【Introduction of CROs】

In addition to various CRO services, including bioanalysis under ICH Q6B guideline, our partner CROs also provide bioanalytical services for discovery & development, registration, production and clinical trials of synthetic or biological pharmaceuticals. These services are done in laboratories approved by the USFDA, PMDA, TFDA, OECD and NPRA audit.

 

 

【Bioanalytical Services of Biological and Low Molecular Drugs 】

 

　Analytical services by LC-MS/MS in biological drug R&D

 

In the analysis of proteins, very high degree of skill and experience are required due to the complexity of physicochemical properties of protein products.  Our CRO partners provide the following broad analytical services using the most advanced technologies:

 

・structural characteristics

 

・structure identification

 

・analysis of physicochemical properties

 

・impurity identification during the production process and of final products

 

・biomarker analysis in preclinical and clinical studies

　

 

　GLP bioanalytical services in compliance with ICH Q6B guidelines

 

We provide analytical services for amino acid sequencing, peptide mapping, S-S bond, sugar chain structure, molecular weight and PTMs under GLP conditions.  Based on client needs, the R&D services team of CRO partners establishes a proper analytical method and appropriate protocols for CMC preparation.  These CROs also conduct analytical assays for non-GLP studies under GLP-like conditions.

 

 

 

　Pharmacokinetic and pharmacodynamic assays

 

Scientists, having extensive experience conducting PK/PD assays, provide professional evaluation or consultation according to required regulations for the following studies:

 

・analysis in bridging study

 

・PK/PD assays in preclinical study

 

・toxicokinetic study

 

・PK/PD assay in clinical study

 

・bioavailability (BA) or bioequivalency(BE) study

 

・PK/PD assay after NDA

 

 

 

　Bioanalytical services under GLP guidelines(low molecular compound)

 

The laboratories of our CRO partners, which are compliant with GLP guidelines, provide the following services.  If required, the assays under light-shading condition are possible.

 

・analytical method development and measurement

 

・bioanalysis of original drug and its metabolites,

 

　・Elemental analysis (Ca, Fe, Mg, Pt, etc.)

 

 

【Analytical Services of Biological Products】

 

　　Analysis in drug development using LC-MS/MS

 

mAb, ADC, peptides, glycoproteins, recombinant proteins, vaccines, etc.

 

　　　　　・identification of total amino acid sequence

 

　　　　　・equivalency of biosimilars

 

　　　　　・identification of impurities

 

　　　　　・lot release assay

 

　　　　　・production optimization

 

　　　　　・stability assay

 

 

　　ICH Q6B-compliant GLP bioanalysis

 

　　　　　Physicochemical properties

 

　　　　　・molecular weight, molecular size

 

　　　　　・amino acid sequence

 

　　　　　・sequence of terminals

 

　　　　　・peptide mapping

 

　　　　　・S-S bond

 

　　　　　・sugar chain structure

 

　　　　　Production process- or product-related impurities

 

　　　　　・truncated forms

 

　　　　　・post translation modification

 

　　　　　・host cell originated protein

 

 

 

　　Assay development

 

　　　　　・ELISA assay

 

　　　　　・bioavailability(BA)/bioequivalency (BE)/PK assays

 

　　　　　・biomarker detection and its verification

 

Our specialists will consult with you to meet your needs.