三華生技抗體藥物分析與製程開發實驗室

Antibody Analytical Services & Process Development

Antibody Analytical Services

TMT has established a comprehensive analytical platform for antibody drugs to ensure every target is thoroughly evaluated. Our capabilities include purity/impurity analysis, amino acid sequencing, structural characterization, and physicochemical property assessment. With extensive experience, our expert analytical team also provides customized method development tailored to various types of biologics.

Analytical Capabilities:

  • Antibody Purity Analysis
    • SEC-HPLC
    • High / Low Molecular Weight Species (HMW/LMW)
    • Monomer Content
    • Light / Heavy Chain Identification
  • Intact Mass & Variant Characterization
    • Intact Protein Mass Analysis
    • Major Glycoform Profiling (e.g., G0F / G1F / G2F)
    • C-terminal Lysine Heterogeneity
  • Post-Translational Modification (PTM) Analysis
    • PTM Profiling
    • Disulfide Bond Mapping
  • Charge Heterogeneity Analysis
    • Cation Exchange Chromatography (CIEX-HPLC)
    • Acidic / Basic Isoform Profiling
  • Peptide Mapping & Sequencing
    • Amino Acid Sequence Verification
    • Peptide Mapping (LC-MS/MS)

Antibody purity analysis

SEC-HPLC
High / Low molecular weight species
Monomer
Light /Heavy chain

Intact Mass Analysis

Intact protein mass
Major glycoform
G0F / G1F / G2F
C-terminal lysine

三華生技抗體藥物分析與製程開發實驗室

PTM Analysis

PTM Analysis

PTM profile
Disulfide bonds

Charge Heterogeneity Analysis

CIEX-HPLC
Acidic / Basic Isoforms

Peptide Mapping

Amino acid sequence
Peptide map

Antibody Process Development

We provide a one-stop solution for antibody production, covering the entire workflow from stable cell line construction and process development to small-scale manufacturing. Leveraging our advanced in-house equipment and rigorous Quality Control (QC), we deliver high-quality, customized antibodies to meet diverse R&D requirements.

Our Workflow:

1. Cell Line Development (CLD)

Cloning & Vector Construction

Cell Expansion

Stable Cell Line Screening

Cell Banking (MCB/WCB)

2. Process Development & Production

Working Cell Bank (WCB)

Seed Train

Production Bioreactor

Harvest (Centrifugation or Depth Filtration)

Capture / Primary Purification (Protein A Affinity Chromatography)

Polishing / Secondary Purification (IEX Chromatography & Virus Filtration)

Concentration & Formulation (TFF System)

Drug Substance (DS)

Sterile Filtration, Fill & Finish, and Labeling

Analytical Characterization & Batch Release Testing