中文

Analytical Methods
Physicochemical Analytical Development
Canton Biologics' Physicochemical Analysis Platform is equipped with fully compliant, comprehensive, and high-performanceinstrumentation, supported by an experienced analytical method development team and a robust quality management systemThrough digitally integrated systems such as CDAP, RA and ELN, we implement end -to end control throughout the methoddevelopment and validation lifecycle, providing clients with high-quality CMC and regulatory submission support

In recent years, we have successfully supported over 21 projects in their IND/BLA filings including monoclonalantibodies (mAbs), bispecific antibodies (BsAbs) recombinant proteins, fusion proteins, and recombinant vaccines
Compliant Analytical Services
・We adhere to ICH and global regulatory guidelines toestablish a comprehensive product quality analysisand specification library.
Diverse Project Portfolio
・Integrated CMC studies/Targeted physicochemicalcharacterization/Stand-alone testing services
Comprehensive & Rapid Method Development
・Early-stage molecule screeningUpstream/downstream process intermediatesDrug substance, drug product, and stability studies
Proven Regulatory Expertise
・We deliver detailed method development/validation reports,characterization data, and CTD documentation compliantwith China NMPA and US FDA submission requirements.
Charge Variant Analysis (iclEF)
We possess extensive method development experience,capable of performing charge heterogeneity analysis forvarious complex proteins, delivering accurate, rapid, andhighly reproducible analytical solutions.

icIEF分析双特异性抗体的电荷变异体

Rapid Peptide Mapping
By integrating expertise across diverse protein types and characteristics, we haveestablished an end-to-end peptide mapping workflow that reduces method

In-silico
Analysis

CDR or Signature Sequence
Annotation

LC-MS
MDR

LC-MS Method Development

Method
Pre-validation

Transfer to Physicochemic
alnalysis Group

Method Development
Report (MDR)

Finalize Method
Development Tasks
Peptide Mapping Method Development
Method Validation
Characterization Analytical Development
Canton Biologics Characterization Platform is equipped with high-resolution mass spectrometry systems including WatersAcquity H-Class & Xevo G2-XS and Thermo Vanquish & Q Exactive Plus, supported by bioinformatics software suites suchas UNIFl, Xcalibur, Mass Frontier, Biopharma Finder, pGlyco, pLink, Mass Solver, and Glycoform Searching. This integratedplatform provides comprehensive characterization services to support process development and quality studies for variousbiomolecules.
Amino Acid Sequence Analysis
Risk Attribute Prediction
2D and 3D
Structure Constructior
Mechanism of Action
Risk
Assessment
Project
References
01
In-silico Analysis
By leveraging bioinformatics tools, we rapidly obtainphysicochemical properties of proteins-including molecularweight, isoelectric point, extinction coefficient, disulfidebonds, free thiols, and glycosylation-while predictingpotential post-translational modifications, aggregationpropensity, and immunogenicity.
Through 3D visualization and platform experience, wegenerate developability assessment parameters to supportclients in early CMC stages for molecule optimization,upstream/downstream process and formulation development,and early risk mitigation strategies-ensuring successful CMCdevelopment within reasonable timelines and costs.
02
N/O-Glycan Characterization
By integrating in-silico predictions with experimental data-including intact protein mass, free glycans, sialic acidprofiling, and glycopeptide analysis-we provide acomprehensive orthogonal analysis of protein glycosylation.This approach delivers critical glycosylation-specific qualityattributes (gcQAs) to support clone screening, culturecondition optimization, and downstream purification,ultimately accelerating biopharmaceutical development whileenhancing product efficacy and safety. Service PortfolioIncludes:
Service Portfolio Includes:
・Service Portfolio Includes:
・Content Analysis of Critical GlycanTypes: Sialylation, fucosylation, high-mannose, terminal galactosylation, and Gal a1-3 Gal
・N/O-glycosylation Site Identification
・N-glycosylation SiteOccupancy Analysis & Site-Specific GlycoformProfiling

复杂游离N-糖谱鉴定图谱(HILIC-FLR-MS)

03
Peptide Mapping and Post-TranslationalModification (PTM) Analysis
We employ well-established top-down, middle-down, andbottom-up strategies to characterize diverse PTMs fromeukaryotic, E. coli, and yeast fermentation systems. Custommethod development is available to meet specific clientrequirements.

Sequence Coverage

Post-Translational Modifications (PTMs)

N-/C-Terminal Sequence Confirmation

Sequence Variant Analysis

Cleavage Site Analysis

Site-Specific Glycosylation Analysis

04
Higher-Order Structure(HOS)Analysis
Higher-Order Structure (HOS) characterization elucidates thesecondary, tertiary, and quaternary structures of biologicmacromolecules. Integrated with primary sequence analysis, itensures structural consistency across batches. This approach iswidely applied in site transfers, process scale-up/scale-down,manufacturing changes, and comparability studies, supporting bothproduct development and regulatory submissions.

Techniques Include:

Circular Dichroism (Far-UV/Near-UV CD)

Differential Scanning Calorimetry (DSC)

Fluorescence Spectroscopy

Size-Exclusion Chromatography with Multi-Angle Light

Scattering (SEC-MALS)

Analytical Ultracentrifugation (AUC)

Dynamic Light Scattering (DLS)

Micro-Flow Imaging (MFI)

Biochemical Analysis Platform
Bioanalysis is integral throughout all stages of drug development, including candidate screening, mechanism ofaction characterization, safety assessment as well as potency, stability and comparability studies duringmanufacturing. Canton Biologics has extensive expertise in functional and potency bioassays for a variety ofbiotherapeutic modalities-Such as antibodies, vaccines ADCs, and fusion proteinsdelivering comprehensivebioanalytical services to our clients.Our team possesses substantial project experience in cell-based activity assays, selecting relevant target oreffector cells based on the specific drug's mechanism of action and developing corresponding cell-based potencymethods. We offer a range of bioanalytical approaches, including assessment of target-effector cell binding, signaltransduction, cell proliferation, cytotoxicity, viral neutralization, cytokine release, and other immune functionanalysesAdditionally, we provide custom assay development and validation-including reporter cell line engineering-tosupport feasibility studies, IND submissions, non-clinical and clinical studies. All services are performed incompliance with current bioanalytical guidelines from NMPA, ICH, FDA, and EMA, ensuring high-quality data toadvance our clients' programs.
Core Services

Project Consulting Services

Custom Assay Development

Method Transfer to QC or Third-Party

ELISA Kit Development

Reporter Cell Line Development

Release Assay Development

Core Technology

Comprehensive ELISA Analysis

SPR/BLI Affinity Analysis

In Vitro Bioactivity Analysis

Multicolor Flow Cytometry Analysis

Early-Stage Molecular Screening

Exosome Analysis

State-of-the-art and fully-equipped instrumentation
Bioassay capability

Bioassay capability

ELISA binding potency

ELISA competitive binding

ELISA titer

ELISA kit construction

Cell-based potency

Reporter gene assay

Cell cytotoxicity

Cell proliferation

ADCC/ADCP/CDC

Cytokine release

Enzymatic activity

Virus neutralization

Affinity analysis

SPR/BLI

Affinity screening

Epitope screening

Gene analysis

ddPCR/qPCR) c/gDNA analysis

Mycoplasma

Residual analysis

Host cell protein

Host cell DNA

Protein A

FVIISelect

Insulin

Ampicillin

Dnase/RNase

Other analysis

Coagulation Activity

Fibrinolytic Activity

Western Blot

Endotoxin

Reporter Gene Cell Line Construction
Genetic engineering is used to create reporter cell lines, overcoming the limitations of traditional primary cells and enablingadvances in cell-based activity analysis. These lines are designed based on the drug's mechanism of action (MOA) andmonitor target signaling by measuring reporter gene expression, offering high sensitivity, fast turnaround, highreproducibility, and easy operation.
Cantonbio has established an efficient reporter cell platform to support drug development. It meets the needs of signalingresearch and early-stage screening, and also supports CMC release through functional and stability validation.
Service Workflow
Project Design 1-2 Weeks

Design reporter cellline constructionplan based on theproduct MOA andclient requirements.

Vector
Construction 1-2 Weeks

Construct high-efficiency expressionvectors containing thetarget gene andreportergene.

Cell Transfection 1-2 Weeks

Chemical

Electroporation

Lentiviral

Selection and
Characterization 1-2 Weeks

Confirm gene expression

Validate reporter genefunction

If Monoclonal Cell Lines Are Required

Monoclonal Cell Line Screening

3-5 Weeks

Single-cell seeding

Monoclonal gene expression verification

Monoclonal functional validation

Passage Stability Study

7-8 Weeks

Functional testing ofmonoclonal cells atdifferent passages

Gene expression testing ofmonoclonal cells atdifferent passages

Product Delivery

1 Week

Stable monoclonal cell line

Product quality test report(CoA)

Cell line construction report

Platform Advantages
Designed based on product MOA to meet client needs
Short assay cycle, simple operation, and high reproducibility
Wide response window and high sensitivity
Supports stability and passage studies for method validation
Complementary reporter gene assay development services
Comprehensive R&D platform with extensive project experience.
Developable Cell Types

Cell Type

Product Name

Application

ADCC & ADCP ADCC Reporter Jurkat (158V)

Detection of Antibody ADCC Effect

ADCP Reporter Jurkat (131H)

Detection of Antibody ADCP Effect

Target and Pathway Research

NF-κB Reporter 293T

Development of NF-κB Pathway Activators or Inhibitors  

TLR4 Reporter 293T

Screening of Functional TLR4 Antibodies / Ligands 

STAT3 Reporter DH82

Development and Screening of STAT3 Pathway Activators or Inhibitors

Viral Drug Research

Universal Virus-inducible Reporter Cell

Detection of Antiviral Drug Activity  

Overexpressing Cells 

Canine IL-31R overexpressing 293T

Development and Screening of Canine-Derived IL-31 Receptor Antibodies or Canine-Derived IL-31 Blocking Antibodies

Analytical Service Menu

Category

Testing / Method Development Item

Analytical Method

Protein Content 

UV280/SoloVPE
BCA/Bradford/SDS-PAGE
RP-HLPC/SEC-HPLC/Protein A

Identity

Isoelectric Point

icIEF

Peptide Mapping

RP-HPLC/UPLC

Western Blot

Western Blot

Biological Activity

Binding Activity

ELISA

Cell-Based Activity

MoA-based

Primary Structure

Mass Spectrometry Molecular Weight

 

Intact Mass

Reduced Mass

Deglycosylated Intact Mass

Deglycosylated Reduced Mass

Sequence Coverage

Multi-Enzymatic LC-MS Peptide Mapping

Post-Translational Modifications

LC-MS Peptide Mapping

N-Terminal / C-Terminal Sequence Analysis

LC-MS Peptide Mapping

Video