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 Advantages1. 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 CapacitiesIntegrated 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 classHormones/Peptides/Proteins
Therapeutic Antibodies
Conjugate drug (ADC/PDC)
Cell therapies
Gene therapies (viral vector/non-viral vector)
New Chemical Entity (NCE)
Oligonucleotides
PROTAC
Vaccines (recombinant protein /mRNA)
Project ExperienceDrug Type | Typical Drug | Examples |
Hormones/peptides/proteins | Liraglutide/Dulaglutide/Multifunctional domain fusion protein | GLP-1，FC GLP-1，rhVEGF-FC，PEG-rhG-CSF，rhTPO，GLP1R，NGF, etc. |
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 | ADC，PDC | Targets：Her2 、Trop2 、Claudin-18.2、CD30、CD70、DLL3。 Payload：DXd、MMAE，SN-38。 |
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. |
NCE | NA | Anti-cancer, anti-infection, antiviral, anti-allergy drugs, antipyretic analgesic, drugs with indications such as hypertension, cardiovascular disease, central nervous. |
Oligonucleotides | siRNA， ASO | Gal-NAC-siRNA、ASO |
Vaccines | Recombinant protein, mRNA | COVID-19 vaccine, preventive tumor vaccine, etc. |
GuidelinesNMPA, 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
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