【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:
・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
・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
ICH Q6B-compliant GLP bioanalysis
・molecular weight, molecular size
・amino acid sequence
・sequence of terminals
・sugar chain structure
Production process- or product-related impurities
・post translation modification
・host cell originated protein
・bioavailability(BA)/bioequivalency (BE)/PK assays
・biomarker detection and its verification
Our specialists will consult with you to
meet your needs.