―　All types of low to high molecular compounds are analyzable.

§ GLP bioanalysis of bioproducts in compliance with ICH-Q6B guidelines

　  Recombinant proteins, monoclonal antibodies, antibody-drug-conjugates(ADC), vaccines, peptides, glycoproteins, etc.

●  Analytical methods

- molecular weight and amino acid sequence

- glycan structure and profiling

-  disulfide bond

-  peptide mapping

●  Equivalency/equality and biosimilarity evaluation●  PK/PD studies(LS-MS, ELISA)

● Process- or final product-related impurities impurities(purity determination)

-  truncated forms

-  post translation modification

-  host cell-related proteins

●  Discovery and verification of biomarkers

●  Proteomics analysis

●  Method development

§ Pharmacodynamic, DMPK and bioanalytical services of chemical drugs

　CRO companies provide various biological testing services at all stages of preclinical, clinical and post marketing studies for not only biological pharmaceuticals, but also of low molecular pharmaceuticals. 

● Bioequivalency and bioavailability

●  PK studies in preclinical and clinical studies

●  Development and validation of LC-MS/MS, UPLC-MS, ICP-MS and ELISA bioanalytical methods

●   In vitro metabolism

●  Pharmacodynamics studies

●    Evaluation in bridging studies

From the many clients who have utilized our services, we have earned a solid reputation as being both reliable and competitively priced.

Once the details of a contract have been established, we will inform you of the standard price (Price List). Please contact us through the "Inquiry Page".