Cambridge Biomedical

What Cambridge Biomedical does

BioAgilytix Labs is a global bioanalytical contract research organization (CRO) providing pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical services to pharmaceutical and biotechnology clients across all phases of drug development, from discovery through commercial CMC. The company is structured around a multi-platform laboratory stack spanning Ligand Binding Assays/Immunoassays, Cell-based Assays, Virology, Molecular Assays (including PCR, qPCR, ddPCR), and Mass Spectrometry, operated on instrument platforms such as MSD, Luminex, Biacore, Gyrolab, LC/MS, Flow Cytometers, and ELISpot, supported by lab automation. Coverage extends across modalities (large molecules, small molecules, advanced therapies/ATMPs, and vaccines) and service types (DMPK, PK/PD, immunogenicity, biomarkers, CMC bioassays and biophysical characterization, QC release and stability testing, plus consulting).

The company has been in operation for over 30 years and is privately held with no publicly disclosed revenue or external investor information in the source materials. It operates a global laboratory footprint including its 285,109 sq. ft. Research Triangle Park Campus in Durham/Morrisville, NC (US headquarters), a 34,000 sq. ft. San Diego lab, a 22,205 sq. ft. Boston lab, a 3,222 sq. meter Hamburg lab (EU headquarters), the 360biolabs subsidiary in Brisbane and Melbourne (Australian headquarters), and partner labs in Beijing, China. Headcount is stated at 1,100+ employees and growing, with throughput reported at 800+ assays developed and 5,000,000+ tests reported annually.

The business model is a professional services CRO engagement: project-based contracts delivered under GxP-compliant quality systems, scoped via a consultative 'Speak to a Scientist' sales motion targeting top global pharmaceutical companies, rising biotechs, vaccine developers, ATMP developers, and agricultural biotechnology firms. Pricing is not publicly disclosed and is quoted on a project-by-project basis following scientific consultation. The marketing approach combines content, scientific thought leadership, the direct scientist consultation channel, industry events, and social channels (LinkedIn, X, YouTube), with distribution handled via direct enterprise sales rather than third-party intermediaries.

Name

Cambridge Biomedical

Legal name

BioAgilytix Labs

Website

https://cambridgebiomedical.com

Company type

Private

Founded year

1990

Operating status

Operating

Headcount range

51–100 employees

Short description

BioAgilytix Labs is a global bioanalytical CRO providing pharmacokinetic, immunogenicity, biomarker, and CMC analytical services to pharmaceutical and biotechnology clients across drug development phases, operating GxP-compliant laboratories in the US, Europe, and Australia.

Ownership category

akta.pro rank

Product category

Bioanalytical Contract Research Services

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

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

akta.pro secondary industries

Clinical Research & Trial Central Laboratories (HLAFAMAL), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD), Transcriptomics & Gene Expression Profiling Services (HLAGANAE)

Keywords

• Bioanalytical services
• Pharmacokinetics testing
• Immunogenicity assays
• Biomarker analysis
• CMC analytical services

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Bioanalytical Contract Research Services: BioAgilytix generates revenue through contracted bioanalytical testing services for pharmaceutical and biotech clients across drug development phases. Services include pharmacokinetics, immunogenicity, biomarker testing, and CMC analytical services. The revenue model is project-based with contracts spanning discovery through CMC phases, likely with milestone-based billing tied to study completion and regulatory submissions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

Cambridge Biomedical operates a global bioanalytical contract research laboratory providing pharmacokinetics, immunogenicity, biomarker testing, and CMC analytical services to pharmaceutical and biotechnology clients. Services span drug development from discovery through CMC phases, covering large molecules, small molecules, advanced therapies (ATMPs), and vaccines in GxP-compliant environments. The offering is supported by a multi-platform technology stack including ligand binding assays, cell-based assays, virology, molecular assays, and mass spectrometry instrumentation.

Product overview

BioAgilytix is a global bioanalytical contract research organization (CRO) offering a comprehensive portfolio of laboratory services for the pharmaceutical and biotechnology industries. The company's service offering encompasses pharmacokinetics (PK), immunogenicity, biomarker, and CMC (Chemistry, Manufacturing and Controls) analytical services delivered across multiple modalities including large molecules, small molecules, advanced therapies (ATMP), and vaccines. The service portfolio includes assay development and validation, sample analysis, method transfer, and consulting services, supported by multiple laboratory techniques (ligand binding assays, cell-based assays, virology, molecular assays, mass spectrometry) and instrumentation platforms (MSD, PCR, Luminex, Biacore, Gyrolab, LC/MS, Flow Cytometers, and others). The company operates a global laboratory network spanning San Diego, Durham (headquarters), Boston, Hamburg, and Australia (via 360biolabs subsidiary), with partner labs in Beijing, China. BioAgilytix operates in a GxP-compliant environment supporting drug development from discovery through CMC analytical phases.

Differentiator

Problem solved

Functional benefit

Brands

• 360biolabs: Australian bioanalytical laboratory services subsidiary operating as part of BioAgilytix

Products and services

• Pharmacokinetics (PK) Services Provides pharmacokinetic analysis services including PK assay development, validation, and sample testing to measure drug concentration profiles in biological samples for pharmaceutical and biotechnology drug development programs.
• Immunogenicity Services Detects and characterizes immune responses to biologic therapeutics, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assessments, for biologic drug developers.
• Biomarker Testing Services Offers biomarker analysis across various platforms to support clinical and preclinical studies, including method development and validation, for pharmaceutical and biotech sponsors.
• CMC Bioassay Services Provides cell-based bioassay services for CMC (Chemistry, Manufacturing and Controls) analytical development, including potency and characterization assays for biologic manufacturers.
• CMC Biophysical Services Offers biophysical characterization services for biologic drug substances, including structural and physicochemical property analysis, for biologic drug developers.
• QC Release and Stability Testing Provides quality control release testing and stability studies to support regulatory filings and product commercialization for biologic manufacturers.
• Assay Development and Validation Creates and validates custom bioanalytical methods, including ligand binding assays and cell-based assays, for drug development programs.
• Sample Analysis Services Provides high-throughput sample analysis using validated methods across multiple technology platforms in GxP-compliant laboratories for pharmaceutical and biotech sponsors.
• Method Transfer Services Facilitates seamless transfer of validated assays between laboratories with full documentation and regulatory compliance support for multi-site drug development programs.
• Mass Spectrometry Services Provides LC/MS-based bioanalysis for small and large molecule quantification and characterization for pharmaceutical and biotech sponsors.
• Cell-based Assays Offers cell-based assay services for pharmacodynamic and potency measurements, including receptor binding and cell signaling studies, for drug development programs.
• Ligand Binding Assay / Immunoassay Services Provides ligand binding assay and immunoassay development, validation, and sample testing using various platform technologies for pharmaceutical and biotech sponsors.
• Virology Services Provides virology assay services, including viral clearance and antiviral efficacy testing, for biopharmaceutical development.
• Molecular Assays Offers molecular biology assay services, including PCR, qPCR, ddPCR, and other nucleic acid-based testing methods, for drug development programs.
• Consulting Services Offers regulatory and scientific consulting to support bioanalytical method development, validation, and regulatory submission strategies for pharmaceutical and biotech sponsors.

Quantifiable outcome

• 800+ assays developed annually
• +3 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

One partnership is on record.

• 360biolabscoreTechnology or Integration360biolabs is an Australian laboratory services company that operates as 'a BioAgilytix Company,' expanding BioAgilytix's presence in the Australian market with laboratory locations in Brisbane and Melbourne. The partnership provides access to Australian clinical trial advantages and extends BioAgilytix's global laboratory network.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Eurofins Scientific: Global bioanalytical and central laboratory services provider offering PK, immunogenicity, biomarker, and CMC testing for pharma/biotech sponsors. Directly comparable in service mix, multi-platform instrumentation, and sponsor customer base.
• Intertek Pharmaceutical Services: Provides bioanalytical, CMC, and pharmaceutical testing services with global laboratory footprint. Comparable in regulated analytical services and enterprise pharma customer base.
• Worldwide Clinical Trials: Mid-sized CRO providing bioanalytical, clinical pharmacology, and Phase II/III services. Comparable in scale, scientific-led positioning, and enterprise pharma/biotech customer focus.
• SGS Health Sciences: Global testing, inspection, and certification company with significant bioanalytical and central laboratory services for clinical trials. Comparable in regulated GxP lab operations and global lab network.
• Celerion: Specialized early-stage clinical and bioanalytical CRO focused on PK, ADME, and first-in-human studies. Directly competes for Phase I bioanalytical work and shares a similar specialty positioning.
• Pharmaron: Integrated CRO/CDMO with bioanalytical, DMPK, CMC, and clinical services from US, UK, and China labs. Comparable in service breadth, modality coverage, and global footprint.
• Frontage Laboratories: Specialty CRO providing bioanalytical, CMC, and preclinical services with strong presence in US and China. Closest publicly traded comparable in service mix (PK, immunogenicity, biomarkers) and modality coverage.

Broad incumbents

• Charles River Laboratories: Major CRO with bioanalytical, safety assessment, and CMC capabilities serving global pharma/biotech. Larger and more diversified than BioAgilytix but directly competes for bioanalytical work, particularly in regulated GxP environments.
• IQVIA: Largest global CRO with bioanalytical and central laboratory services bundled into full-service clinical offerings. Larger and broader than BioAgilytix but a major competitor for enterprise pharma bioanalytical work.
• Fortrea (formerly Labcorp Drug Development): Large clinical CRO with established bioanalytical and central laboratory services after Labcorp's CRO spin-out. Competes across the full clinical development lifecycle and offers broader integrated packages.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/cambridgebiomed
• YouTubeyoutube.com/channel/UC8vsHj5y8xqsLMrBg5QhA5w
• LinkedInlinkedin.com/company/cambridge-biomedical-inc
• Facebookfacebook.com/cambridgebiomedical

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

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 Cambridge Biomedical