Mithra Biotechnology Inc., the first Contract Research Organization (CRO) in Taiwan since 1988 offers integrated and multi-dimensional CRO services including full characterization plans for biologics in accordance with ICH Q6B and bioanalytical services for chemical drugs and biologics to assist pharmaceutical development from discovery, CMC preparation, registrations, manufacturing to clinical levels.
With profound expertise in biological products diverse in monoclonal antibodies, growth factors, antibody drug conjugates (ADC) and other various proteins, the company’s services include primary structure characterization, terminal sequencing, PTMs identification, disulfide bond assignment, carbohydrate structure analysis and peptide mapping for biosimilar comparison or lot-to-lot QC, and degradation/impurities profiling.
The company has proven expertise and experience in meeting international standards to serve the fast growing pharmaceutical industry, as evident from the accredited GLP compliance laboratory working on both small molecule drugs and proteomics. The laboratory is equipped with state-of-the-art analytical instruments including UPLC-MS/MS, LC-MS/MS, nanoflow LC-HRMS, ICP-MS and ELISA systems for sensitive and high throughput drug quantification in various biological matrices.
A great variety of comprehensive methods have been developed and validated for contract research, as well as SOPs been established and applied to ensure the result been delivered to its highest quality