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Bioanalysis

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 580 analytical methods have been established, including more than 330 chemical drug methods owned by the company. A total of nearly 800 consistency evaluations and nearly 150 clinical sample analyses of small molecule chemical innovative drugs have been completed.(Data up to 2022.06.30)

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.

服务特色

Nearly 580 bioanalytical methods for
chemical drugs, including more than
330 chemical drug methods with proprietary intellectual property rights 

服务特色

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

服务特色

Roughly 600 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

服务特色

PK & BE statistics analysis

Statistical analysis of safety and efficacy for innovative drug

 

服务特色

Clinical sample analysis:

1000/week/project/instrument

服务特色

10家战略合作临床CRO
国内20多家战略合作临床基地

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 about 370 analysis methods, including more than 40 biological drug analysis methods with proprietary intellectual property rights, completed nearly 100 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 2022.06.30)
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

02

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

 

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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 Expexiences 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:Triple Quad 7500, API 6500plus,
    API 6500,API 5000,API 4000

  • Agilent ICP-MS

  • Agilent GC-MS

  • Agilent FTIR 

  • UPLC: Shimadzu/Waters

  • Automation: Cybio liquid workstations

  • LIMS: Watson LIMS

  • LC-HRMS-UV  

Large Molecule Bioanalysis

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  • Electrochemical luminescence: MSD
  • ELISA: MD Microplate Peader
  • Flow cytometry: BD Fortessa X-20R
  • q-PCR: AB QuantStudio 6/12k Flex System
  • dd-PCR: Bio—Rad QC200 
  • Ultra-sensitive automatic microfluidic immunologicaldetection platform:
    ProteinSimple Ella Simple Elisa
  • Single molecule immunodetector: SET SMCxPRO™, SIMOA
  • Bio-plex 200 suspension chip system: unit
  • CTL ELISA spot analyzer: unit
  • Hba1c analyzer : Tosch G8
  • Coagulometer system:Sysmex CS-2400+CA-620
  • Automation: Tomtec/Hamilton/Tecan liquid handlers
  • Plate washer: Bio-Tek
  • Watson LIMS (including Immune model)

Quality system

Service advantages

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全内资

无需通过遗传办

 

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稳固的团队经验与技术

项目负责人经验

本科至少8年

硕士至少5年

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与NMPA合作

持续开展生物分析行业培训提供咨询服务

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质量至上

超过110次中美核查

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严守时限

创新药爬坡

小分子:48小时提供结果

大分子:72小时提供结果

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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 2022.06.30

More than 110 inspections by NMPA  and FDA

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Punctuality

Dose escalation of

innovative drug

1

Xihua Headquarters

Address:Building 5, 6 and 7, Lane 118, Furonghua Road, Pudong New Area, Shanghai

Learn more>

Business Consulting

China

Tel:+86-21-5808 6608

Email:BD@xihuasci.com

Overseas

Tel:+01-609-921-7115 (US)

Fax:   +01-609-921-7116 (US)

Other Consultations

China

Email:IR@xihuasci.com

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