RESEARCH GUIDE

Biologics Characterization & CMC Analytics

Explore analytical evidence for structure, heterogeneity, potency, and comparability.

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Selected companies & service providers

Verified against public sources, selective and unranked. Drug developers and service providers are labeled separately. Unverified financing, founding dates, and current pipeline stages are not inferred.

SERVICE PROVIDER

Crystal Bio Solutions

Crystal Bio Solutions offers Biologics mass spectrometry, CMC analytics, PK, immunogenicity and biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

ProtaGene

ProtaGene offers Protein structure, impurities, potency and analytical comparability. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

BioAgilytix

BioAgilytix offers Large-molecule PK, ADA, neutralizing antibodies, biomarkers and CMC analytics. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Frontage Laboratories

Frontage Laboratories offers Analytical development, GMP release, bioanalysis and biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Charles River Laboratories

Charles River Laboratories offers Protein characterization, biosafety, PK/TK, immunogenicity and biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

SGS

SGS offers Protein characterization, potency, GMP release, stability and bioanalysis. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Eurofins BioPharma Services

Eurofins BioPharma Services offers Biologics characterization, GMP testing, bioanalysis and clinical biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Intertek

Intertek offers Protein structure, higher-order structure, GMP testing, PK and immunogenicity. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Solvias

Solvias offers Biologics characterization, impurities, potency and CMC quality testing. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Alcami

Alcami offers Biologics analytical development, validation, stability and GMP release. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Pace Life Sciences

Pace Life Sciences offers Biologics analytical testing, potency and GMP quality control. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

BioPharmaSpec

BioPharmaSpec offers Protein sequencing, higher-order structure, glycans and comparability. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Alphalyse

Alphalyse offers Mass spectrometry, protein identification and host-cell protein analysis. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Coriolis Pharma

Coriolis Pharma offers Biophysical characterization, formulation and stability of biologics. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

LEUKOCARE

LEUKOCARE offers Biologics formulation, stability and particle characterization. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

RSSL

Reading Scientific Services (RSSL) offers Biologics structure, glycans, impurities, GMP release and stability. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Biofidus

Biofidus offers Protein structure, mass spectrometry, glycans and biophysical characterization. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

NUVISAN

NUVISAN offers Large-molecule QC testing, bioanalysis and clinical biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Selvita

Selvita offers Biologics characterization, analytical development and quality control. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Emery Pharma

Emery Pharma offers Biologics mass spectrometry, NMR, structural characterization and impurities. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Avance Biosciences

Avance Biosciences offers Biologics and gene-therapy analytical testing, potency and molecular assays. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Texcell

Texcell offers Biosafety, cell-bank characterization and bioassays. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Clean Cells

Clean Cells offers Biologics potency, biosafety and cell-bank characterization. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Merck BioReliance

Merck BioReliance offers Biologics biosafety, cell-bank characterization and GMP testing. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

KABS Pharmaceutical Services

KABS Pharmaceutical Services offers Analytical development, validation and quality control for biopharmaceuticals. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Custom Biologics

Custom Biologics offers Biologics potency, functional assays, PK and immunogenicity. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Rapid Novor

Rapid Novor offers Antibody sequencing, mass spectrometry and characterization. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

BIOVECTRA

BIOVECTRA offers Biologics analytical development, characterization and GMP testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Biodextris

Biodextris offers Vaccine and biologics analytical development, validation and quality testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

WuXi Biologics

WuXi Biologics offers Biologics structure, higher-order structure, potency, release and stability. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Pharmaron

Pharmaron offers Biologics characterization, PK/TK, immunogenicity and biomarkers. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

UP Pharma

军科正源 (UP Pharma) offers Protein characterization, PK, ADA, neutralizing antibodies and biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Biotree

百趣生物 (Biotree) offers Protein characterization, developability and multiomics biomarkers. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Yaohai Bio-Pharma

耀海生物 (Yaohai Bio-Pharma) offers Recombinant proteins, nanobodies and nucleic-acid characterization and QC. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

BioDlink

东曜药业 (BioDlink) offers Antibody and ADC characterization, higher-order structure and comparability. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

MabPlex

迈百瑞 (MabPlex) offers Antibody and ADC structure, potency, impurities and CMC analytics. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Chime Biologics

鼎康生物 (Chime Biologics) offers Biologics analytical development, characterization, release and stability. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

ProBio

ProBio offers Antibody and gene-therapy characterization, bioassays and quality control. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Samsung Biologics

Samsung Biologics offers Biologics identity, purity, potency, release and stability testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

LOTTE Biologics

LOTTE Biologics offers Biologics method transfer, potency, release and stability testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

BINEX

BINEX offers Biologics analytical development, validation and protein characterization. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

Prestige Biologics

Prestige Biologics offers Biologics analytical testing and analytical development within CDMO services. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

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SERVICE PROVIDER

Lonza

Lonza offers Biologics analytical development, characterization and GMP testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

AGC Biologics

AGC Biologics offers Protein and cell/gene-therapy analytical development and quality testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

KBI Biopharma

KBI Biopharma offers Biologics structure, biophysical characterization, potency and analytics. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

Abzena

Abzena offers Antibody and bioconjugate characterization and analytical development. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

Curia

Curia offers Biologics analytical testing, bioassays and stability. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

FUJIFILM Biotechnologies

FUJIFILM Biotechnologies offers Biologics biochemical and biophysical characterization, potency and GMP testing. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

Northway Biotech

Northway Biotech offers Biologics analytical development, characterization and quality control. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

Aragen Life Sciences

Aragen Life Sciences offers Protein characterization, analytical development and clinical bioanalysis. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

Syngene International

Syngene International offers Biologics characterization, regulated bioanalysis and clinical biomarkers. This is the analytical service business of an integrated CRO/CDMO.

Sources checked: 2026-11-05

Profile & sources →
SERVICE PROVIDER

VelaLabs

VelaLabs offers Biologics characterization, GMP QC, potency and clinical bioanalysis. Services should be matched to the intended study and assay requirements.

Sources checked: 2026-11-05

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Selected publications & research guides

Original online dates are retained. Guides use accessible articles or abstracts and do not replace reading the paper.

Export RIS citations ↓
mAbs · Perspective

Setting expectations for current and future directions of native mass spectrometry in the biopharmaceutical industry

This industry perspective examines native mass spectrometry as a complement to established biopharmaceutical characterization methods. It discusses intact assemblies, binding, stoichiometry, and heterogeneity, while identifying throughput, sensitivity, automation, and access limitations. The authors emphasize integration with analytical workflows rather than universal replacement of existing methods.

Elizabeth Hecht; Esther Martin; Idlir Liko; Andrew Mahan; Aniruddha Sahasrabuddhe; Nastaran N Tajoddin; Iain D G Campuzano
DOI: 10.1080/19420862.2026.2699078

Original paper ↗

Dated source notes

Manually selected historical and recent original announcements, not presented as today’s news. Source dates, including historical dates, are retained.

BioAgilytix

BioAgilytix reports progress following its GMP analytical expansion

BioAgilytix reviewed its earlier analytical investment in Morrisville and Hamburg, describing infrastructure for GMP QC, characterization, bioassays, release, and stability programs. This is a May 2026 company update about previously expanded capabilities, not a newly announced November facility opening or independent quality certification.

Original announcement ↗
AI assistant ↗