Biopharmaceutical Impurities Analysis Service

• • Metal Content Analysis Service

  Metal content analysis is a technique for detecting and quantifying concentration of metal elements in samples, crucial for ensuring the efficacy and safety of bioproducts during their development and manufacturing. Common methods include atomic absorption spectroscopy (AAS), X-ray fluorescence (XRF), and inductively coupled plasma mass spectrometry (ICP-MS). AAS, a straightforward and cost-effective method, analyzes metal content by combusting the sample and measuring the absorbance of specific elements

• • Protein Content Analysis Service

  The analysis of protein content in bioproducts is a principal method for assessing bioproduct quality and constitutes a significant aspect of bioproduct quality standards. Typically, the analysis employs chemical or physical methods, including titration, spectroscopy, and chromatography. Titration offers simplicity and accuracy. Spectroscopy provides rapidity and high sensitivity. Chromatography excels in both sensitivity and specificity.

• • Host Cell Protein (HCP) Analysis Service

  MtoZ Biolabs uses 2D DIGE and Western blot technology for HCP analysis.

• • Native Mass Spectrometry Analysis Service

  Native mass spectrometry (Native MS) facilitates direct determination of a protein's molecular weight. It facilitates the study of intact proteins, non-covalent protein-protein interactions, and protein-ligand complexes within biological systems, addressing the limitations of traditional mass spectrometry technologies in the precise quantification of complex drug molecules.

• • SDS-PAGE Based Protein Purity Analysis Service

  MtoZ Biolabs has developed and optimized a SDS-PAGE based workflow, and provides an accurate analytical service for protein/peptide purification study.

• • SEC and RPLC Based Protein Purity Analysis Service

  MtoZ Biolabs has established a platform with both SEC and RPLC technologies, to meet the requirements of analyzing various biopharmaceutical samples.