Quality study

Development and validation of individual analysis methods

Study on drug quality standards

Stability study

Analysis of elemental impurities, genotoxic impurities, etc

Writing of application materials

Impurity identification and analysis (accurate molecular weight determination and structural formula analysis by QE-HF)

Structural characterization of biological products

Determination of protein molecular weight

Peptide map analysis (peptide segment coverage analysis, amino acid sequence analysis, N-terminal C-terminal integrity analysis, N-sugar and modification analysis)

Disulfide bond pairing analysis

Physical and chemical analysis of biological products

Development and validation of individual analytical methods (IEC/SEC/RP/HIC and other customized services)

Study on drug quality standards

Writing of application materials

Identification and analysis of impurities in biological products

Amino acid sequence and modification analysis of polypeptide impurity

Host protein residue analysis (HCP) by mass spectrometry