Biologics - Protein Drug Analysis

Booth No: N/A

Characteristic

Mithra offers full characterization plans in accordance with ICH Q6B to assist biopharmaceutical development from discovery, CMC preparation, registrations, manufacturing to clinical levels.

Biopharmaceutical analysis services:
1. Primary structural characterization and physicochemical property
2. Biosimilarity and comparability study
3. Protein research and customized methoddevelopment
4. Post-translational modification
5. Biomarker analysis
6. Glycan analysis
7. Protein quantification
8. Protein drug analysis (mAb，ADCs，Peptide，Hormones)

Instrument:
Quadrupole-Orbitrap Mass Spectrometer
 Thermo Scientific Q Exactive

Quality certificate:
USFDA Good Manufacturing Practice (GMP) inspection in 2017.
(No observation)