三華生技抗體藥物分析與製程開發實驗室

抗體藥物開發與製程生產

抗體藥物分析服務

三華建立了完善的抗體藥物分析平台,確保標的都能夠被深入評估。包括了純度/不純物分析、胺基酸序列鑑定、結構特性分析、物化性質分析等。全方位觀察藥物的各個面相,從日積月累的經驗中,我們的專業分析團隊亦能針對各式不同的生物製劑,開發出客製化的分析方法

分析項目包含:

  • 抗體純度分析
    • SEC-HPLC
    • High / Low Molecular Weight Species (HMW/LMW)
    • Monomer Content
    • Light / Heavy Chain Identification
  • 精確分子量鑑定
    • Intact Protein Mass Analysis
    • Major Glycoform Profiling (e.g., G0F / G1F / G2F)
    • C-terminal Lysine Heterogeneity
  • 轉譯後修飾分析
    • PTM Profiling
    • Disulfide Bond Mapping
  • 電荷異質性分析
    • Cation Exchange Chromatography (CIEX-HPLC)
    • Acidic / Basic Isoform Profiling
  • 胜肽序列鑑定
    • 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

抗體製程開發Antibody Process Development

我們提供一站式抗體產製服務,涵蓋從穩定細胞株建構、製程開發到小規模生產的全方位流程。憑藉內部先進的設備與嚴格的品質控管(QC),我們致力於交付高品質的客製化抗體,以滿足多樣化的研發需求。

《抗體製程開發流程》

1. 細胞株開發 (Cell Line Development, CLD)

Cloning & Vector Construction

Cell Expansion

Stable Cell Line Screening

Cell Banking (MCB/WCB)

2. 製程開發與生產 | 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