BIOANALYSIS



Service Introduction

Small Molecule Bioanalysis

The business of chemical bioanalysis was officially launched in 2015. With the entity operation in China and the United States, the company can support the bioanalysis business in China and abroad with high efficiency and quality. The company's small molecule bioanalysis business has rich experience in areas of high technical difficulty, such as inhalants, liposomes, high sensitivity, instability, endogenous drugs, peptide drugs, etc. At present, more than 1000 analytical methods have been established, including more than 380 chemical drug methods owned by the company. A total of more than 800 consistency evaluations and over 300 clinical sample analyses of small molecule chemical innovative drugs have been completed.(Data up to 2024.03.30)

Xihua is also equipped with special QC, QA, sample management and equipment management personnel in accordance with a certain proportion to support the efficient operation of biological analysis of chemical drugs.

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Nearly 1,000 bioanalytical methods for
chemical drugs, including more than
380 chemical drug methods with proprietary intellectual property rights 

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Experienced with difficult methods such as inhalers, liposomes, high sensitivity, instability, endogenous drugs, insulin, etc.

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More than 300 domestic and international clients
Most of the top 50 domestic and the top 10 global pharmaceutical enterprises
also covers small and medium-sized Biotech enterprises

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PK & BE statistics analysis

Statistical analysis of safety and efficacy for innovative drug

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Clinical sample analysis:

1000/week/project/instrument

Large Molecule Bioanalysis

Large molecule bioanalysis business, established in 2015, has a complete quality system, systemically verified instruments and electronic systems, and can provide clinical sample bioanalysis services that meet the requirements of Chinese and Western drug application. Xihua large molecule bioanalysis Group is mainly engaged in the biological analysis of clinical samples of monoclonal antibody, polyclonal antibody, ADC, fusion protein, peptide, gene therapy, vaccine, CAR T, heparin, coagulation factor and other types of drugs. It can support the detection of PK, ADA, Nab (combination assay and cell assay), biomarkers, in vivo efficacy, flow cytometry, ELISPOT, etc. In addition, in accordance with a certain proportion, Xihua is also equipped with additional personnel dedicated to chemical QC, QA, sample management and equipment management, to support the efficient operation of macromolecular biological analysis.

The company has accumulated more than 600 analysis methods, including more than 40 biological drug analysis methods with proprietary intellectual property rights, completed over 200 biological innovative drugs and biosimilar drug clinical trial sample analysis, completed biological analysis projects have more than 70 drugs approved for market.(Data up to 2024.03.30)
Xihua large molecule bioanalysis operates in both China and the United States, and can support the business in China and abroad with high efficiency and quality. 

01

Development and validation of the analytical methods of PK, ADA, Nab and biomarker of macromolecules

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Analytical methods developed for 40+ biosimilar drugs and 100+ innovative drugs

03

PK statistical analysis

Statistical analysis of efficacy and safety

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Clinical sample analysis:

500 samples / week / project

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Reagent development and labeling

Project Experience

Small Molecule Project Experience

Regular chemical drugs Peptide
ADC drugs
(toxin and linker)
Oligonucleotide
(AS0, siRNA)
PROTAC molecule Biomarkers
including endogenous compound)
Metallic drug Inhalant
Liposome Metabolite identification
of innovative drug

Project Experiences On Large Molecule Bioanalysis(Partial)

BIOSIMILARS OTHER INNOVATIVE
Adalimumab PEG - GCSF Monoclonal Antibodies
Bevacizumab FSH ADC
Denosumab Etanercept Peptides
Ramucirumab Insulin Degludec PEGylated Drugs
Rituximab Exenatide Fusion Protein
( Fc , CTP )
Panitumumab liraglutide Coagulation Factors
Pertuzumab Semaglutide Enzymes
Trastuzumab Enoxaparin Sodium Blood Products
Cetuximab Nadroparin Calcium Nucleic Acid Drug

Large Molecule Platform

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Experimental Instruments

Small Molecule Bioanalysis

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  • LC/MS:
  • AB Sciex API 7500
  • API 6500plus
  • API 6500
  • API 5000
  • API 4000
  • HRMS: Thermo QE (LC-QE-UV)
  • ICP-MS: Agilent 7800
  • UPLC: Shimadzu/Waters
  • IR: Agilent FTIR
  • Automation: Cybio Liquid Workstation
  • LIMS: Watson LIMS

Large Molecule Bioanalysis

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  • Electrochemical luminescence: MSD
  • ELISA: MD Microplate Peader
  • Ultra-sensitive automatic microfluidic immunologicaldetection platform:
    ProteinSimple Ella Simple Elisa; SIMOA; HD-X/SMCxPRO

  • Workstation:Gyrolab xP
  • Luminex
  • ELISpot:CTL
  • Flow cytometry: BD Fortessa X-20R
  • dd-PCR: Bio—Rad QC200 
  • q-PCR: AB QuantStudio 6/12k Flex System
  • Others: Tosch G8; Sysmex CS-2400+CA-620
  • Automation: Tomtec/Hamilton/Tecan liquid handlers
  • Watson LIMS (including Immune model)

Quality System

NMPA
FDA
MHRA
EMA
WHO
ICH
OECD

Service advantages

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First-mover advantage

Deeply engaged in bioanalysis and

rich experience in the field of bioanalysis

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Solid Team Experience and skills

Project leaders have many years of industry experience

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International Service

Able to meet customers' needs for China-US dual declaration and global multi-center clinical declaration

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Quality

As of 2023.06.30

More than 110 inspections by NMPA  and FDA

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Punctuality

Dose escalation of

innovative drug