Clinical Trials and
Laboratory Services

TriApex, with regulatory-compliant bioanalyis labs, can provide integrated bioanalysis services for preclinical and clinical studies to provide scientific, rigorous and efficient support for the sponsors' drug R&D.

Service Advantages

1. Experience in method development and validation (1000+)

Bioanalysis methods for hot target drugs (15+)

Bioanalysis methods for peptides

Bioanalysis methods for non-viral delivery vectors

Bioanalysis methods for viral delivery vectors

Bioanalysis methods for New Chemical Entity

Bioanalysis methods for oligonucleotides

Bioanalysis methods for PROTAC

Bioanalysis methods for endogenous substances

2. Risk-based integral assessment of immunogenicity

Assessment of immunogenicity risk level

Comprehensive services including screening assay, confirmation assay, characterization assays and neutralizing assay

Experience in ADA positive antibodies’ preparation (50+)

Commonly used virus delivery vector immunogenicity and neutralizing antibody detection methods

Multi-type proteins and antibodies labeling techniques

ELISpot analytical methods

Analytical methods for humoral immunity and cellular immunity of vaccines

3. Adequate biological resource pool

Serum, plasma, whole blood, blood cells, cerebrospinal fluid, tears, tissues (common tissues and eye tissues, nervous system tissues), etc

Service Capacities

Integrated Bioanalysis from Preclinical to Clinical

Pharmacokinetics/ Toxicokinetics

ADME study

Bioanalysis of clinical trials at different stages

Bioanalysis analysis of BA/BE/Comparability study

Risk-based immunogenicity and immunotoxicity analysis

Anti-drug antibody analysis (screening, confirmation, titer)

Neutralizing antibody analysis (Cell based/non-cell based assay)

ADA characterization analysis

Cellular immunoassay (ELISpot, intracellular cytokine staining)

Cytokine release

Immune cell phenotyping

T-cell dependent Antibody Response (TDAR)

Circulating immune complex

Drug class


Therapeutic Antibodies

Conjugate drug (ADC/PDC)

Cell therapies

Gene therapies (viral vector/non-viral vector)

New Chemical Entity (NCE)



Vaccines (recombinant protein /mRNA)

Project Experience

Drug Type

Typical Drug



Liraglutide/Dulaglutide/Multifunctional domain fusion protein


Therapeutic Antibodies

Monoclonal Antibody, Bispecific Antibody, Trispecific Antibody

Targets:OX40、OX40L、BCMA,CD3、CD20、CD25、CD47、CEA、LY6G6D、CD30、CD32a、PD-1、PD-L1、Claudin18.2、FLT3、TSLP、CCR8、Siglec 15、CTLA4、NKG2A、CDx、MASP-2、SIRPα、TIGIT、VEGF、IL-33R、Her2、cMET、EGFR、NKG2A、singlec 15、TGF   β、4-1BB、GITR、LGA-3、TIM-3。

Conjugate drugs


Targets:Her2 、Trop2 、Claudin-18.2、CD30、CD70、DLL3。


Cell Therapies

Car-T, Stem Cell Therapy

CD19 target, modular Car-T, In vitro induced stem cells

Gene Therapies

Viral vector, non-viral vector

AAV vector, adenovirus type 5 and other viral vector products; In vivo gene editing products.



Anti-cancer, anti-infection, antiviral, anti-allergy drugs, antipyretic analgesic, drugs with indications such as hypertension, cardiovascular disease, central nervous.





Recombinant protein, mRNA

COVID-19 vaccine, preventive tumor vaccine, etc.


NMPA, 2020, Chinese Pharmacopoeia 9012  Guidelines for Bioanalytical Method Validation for Quantitating Study Samples

ICH M10: Bioanalytical method validation and study sample analysis

US FDA GLP FDA:Bioanalytical Method Validation Guidance for Industry

EMA: Guideline on bioanalytical method validation