Analytical Testing Platform

Reference: tjab Time:2016-09-29 16:08

The Testing Center of TJAB is the National Biological and Medicinal Public Service Platform founded by the MOST, MOFCOM, NHFPC, CFDA and the Tianjin Municipal Government, with independent legal entity, independent accounting and entrepreneurial administration and operation system. We have established an impeccable quality control system in compliance with ISO IEC17025 standard and our report is recognized by over 64 economies and 74 international certification bodies in the world. We provide a full range of professional testing service in area of drug, food, healthcare, cosmetics, environment and water quality.


The testing center occupies approximately 2,800 square meters of lab space in the lab building of TJAB, with over 250 instruments and housing state-of-the-art instruments and equipments up to 40 million RMB investments. 


Our instruments:

400/600M NMR,HRMS, Triple Quadrupole TandemLC-MS-MS System, LTQ, GC, GC-MS, HPLC, ICP-MS, Organic Elemental Analysis, IR, DVS, INVIVO IMAGING SYSTEM IVIS Spectrum, 2-D Gel Electrophoresis and FCM, etc. 



Our services:

I. Drug Metabolism and Pharmacokinetics (DMPK)

● DMPK in vivo

Clinical Bioanalysis (BE & BA study)

Pharmacokinetic experiments with animals of different species (e.g. rat, mouse, dog, monkey and rabbit, etc.)

DMPK experiments via various routes of administration (e.g. IV, IG, IH, IP, etc.)

Drug distribution in tissues

Metabolite profiling and identification

● DMPK in vitro

Plasma protein binding

Plasma stability

Permeability of drugs

Liver microsome/S9/hepatocyte stability

CYP phemotyping

Metabolite profiling and identification

Drug-drug interaction



II. Proteomics and Molecular Biology service

● Proteomics

Protein identification and quantification of biological samples such as animal tissues, plasma, fungi, bacteria and plant tissues. Using 2D gel-LC-MS/MS or label free proteomics based on 2D LC-MS/MS to develop potential biomarkers.

● Protein structure analysis

Protein and peptides sequencing, Protein molecular weight measurement, 

C terminal sequencing, Protein purity, Peptide fingerprinting, Disulfide bonds identification, Identification of protein phosphorylation, Protein Isoelectric Point measurement, SDS-PAGE, Tricince SDS-PAGE.

● Macromolecules interactions (Biacore)

Kinetic and Affinity analysis of antigen-antibody, protein-protein, protein-small organic molecules.

● Molecular Biology service

DNA, RNA extraction, recycling, purification; PCR, RT-PCR, qPCR; Gene Cloning etc. 

III. Pre-clinical Pharmaceutical Research

● Organic structure analysis

NMR: 1H-NMR; 13C-NMR; DEPT; Heteronuclear NMR including17O, 31P, 19F, etc.; 1D NMR such as 1D-NOE; Homonuclear through-bond correlation methods including H-H COSY, NOESY, ROSEY, TOCSY, J-resolved; Heteronuclear through-bond correlation methods including HMQC, HSQC, HMBC, J-filter HMBC

Mass spectrometry; IR spectroscopy; Organic elemental analysis; DSC and TGA; UV spectroscopy and X-ray crystallography



● Physicochemical properties analysis

Including measurements of optical rotation, melting point, crystal form, polycrystallinity, absorption coefficient, pKa and solubility, etc.

● Quality control and stability study

Related substances study, including impurity preparation and structure analysis;

Residual solvent examination;

Residual heavy metal examination;

Chinese traditional medicine fingerprinting;

Establishment and validation of content determination methods;

Stability studies;

Document writing for registration and declaration

● One-site service for Drug R&D

For Chemical drugs: From project approval, synthesis process and establishment of quality standard, drug stability research, documentation, until declaration.

For Chinese Traditional Medicine/Natural Products: From extraction process, preparation process, and establishment of quality standard, drug stability research, documentation, until declaration.


 

● Quality Consistency Evaluation for Generic Drugs

In vivo Quality Consistency Evaluation

Planning, RLD selection, Prescription Analysis, Comparison of Dissolution Profiles, Comparison of Impurity Profiles, Stability Study, Documentation

In vitro Quality Consistency Evaluation

BE bridge experiments, Clinical Center Selection, Pre-BE and BE Experiments, TE, Bioanalysis, Data Administration, Statistical Analysis and Documentation


 

IV. Food safety and environment monitoring

● Food testing

Contaminants

Pesticide residues, Veterinary Drug Residues, Heavy Metals and Plasticizers;

Illegal additives

Preservatives, Pigments, Melamine;

Nutrients

Vitamins

● Environment

Water, Soil, Air, Sediment, Solid Waste;

DBPs, Ions in Water, P and S in Soil and Sediment