
生物分析(生命科学)
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.

Nearly 1000 bioanalytical methods for
chemical drugs, including more than
330 chemical drug methods with proprietary intellectual property rights

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

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

PK & BE statistics analysis
Statistical analysis of innovative drug safety and efficacy

Clinical sample analysis:
1000/week/project/instrument
Dose escalation of innovative drug:
48 working hours to deliver results

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
03
PK statistical analysis
Statistical analysis of efficacy and safety
04
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









Experimental Instruments
Small Molecule Bioanalysis




-
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



- 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

全内资
无需通过遗传办

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

与NMPA合作
持续开展生物分析行业培训提供咨询服务

质量至上
超过110次中美核查

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

Domestic-Funded Enterprise
No need to go through the Human Genetics Resources Administration of China (HGRAC)

Solid Team Experience and skills
Project leaders have many years of industry experience

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

Quality
As of 2022.06.30
More than 110 inspections by NMPA and FDA

Punctuality
Dose escalation of innovative drug
Small molecule: 48 working hours to deliver results
Large molecule: 72 working hours to deliver results

Xihua Headquarters
Address:Building 5, 6 and 7, Lane 118, Furonghua Road, Pudong New Area, Shanghai
Learn more>Business Consulting
Overseas
Tel:+01-609-921-7115 (US)
Fax: +01-609-921-7116 (US)
Other Consultations
China
Email:IR@xihuasci.com