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Provider profile

NorthEast BioLab.

Bioanalytical services

NorthEast BioLab describes bioanalytical services: method development, validation and sample analysis, PK, immunogenicity, biomarker, cell-based, flow cytometry and qPCR/ddPCR assays on LC-MS/MS and ligand-binding platforms, for small molecules, peptides, oligonucleotides, antibodies, ADCs, vaccines and cell and gene therapies, IND-enabling to first-in-human. Its laboratory is in Hamden, Connecticut (US).

Website
nebiolab.com (opens in a new tab)
Sources reviewed
November 3, 2026 · Source pages re-checked within 4 months
First published
November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Services and capabilities

  • Biomarker assays4,5
  • Cell-based assays2
  • Flow cytometry3
  • Immunogenicity (ADA/NAb)4
  • Method development1
  • Method validation2
  • Molecular assays (qPCR/ddPCR)3,4
  • PK/TK bioanalysis4
  • Regulated study-sample analysis3

Platforms and methods

  • LC-MS/MS3,4
  • Ligand-binding assays2,3,4

Sample types

  • Cerebrospinal fluid5
  • Plasma and serum5,6
  • Tissue5,8
  • Urine5,7
  • Whole blood8

Development experience

Development experience

Development stage

  • Phase 15
  • Preclinical5

Modality

  • Antibody-drug conjugates4,5,7
  • Cell therapies2,6,8
  • Gene therapies4,8
  • Monoclonal antibodies4
  • Oligonucleotides4,5
  • Peptides4,5,6
  • Recombinant proteins7
  • Small molecules4,5
  • Vaccines2

Locations

Locations

  • Hamden, United States · Laboratory2Company address in site footer; job adverts list bioanalysis roles in Hamden, CT

Quality and regulatory

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

  • CAP accreditation3Stated for clinical biomarker testing under CLIA
  • CLIA3Stated for clinical biomarker testing
  • GCLP2,4
  • GCP4
  • GLP4

Unknowns and questions to ask

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

  • Whether a validated method already exists for your molecule or a close analogue, and who owns it
  • Validation scope against ICH M10 for your assay type, and expected timeline
  • Current instrument and analyst capacity, and turnaround per sample batch
  • Sample receipt, storage conditions, chain of custody and international shipping experience
  • Most recent regulatory inspection or audit outcomes relevant to your studies
  • Data-integrity controls and the format of data delivered to your PK or biometrics vendor

How to select a bioanalytical laboratory

Evidence and sources

Evidence and sources

  1. 1ADA Assay Design per FDA Immunogenicity Guidance (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2Bioanalytical CRO: PK, ADA, Cytokine & Cell-Based Assays (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3Biomarker CRO: Assay Development, Validation & Strategy (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Bioanalytical Lab Services: Assay Development & Validation (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5LC-MS/MS Bioanalysis CRO for PK & Biomarkers (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  6. 6Immunogenicity Testing: ADA & NAb Assay Services (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  7. 7Mass Spectrometry Services for Bioanalysis (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  8. 8ddPCR & qPCR Services for Cell and Gene Therapy (opens in a new tab)NorthEast BioLab · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

Something out of date or wrong? Request a correction. Corrections are reviewed against public sources before publication.

Contact

Contact

Contact the provider directly through its public contact page (opens in a new tab). ArgusBio does not forward inquiries to providers and does not receive referral fees.

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