Characterization and Bioanalysis of Biotherapeutic Large Molecules
Biologics, such as monoclonal antibodies, is the emerging area of new drug development, and its future is promising.
Structural characterization of protein drugs by LC-MS technology may provide extensive sequential structure information,
and also quantitative results with extremely high selectivity and specificity that traditional approaches,
such as, immunoassay are unreachable. Large molecules LC-MS technology is our unique and key value,
with which we are able to service our clients’ challenging projects in large molecules characterization and bioanalysis,
providing unmatchable results:
Structure Characterization of Protein Drugs
High Selective Protein Drug Bioanalysis
Small Molecules Bioanalysis
SSR MedTech has very experienced bioanalytical team,
and is capable of providing LC-MS bioanalytical solutions for clients’most challenging projects to support generic drugs
BE clinical studies and new drug development in every stage of preclinical and clinical trials.
Being confident with possessing the first-class technologies and platforms, strict quality management,
SSR MedTech can provide the following services timely and efficiently to our clients:
Lc-ms Method Development / Validation / Transfer and Optimization
Bioanalysis of Be Clinical Samples
Tk/Pk In Pre-clinical Phase or Bioanalysis for Drug Development
Drug Metabolite Evaluation
Evaluation of drug metabolite has significant impact on drug safety and toxicity, and is one of keys for success in drug development.
According to FDA guidance, the safety assessment should be conducted if a drug metabolite is 10% more of the total drug content.
However, the qualitive and quantitative evaluation of a metabolite is a challenging task to analytical chemistry.
Relying on its deep knowledgeable technical staff, and suitable instrumentation,
SSR MedTech is able to provide our clients the following services:
Identification of Metabolite and Metabolite Profiling
Identification of Metabolic Pathway
Plasma Protein Binding
Bioanalysis of Pharmacodynamics (PD) Biomarkers
PD biomarker has become an important means to evaluate drug efficacy. As endogenous molecules, bioanalysis for PD
biomarker is characteristically different from the approach for exogenous drugs.
SSR MedTech provides routine biomarker bioanalysis, and also cable of developing bioanalytical methods for new
biomarkers to meet clients’ specific needs in drug development.
Small Molecule Biomarkers
Testing of Biomarkers in Clinical Diagnosis, Precision Medicine and Functional Medicine
Testing of Hormone
New Born Screening
Treatment Drug Monitoring
Amino Acids Testing/Profiling
Testing of Vitamins (A, B, C, D, E)
Testing of Peptides and Proteins