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Bioanalytical Services

Expert Bioanalytical Services for Emerging and Complex Therapeutic Development Programs

CLIA-Certified Bioanalytical Testing from Discovery to Clinical Trials

Accelerate your therapeutic discovery and  development with precision bioanalytical services delivering high-quality data that meets your defined regulatory specifications. 

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Who We Are

Accelevir provides CLIA-certified bioanalytical laboratory services supporting reliable data generation, highly consultative and agile approach to deliver comprehensive bioanalytical testing across digital PCR, flow cytometry, and custom assay platforms. With proven bioanalytical CRO expertise spanning infectious disease, oncology, gene therapies, and immunology programs, we provide the specialized expertise your therapeutic development demands.

Discovery → Clinical

Regulatory-ready data, every stage.

Why It Matters

Why Bioanalytical Services Are Critical for Drug Development Success

Reliable and reproducible Bioanalytical services enable informed, real-time decisions for quantitative and qualitative assessment of cellular responses to therapeutic candidates. Seamless transition from discovery to clinical enables efficient validation of core assays and generation of required bioanalytical data to support INDs, CTAs, and/or NDAs.

Early and well-designed and executed bioanalytical lab services directly influence several critical outcomes:

01

Regulatory Decisions

FDA, EMA, and global regulators evaluate bioanalytical testing data to determine drug exposure, biological activity, and safety.

02

Dosing Strategies

Pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analyses inform dose selection, dosing frequency, and adjustments to clinical study designs. Accurate, reproducible bioanalytical measurements are essential to ensuring clinical dosing strategies are correct.

03

Safety

Bioanalytical assays inform and identify potential efficacy, dose sparing, and off-target events that may not become apparent until later stages of the clinical study.

Our Principle

As a principle, Accelevir aims to meet a Fit-for-Purpose standard in order to provide the most cost-effective and timely reporting of bioanalytical measurements.

Our Services

Our Bioanalytical Service Offerings

Bioanalytical Support Across Therapeutic Development

Accelevir provides comprehensive bioanalytical solutions supporting RNA Therapeutics, Cell and Gene Therapy, Biologics, Vaccines, and emerging modalities.

01

Bioanalytical Support for Clinical Research Organizations

We partner with CROs and Sponsors conducting multi-site clinical studies that require geographic proximity, particularly for processing time-sensitive labile blood collections. We support global sponsors requiring:

What's included
  • Assay transfer, validation, and bridging across development phases.
  • Harmonization of sample analysis across multiple laboratories
  • Scientific consultation for complex bioanalytical challenges

02

Comparator Testing & Platform Validation

Accelevir supports regulatory submissions requiring qualified comparator testing and platform validation studies.

What's included
  • Comparator testing for EUA and 510(k) pre-submission activities.
  • Assay bridging studies demonstrating assay reproducibility and robustness.
Capabilities

Core Bioanalytical Testing Capabilities

Accelevir supports a diverse range of testing, enabling harmonization and triage of PBMCs and functional cells across immunology and molecular assays.

01

Digital PCR (dPCR) & Droplet Digital PCR

Absolute nucleic acid quantification for vector copy number, biodistribution, and persistence studies.

02

Flow Cytometry Services

Multicolor immunophenotyping and functional immune cell analysis (T cell, B cell, and innate subsets).

03

Immunogenicity Testing

ADA and NAb assays evaluating anti-drug antibody responses. Ligand binding assays and cell-based platforms.

04

ELISA & ELISpot Assays

Quantification of cytokines and biomarkers to support vaccine development and immune monitoring.

05

Cell and Gene Therapy Bioanalytics

Vector integrity, genome quantification, and transduction efficiency assessments.

06

PBMC Processing

Standardized isolation, cryopreservation and quality-controlled cell recovery and processing.

07

qPCR Gene Copy Analysis Vector and payload quantification

For biodistribution and release testing.

08

Cytotoxicity Assays

Cell viability and functional co-culture assays to evaluate mechanism of action endpoints.

09

Multiplex Molecular Assays

Custom pathogen detection panels and minimal residual disease monitoring using advanced techniques.

10

Clinical Bioanalysis

PK/PD study support with biomarker assays validated for clinical sample analysis. Biomarker and pharmacodynamic assay support across diverse biological matrices, including plasma, serum, and tissues.

Process

Our Bioanalytical Testing Process

Four-Stage Workflow

A consultative path from project assessment through regulatory reporting — designed for scientific rigor, audit-ready documentation, and reliable timelines.

01
01

Step 1

Step 1

Project Assessment and Strategy

Every project begins with a thorough evaluation of your therapeutic area, drug modality, and regulatory requirements. Our team reviews:

  • Target matrices and sample types
  • Development phase and regulatory jurisdiction
  • Existing methods requiring transfer or bridging
  • Timeline constraints and submission milestones

We recommend optimal bioanalytical approaches that balance scientific rigor with efficient timelines. This assessment ensures informed decisions before method development begins.

02
02

Step 2

Step 2

Method Development and Validation

Our scientists design fit-for-purpose assays in accordance with good laboratory practice principles and FDA/EMA guidance. Method development includes:

  • Selectivity, sensitivity, and specificity optimization
  • Calibration curve establishment with an appropriate dynamic range
  • Matrix effect evaluation across relevant biological matrices
  • Stability testing (bench, freeze-thaw, long-term storage)

Full validation generates documentation supporting regulatory submissions. For nonclinical bioanalytical support and early discovery, streamlined qualification protocols reduce timelines while maintaining data quality.

03
03

Step 3

Step 3

Sample Analysis and Data Generation

Validated bioanalytical testing proceeds with rigorous QA/QC protocols:

  • Calibration curves and QC samples at multiple concentration levels
  • Incurred sample reanalysis demonstrating reproducibility
  • Real-time data monitoring with automated sample tracking
  • Deviation documentation and root cause analysis

Our processes ensure data integrity throughout sample analysis. Electronic laboratory information systems maintain complete audit trails for regulatory inspection readiness.

04
04

Step 4

Step 4

Regulatory Reporting and Support

Comprehensive bioanalytical lab services reporting includes:

  • Full method descriptions and validation summaries
  • Chain-of-custody tracing

Ongoing scientific consultation supports regulatory interactions, assay bridging when platforms change, and adaptation to evolving regulatory expectations.

Advisory

Scientific Advisory & Consulting Services

Accelevir offers more than testing — we deliver consultative partnerships at every stage of your development program. Our PhD-level scientific team brings deep expertise in bioanalytical strategy, regulatory planning, and assay selection to help sponsors make informed decisions before costly development begins.

Our advisory services include

01

Early-stage biomarker strategy

Identify the right endpoints, matrices, and assay formats before method development begins.

02

Assay Selections for IND enabling studies

Select and prioritize bioanalytical methods aligned with regulatory submission requirements.

03

Fit-for-Purpose readiness support

QA/QC oversight and Audit preparedness.

04

Assay bridging consultation

Navigate platform changes, site transfers, and method updates without compromising data comparability

05

White-glove client onboarding

Dedicated support from project initiation through final reporting

 

Whether you are entering a new therapeutic area, encountering a novel modality, or preparing for a pivotal regulatory interaction, our team provides the scientific depth to guide your program forward with confidence.
Platforms

Our Bioanalytical Platforms and Technologies

Our laboratory is equipped with industry-leading instrumentation validated for regulatory-grade bioanalytical testing:

Instrumentation & capabilities

01

Digital PCR

QIAcuity (multiplex dPCR) and QX200 Droplet Digital PCR for absolute nucleic acid quantification

02

Flow Cytometry

Beckman Coulter CytoFLEX (up to 9-color, high-throughput immunophenotyping)

03

Automated Sample Preparation

RoboSep™ automated cell isolation and QIAcube HT for high-throughput nucleic acid extraction

04

ELISA & ELISpot

Bio-Rad iMark plate reader, Biotek plate washer, and Meso Scale Discovery (MSD) multiplex platforms

05

qPCR

ThermoFisher QuantStudio™ and Qubit fluorometric quantification

06

Next-Generation Sequencing

Short- and long-read NGS platforms for genomic, transcriptomic, and vector integration analysis

07

Bioinformatics

Statistical analysis pipelines and bioinformatics support for regulatory reporting and data interpretation

Full instrumentation details are available upon request for platform compatibility assessments and assay transfer evaluations.
Success Stories

Client Success Stories

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— Senior executive at a global life sciences company

"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."

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— Principal Investigator of a therapeutic vaccine trial

"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."

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— Managing Director of a strategic life sciences investor

"Accelevir Diagnostics is a customer-focused organization that prioritizes innovation. We recognize Accelevir's unique competency and expertise within the contract research organization (CRO) space. The company's ability to integrate scientific rigor with customer-centric solutions sets your organization apart."

FAQ

Frequently Asked Questions

What types of biological samples can you analyze for bioanalytical testing?

Our bioanalytical lab services support diverse biological matrices, including whole blood, plasma, serum, PBMCs, tissues, cell-free nucleic acids, and various specialized sample types. We establish stability protocols for each matrix to ensure reliable results.

How do your bioanalytical lab services support both preclinical and clinical studies?

We provide nonclinical bioanalysis using fit-for-purpose methods for preclinical development and fully validated assays that meet regulatory requirements for clinical trials. Our bioanalytical services span from early discovery through pivotal Phase III studies.

Can you develop custom assays for novel drug modalities like cell and gene therapies?

Absolutely. We specialize in developing and validating assays for complex molecules, including viral vectors, modified cells, mRNA therapeutics, and other emerging modalities, where our molecular and immunological platforms provide relevant analytical support. Our multiplex dPCR platforms and flow cytometry services address unique bioanalytical challenges in cell and gene therapy.

What is the typical timeline for bioanalytical method development and validation?

Assay development timelines typically range from 2–6 weeks for standard methods to 8–12 weeks for complex multiplex, gene therapy, or novel modality applications, depending on regulatory requirements and matrix complexity. Contact us early to discuss your specific project timeline.

 

Are your clinical bioanalysis services performed in a certified laboratory?


Yes. Accelevir operates a CLIA-certified, high-complexity testing laboratory with robust QA/QC protocols and documented compliance with good laboratory practice standards.

How do you ensure regulatory compliance for bioanalytical CRO projects?

We work with Sponsors to define the required Fit-for-Purpose compliance standards to ensure our workflows meet required standards.

Get Started

Start Your Bioanalytical Project Today

Accelevir has successfully completed 100+ studies and analyzed over 10,000 samples across therapeutic areas. Independently audited and trusted by industry leaders, our quality-first approach delivers validated data and deep scientific insight to power confident clinical decisions.

100+Studies completed

10,000+Samples analyzed

AuditedQuality-first

Contact us to discuss your bioanalytical needs

Whether you need a single validated assay or comprehensive program support from research through regulatory approval, our flexible engagements adapt to your development timeline and budget. Let us help you generate the quality data your program demands.

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