GMP & GLP Solutions

Isotopic Labeling & Custom Synthesis

Labelling Compounds include

Small molecule compounds, peptides, proteins, macromolecular compounds, nanomaterials, DNA, RNA, antibody/antibody derivatives, cells, etc.

Isotopes include

³H、¹⁴C、¹¹C、¹⁸F、⁶⁸Ga、⁸⁹Zr、^99mTc、¹²⁵I、¹³¹I, etc.

Radioisotope labeled drug ADME studies

Preclinical Studies

Multiple animal models (mice, rats, pigs, dogs, and monkeys) are provided for in vivo ADME experimental studies with isotope (³H, ¹⁴C, ¹²⁵I) - labeled subjects

■ Recovery, excretion and mass balance results of total radioactivity in urine, feces, and bile

■ Distribution and elimination of the total radioactivity in the designated tissues

Radioisotope labeled drug ADME studies

Preclinical Studies

Multiple animal models (mice, rats, pigs, dogs, and monkeys) are provided for in vivo ADME experimental studies with isotope (³H, ¹⁴C, ¹²⁵I) - labeled subjects

■ Tissue distribution of total radioactivity in mice or rats through quantitative whole-body autoradiography

■ Plasma concentration-time profiles for total radioactivity in whole blood 

■ Drug metabolite profiling and identification

Radioisotope labeled drug ADME studies

Clinical Studies

■ Total radioactivity concentration-time profiles in plasma and whole blood；

■ Plasma concentration-time profiles for non-radiolabeled drugs, including the parent drugs and metabolites；

■ Statistics of pharmacokinetic parameters of total radioactivity, parent drug and metabolites in plasma；

■ Excretion rate-time profiles of radioactivity in urine, feces, and total excretion； 

■ Quantification of radioactivity associated with parent drug and identified metabolite in each collection matrix (such as plasma, urine, feces, etc)；

■ Biotransformation pathways of metabolite structures or analysis of metabolites

Drug discovery and development

Drug discovery and development

Development and pharmaceutical research for new diagnostic (PET/ SPECT) and therapeutic radiopharmaceuticals

Research Field

Neurological diseases, neoplasms, cardio cerebrovascular diseases, metabolic diseases, etc.

In vivo animal imaging pharmacokinetic and pharmacodynamic studies

Drug categories

■ Bio-macromolecules labeled with ¹²⁵I, ^99mTc, ⁶⁸Ga, and ⁸⁹Zr

■ ⁶⁸Ga-labeled small molecule compounds

■ ¹⁸F-labeled fluoride compounds

■ ¹²⁵I and ⁸⁹Zr labeled cells or antibody based drugs

Multiple animal models

Mice, rats, pigs, dogs, and monkeys