LBA, neutralizing antibodies, and functional immunology biomarkers for antibody and conjugate programs.
Viral load, pathogen quantification and sequencing, neutralizing antibodies, T-cell response, and PBMC-based functional readouts.
Bring your modality and phase — we’ll show you exactly which biological events to measure and when.
Each capability covers a distinct arc of the biological cascade — and runs on shared samples, shared data, and shared scientists.
Validated tiered ADA platforms and neutralizing-antibody assays from screening through confirmation and titer.
PK by ligand-binding assay and LC-MS/MS, plus molecular quantification by digital and qPCR.
ELISpot, intracellular cytokine staining, and cell-based functional assays measuring true biological response.
High-parameter immunophenotyping and cell-persistence panels for cell and immunotherapy programs.
Pathogen and vector sequencing, integration-site analysis, and molecular quantification by NGS.
Same-day PBMC processing, viability-optimized cryopreservation, and chain-of-custody biobanking.
A sample sitting in a queue is a sample degrading. Time-sensitive readouts — PBMC viability, cytokine profiles, transcript integrity — don’t wait for the next available bench.
Every Accelevir program is run by senior scientists who process on receipt — not when it’s convenient. Same-day handling, documented chain-of-custody, and a queue you can actually see.
— Translational scientist, partner program
How anti-drug antibody assays should be designed alongside the molecule they measure — not bolted on at Phase 1. Read Blog.
8 MIN READ · IMMUNOGENICITY
Maintaining viability and functional integrity across years of longitudinal patient sampling. Read Blog
CASE STUDY · BIOBANKING
Pre-existing immunity, assay cut-points, and what your screening NAb actually gates. Learn More.
METHOD · GENE THERAPY
One conversation with a scientist who understands your program from the inside — from your first preclinical question to your last patient visit.
Baltimore, MD · CAP / CLIA Certified · JHU Spinout