Biological Macromolecule Drug Testing Service

Leveraging years of expertise and technological accumulation in small molecule and emerging modality drug development, our Analytical Service Platform has established a comprehensive system for macromolecular structure characterization service. Supported by specialized expertise and cutting-edge platforms, this system provides end-to-end support for new drug development—from molecular design to structural characterization—helping clients accelerate their drug development programs with efficiency and confidence.

Analytical Characterization
and Quality Studies		 Quality Attribute Inspection Item Name Analytical Instrument
Structural Characterization Protein primary structure Full Molecular Weight High-Performance Liquid Chromatography-Mass Spectrometry：
Thermo Vanquish Q Exactive
Reduced Molecular Weight
Deglycosylated Molecular Weight (Full and Reduced)
Sequence Coverage
Mass Peptide Map
ADC Conjugation Site Analysis
DAR Value Analysis
Disulfide Bond Pairing
N/C-Terminal Sequence Analysis
N/O-Glycosylation Site Analysis
N-Glycosylation Pattern Identification
Post-Translational Modifications (Including Q-Looping, Deamidation, Oxidation, C-Terminal Modifications, Glycosylation, etc.)
Impurity Research Process-related impurities TCEP Residues High-Performance Liquid Chromatograph
Residual Solvent (DMSO) Gas Chromatograph Agilent 8890
Product-related impurities Free Drug and Related Impurities High-Performance Liquid Chromatograph
Unconjugated Protein High-Performance Liquid Chromatograph/ICIEF
Physical and Chemical Properties General Examination Water Content Mettler C30S
Resuspension Time /
Raman Spectra Thermo TruScanTM RM
Identification Isoelectric Point Protein simple Maurice
Peptide Map Ultra-High Performance Liquid Chromatography System
Potency DAR Value (HIC) High Performance Liquid Chromatography System
DAR Value (RP) High Performance Liquid Chromatography System
Relative Binding Activity Elisa
Charge Heterogeneity CEX-HPLC High Performance Liquid Chromatography System
icIEF Protein simple Maurice
Molecular Size Heterogeneity SEC-HPLC High Performance Liquid Chromatography System
CE-SDS(R or NR) SCIEX PA800 Plus
Physicochemical Analysis Tween 20/80 Content High Performance Liquid Chromatography System
Glycosylation pattern Ultra-High Performance Liquid Chromatography System
Amino acid composition High Performance Liquid Chromatography System
Extinction coefficient High Performance Liquid Chromatography System
Free sulfhydryl groups MD ID5
Higher Structure Infrared spectroscopy Thermo Nicolet Summit X
DSC MicroCal PEAQ
Intrinsic fluorescence MD ID5
CD Circular Dichroism
Microbiological Testing Safety Bacterial Endotoxins Lonza Elx808
Microbial Limits Merck MXPPLUS02
Sterility Testing PSI-LPG4
Seal Integrity Testing MD-750

Project Example

Molecular Weight Analysis of the Monoclonal Antibody Herceptin

The high-resolution mass spectrometer Q Exactive Orbitrap was used to capture multi-charge signals of the antibody. Deconvolution analysis using BioPharma Finder software yield accurate molecular weight values, enabling preliminary assessment of glycan modifications and other structure features.

TIC Total Ion

Original Score：m/z400~4000

Convolutional Decoding Sequence

ADC Peptide Mapping

Following digestion with one to three enzymes, the ADC protein drug is subjected to mass spectrometric analysis to collect primary mass spectrometry information of peptide segments and secondary mass spectrometry information of fragment ion. BioPharma Finder software was used to analyze the total ion current spectrum, matching observed peptides masses to theoretical values, and confirm light- and heavy- chain sequences through secondary mass spectrometry information of fragment ion. Peptide coverage is calculated based on the ratio of amino acid sequences in confirmed peptides to their theoretical sequences.

BPC profile of HC after trypsin digestion

BPC spectrum of LC after trypsin digestion

ADC Sequence Coverage (Trypsin Single-Enzyme Digestion Results)

Our Service Offers

Service Consultations

Analytical testing services require evaluation before determining the appropriate plan and pricing. For further information on service pricing or technical details, please email [email protected] or contact MCE’s sales representatives directly.

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