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Bioanalytical Services

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.