Service Introduction

InnoStar‘s' Microbiology team specializes in large molecule drug analysis services. The laboratory is equipped with advanced instruments and equipment, and carries out informatization management in compliance with international GLP & GCP quality management standards; we can provide one-stop solutions that meet the requirements of global regulations such as NMPA, FDA, EMA, ICH, etc., including the development and validation of analytical methodologies, preparation of clinical sample collection kits, and lab We can provide one-stop solutions that meet the requirements of NMPA, FDA, EMA, ICH and other global regulations, including analytical methodology development and validation, clinical sample collection kit preparation, and laboratory services such as manual writing and biosample analysis.

The laboratory complies with international GLP & GCP quality management standards, and can provide one-stop macro-molecule bioanalytical services for clinical and preclinical research, including analytical methodology development and validation, clinical sample collection kit preparation, laboratory manual writing and biological sample analysis.
 

Services
-PK analysis
-Protein and cytokine analysis
-Biomarker analysis
Anti-drug antibody analysis
-Neutralizing antibody analysis
-Pharmacodynamic studies (immunophenotyping, receptor occupancy, cell proliferation, intracellular cytokines, etc.)
 

Types of Drugs
-Monoclonal antibodies
-Bispecific/multispecific antibodies
-Recombinant/fusion proteins
-Biosimilars
-ADC class
 

Detectable Substrates
-Plasma
-Serum
-Whole blood
-Bone marrow
-Cerebrospinal fluid
-Urine
-Tissue