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Bioanalysis

BIOANALYSIS

Service introduction

Small Molecule Bioanalysis

The business of chemical bioanalysis was officially launched in 2015, and the company has more than 50 chemical bioanalysis experts, among which more than 40% of the employees have more than 5 years of experience in GLP chemical bioanalysis. The company has established good cooperative relations with more than 300 enterprises at home and abroad, and carries out business in many countries around the world. 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. As of June 30, 2022, Xihua has more than 330 chemical biological analysis methods with independent intellectual property rights.
The department of chemical and pharmaceutical Bioanalysis has 5 staff with more than 10 years of experience in small molecule bioanalysis, all from well-known domestic and international CRO or pharmaceutical companies. 8 project leaders with more than 5 years of work experience. In addition, according to the ratio of support personnel: laboratory personnel = 1:10, Xihua has additional personnel dedicated to chemical QC, QA, sample management and equipment management, to support the efficient operation of chemical biological analysis.

服务特色

Nearly 1000 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

Totally serving nearly 600 domestic and foreign customers
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 innovative drug safety and efficacy

服务特色

Clinical sample analysis:

1000/week/project/instrument

Dose escalation of innovative drug:

48 working hours to deliver results

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

The bioanalysis business of biological drugs, established in 2015, has a complete quality system, systematically verified instruments and electronic systems, and can provide bioanalysis services of clinical samples that meet the requirements of Chinese and Western drug application. Data as of 2022.06.30, there are more than 30 biological drug bioanalysis experts. There are 4 personnel with more than 10 years of macromolecular bioanalysis experience, all from domestic/international well-known CRO or pharmaceutical companies; 9 employees with 5 years of master's/doctor's experience and more than 8 years of undergraduate work experience; There are altogether 8 project leaders. In addition, according to the proportion of 10%, Xihua detection also equipped with special macromolecular QC, QA, sample management personnel and equipment management personnel, to support macromolecular biological analysis.
Xihua Macromolecular Bioanalysis group is mainly engaged in the biological analysis of clinical samples of mab, polyclonal antibody, ADC, fusion protein, polypeptide, gene therapy, vaccine, CAR-T, heparin, coagulation factor and other types of drugs. It can support the detection of PK, ADA, Nab (binding assay and cell assay), biomarkers, in vivo efficacy, flow cytometry, ELISPOT and other aspects of the drug. As of June 30, 2022, the company has accumulated about 370 analytical methods, including more than 40 self owned intellectual property biological drug analytical methods, completed nearly 100 clinical trial sample analysis of biological innovative drugs and biological analogues, and completed more than 70 drugs approved for listing in biological analysis projects.
With entity operations in both China and the United States, Xihua Macromolecular Bioanalysis can support both domestic and foreign bioanalysis businesses 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

Dose escalation of innovative drug:72 working hours to deliver results

05

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

Macromolecular Biological 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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Domestic-Funded Enterprise

No need to go through the Human Genetics Resources Administration of China (HGRAC)

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Solid Team Experience and skills

Project leaders have many years of industry experience

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Cooperation With NMPA

Conduct training in the clinical sample analysis continuously;
Offer consultation services

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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

Small molecule: 48 working hours to deliver results

Large molecule: 72 working hours to deliver results

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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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