What Immunologix Laboratories does

Immunologix Laboratories (legal entity Biologics Development Services LLC) is a contract research organization founded in 2012 and headquartered in Tampa, Florida, providing GLP and GCP-compliant bioanalytical and biomarker laboratory services for biologic, cell and gene therapy, and nucleic acid-based therapeutics. The company operates from a 33,000 sq ft facility with a horizontal segmentation approach serving both large pharmaceutical companies and smaller biotechnology enterprises across the full drug development lifecycle. Its service portfolio spans Bioanalytical Sciences (PK assays), Immunogenicity (ADA/NAb), Cell Based Assays, Biomarker Sciences, Critical Reagents, Gene & Cell Therapy analytics, Flow Cytometry, and a Translational Sciences advisory practice.

The firm's core platform integrates laboratory capabilities with translational consulting through a Scientific Triad Model that assigns each project a Principal Investigator, Translational Scientist, and Lead Method Developer, supported by daily cross-disciplinary scientific office hours. Technical differentiators include deep expertise in ligand binding, cell-based, and qPCR assays; a proprietary heat-inactivation protocol for resolving target interference in ADA assays; and rigorous regulatory compliance including 21 CFR Part 11, SOC 2 Type II, GDPR, and EU-US Data Privacy Framework certifications.

The business model is project-based professional services, with revenue generated through assay development, validation, and sample analysis engagements, plus fully integrated FTE models embedding translational scientists directly into client project teams. Go-to-market is sales-led through direct scientific consultation, with senior leadership actively contributing to industry bodies such as the European Bioanalysis Forum to reinforce thought leadership. The company is privately held, founder-led, and has not disclosed external institutional funding.

Name

Immunologix Laboratories

Legal name

Biologics Development Services LLC

Website

https://immunologixlabs.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

51–100 employees

Short description

Immunologix Laboratories is a Tampa-based GLP/GCP-compliant contract research organization founded in 2012 that provides bioanalytical, immunogenicity, biomarker, and gene & cell therapy laboratory services to pharmaceutical and biotechnology clients across drug development phases.

Ownership category

akta.pro rank

Product category

Contract Research Organization (Bioanalytical Laboratory Services)

NAICS

Medical Laboratories (621511), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industries

Clinical Research & Trial Central Laboratories (HLAFAMAL), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

Keywords

• Bioanalytical laboratory services
• Immunogenicity testing services
• Biomarker assay development
• Cell and gene therapy assays
• Contract research organization

Headquarters

HQ city

Tampa

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Laboratory Services: Project-based laboratory services for bioanalysis, immunogenicity testing, biomarker assays, and cell & gene therapy support. Revenue generated through scientific partnerships delivering assay development, validation, and sample analysis services across drug development phases.
2. Translational Sciences Consulting: Strategic scientific consulting including bioanalytical strategy development, regulatory engagement support, and integrated FTE models for direct client project team engagement.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Immunologix Laboratories provides GLP and GCP compliant bioanalytical and biomarker laboratory services for drug development programs, focusing on large molecule biologics, cell and gene therapies, and nucleic acid-based therapeutics. Each project is staffed under a scientific triad model combining a Principal Investigator, Translational Scientist, and Lead Method Developer, and the company integrates strategic drug development consulting with hands-on laboratory capabilities.

Product overview

Immunologix Laboratories (legal name: Biologics Development Services LLC) provides integrated laboratory and scientific services for drug development as a contract research organization (CRO). Founded in 2012 and operating from a 33,000-square-foot facility in Tampa, FL, the company offers a comprehensive suite of bioanalytical and biomarker laboratory services. The core offerings include Bioanalytical Sciences (PK assays), Immunogenicity Services (ADA/NAb assays), Cell Based Assays, Biomarker Sciences, Critical Reagents services, Gene & Cell Therapy Services, Flow Cytometry, and Translational Sciences advisory capabilities. The company operates under a scientific triad model where each project team includes a Principal Investigator, Translational Scientist, and Lead Method Developer, providing GLP and GCP compliant laboratory capabilities focused on biomarkers and bioanalysis of biologics, cell and gene therapy, and nucleic acid-based therapeutics.

Differentiator

Problem solved

Functional benefit

Products and services

• Bioanalytical Sciences Pharmacokinetic (PK) assays in support of large molecule, cell and gene therapy, and nucleic acid-based biotherapeutics drug development programs.
• Immunogenicity Services Anti-drug antibody (ADA) and neutralizing antibody (NAb) assays supporting all biologic modalities, including cell and gene therapy and nucleic acid-based therapeutics.
• Cell Based Assays Supporting neutralizing antibody, cell proliferation, potency, and cell-based PK assays for drug development programs.
• Biomarker Sciences Context-of-use driven de novo, multiplex, and commercial kit assays for biomarker detection and quantification across drug development phases.
• Critical Reagents Critical reagent labeling and analytical characterization services including biotin and ruthenium/SULFO-TAG labeling via NHS-ester functional group conjugation.
• Gene & Cell Therapy Services Pharmaco/cellular kinetics, PD, safety, immunogenicity, biodistribution, expansion, persistence, cytokine analysis (CRS monitoring), and phenotypic analyses for cell and gene therapy programs.
• Flow Cytometry Flow cytometry analytical services for cellular analysis in drug development programs.
• Translational Sciences Integrated drug development and laboratory sciences expertise providing scientific advising, therapeutic molecule specific biomarker and bioanalytical strategies, and fully integrated FTE models embedded directly on client project teams.

Quantifiable outcome

• Successfully applied simplified preclinical immunogenicity approach delivering clinically relevant data more rapidly and at significant cost savings compared to standard three-tiered method
• +1 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature4 records

Partnerships

One partnership is on record.

• European Bioanalysis Forum (EBF)coreStrategic or Co-development Partner · 1 January 2023Immunologix actively participates in the European Bioanalysis Forum, contributing to industry dialogue on immunogenicity testing strategies. Chief Scientific Officer Dr. Lauren Stevenson presented at the EBF Autumn Focus Workshop in 2023 on challenging current paradigms for ADA testing, contributing to the development of industry guidance.

Scale indicators2 records

Expansion highlights6 records

Broad incumbents

• Labcorp Drug Development (Fortrea): Major CRO providing central lab, bioanalytical, immunogenicity, and biomarker services across all therapeutic areas; competes for the same large pharma and biotech clients.
• PPD (Thermo Fisher Scientific): Thermo Fisher's clinical research business offers bioanalytical, immunogenicity, and biomarker services as part of an end-to-end CRO platform serving global biopharma.
• IQVIA: Global clinical and bioanalytical services provider with extensive bioanalytical and central laboratory capabilities serving large pharma across all phases of drug development.
• Charles River Laboratories: Large global CRO with dedicated bioanalytical, immunogenicity, and biomarker services spanning discovery through clinical phases; offers overlapping capabilities as part of a much broader portfolio.
• Q² Solutions (IQVIA/Quintiles joint venture): Central and specialty laboratory services provider offering bioanalytical, biomarker, immunogenicity, and flow cytometry services for clinical trials globally.
• Eurofins Bioanalytical Services: Global bioanalytical services network within Eurofins providing PK, immunogenicity, and biomarker assays for biologics and small molecules across regulated studies.

Direct peers

• Celerion: Mid-size CRO focused on early-stage clinical pharmacology, bioanalytical, and immunogenicity services for small and large molecules—similar specialty positioning and client mix.
• BioAgilytix Labs: Specialty bioanalytical CRO focused on large molecule PK, immunogenicity (ADA/NAb), and biomarker assays for biologics and cell & gene therapy—nearly identical service mix to Immunologix and similar mid-market positioning.
• Worldwide Clinical Trials: Mid-tier global CRO with bioanalytical and scientific affairs capabilities serving mid-size and large pharma across complex therapeutic areas—comparable scale and client base to Immunologix.

Emerging players

• Intertek Pharmaceutical Services: Provides bioanalytical and immunogenicity services for biologics and gene therapy programs, with growing focus on advanced therapy bioanalysis—partial overlap with Immunologix's cell & gene therapy offering.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biologics-development-services

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Immunologix Laboratories