Technical services

BSL-3 Lab

WIBP’s BSL-3 lab is the first enterprise-operated P3 laboratory in China in the field of human infectious diseases, in which we can carry out experiments on highly pathogenic microorganisms at cell level, rodent level and non-human primate level, and which can meet the needs of preclinical development of vaccines against emerging infectious diseases. It has become an important experimental platform for the research of emerging infectious diseases in the vaccine field. The experimental area consists of four units, including 2 BSL-3 microbiology laboratories, 1 ABSL-3 small animal laboratory, and 1 ABSL-3 medium-sized animal laboratory.

[Experimental activities carried out]

1.Handling of virus at cellular level: detection of COVID-19 neutralizing antibody, effectiveness evaluation of anti-SARS-CoV-2 drugs and antibodies, evaluation of antigen detection kit and effectiveness evaluation of disinfectant.

2.Infectious test of rodents (mice and golden hamsters): evaluation of preventive or therapeutic effects of vaccines, drugs and antibodies against SARS-CoV-2.

3.Infectious test of non-human primates (monkeys): evaluation of preventive or therapeutic effects of vaccines, drugs and antibodies against SARS-CoV-2.

[Contact Us]

Contact person: Ms. Lu

Tel: 027-86634151

E-mail: johnsonchau@163.com


Service for pilot test and achievement transformation of vaccines and therapeutic drugs

WIBP has more than 200 sets of instruments and equipment for pilot tests and 53 sets of large-scale instruments and equipment. In 2023, it was filed on the pilot platform for transformation of scientific and technological achievements in Wuhan, and won the honor of Wuhan Achievement Transformation Center. It has a sound technical system for front-end development of vaccines and therapeutic drugs and pilot scale-up, giving full play to the supporting role of the pilot platform in the transformation of scientific and technological achievements, and playing an active role in the development of drugs and vaccines in Hubei Province.

[Scope of Pilot Service]

Laboratory development of vaccines and therapeutic drugs for infectious diseases, process development of pharmaceutical products, methodology establishment, pharmacodynamic evaluation and qualification of quality documents; technical service of conceptual validation, laboratory test, pilot test and sample preparation of viral vaccines, bacterial vaccines and therapeutic drugs; highly pathogenic pathogen detection, cell and animal model establishment and evaluation services.

[Contact Us]

Contact person: Ms. Nian

Tel: 027-88843621

E-mail:nianxuanxuan@126.com


Testing

The Quality Control Department of WIBP adheres to the working principle of "objectivity, fairness, science and accuracy", strictly follows ISOIEC17025, and establishes quality management documents, quality control system, laboratory internal audit and management evaluation system in line with international standards from six aspects: people, machines, materials, methods, environment and measurement. In June 2017, it obtained the laboratory accreditation certificate issued by the China National Accreditation Service for Conformity Assessment (CNAS). The team works in the laboratory is professional, with reasonable structure, rich experience and first-class quality. The laboratory conforms to GMP requirements and CNAS concepts, and it has more than 400 advanced testing instruments and equipment. It’s engaged in bacteria and virus cell bank, pharmaceutical water, raw and auxiliary materials and packaging materials, intermediate products, finished products, clean room environment validation and monitoring, etc., ensuring that the quality and standards of the testing are in stringent accordance with Chinese Pharmacopoeia and relevant laws and regulations.

[CNAS Accredited Testing Items]

1.Biological products: RFFIT, toxicity reversion, specific toxicity, toxoid floccule unit, bacterial endotoxin, abnormal toxicity, identification of virus seeds, antibiotic residue, intracerebral pathogenicity, reverse mutation test in suckling mice, reverse transcriptase assay, etc.

2.Packaging materials for pharmaceutical products: acute systemic toxicity test, determination and classification of hydrolytic resistance of inner surface at 121 ℃, determination and classification of hydrolytic resistance of glass grains at 121 ℃, pyrogen test, etc.

3.Drugs: light transmittance, absorbance, relative density, melting point, optical rotation, pH value, protein content, chloride, sulfate, iron salt, heavy metal, arsenic salt, ammonium salt, weight loss on drying, ignition residue, easy carbonization, total organic carbon, conductivity (pharmaceutical water), solution color, etc.

[Contact Us]

Contact person: Ms. Shi

Tel:027-86634028

E-mail:shiyanhong1@sinopharm.com


Rabies related tests

The Rabies Testing Center of WIBP is the first professional rabies testing center in China, which mainly provides services such as anti-rabies virus neutralizing antibody test, rabies virus isolation, laboratory diagnosis of rabies patients and rabies virus antigen test. The center is composed of top scientists, including one member of WHO Rabies Expert Committee, one member of National Pharmacopoeia Committee, one member of Rabies Prevention and Control Working Committee of Chinese Preventive Medicine Association and one expert of Rabies Vaccine Working Group of Chinese Center for Disease Control and Prevention.

[Research Achievements]

Our Rabies Testing Center is the first in China to establish Rapid Fluorescence Focus Inhibition Test (RFFIT) to detect neutralizing antibodies against rabies virus. The method has been included in the Chinese Pharmacopoeia since 2010, and can be used to determine the titer of rabies immunoglobulin and evaluate the immunogenicity of rabies vaccine. In 2018, the Rapid Fluorescence Focal Inhibition Test (RFFIT) conducted by the Rabies Testing Center was accredited by CNAS.

[Technical Services]

1.RFFIT detection of rabies virus antibody in blood samples from all over the country (including rabies hysteria patients);

2.RFFIT detection of rabies virus antibody in blood samples for scientific research or product development;

3.RFFIT detection of rabies virus antibody in antigen samples provided by CDC and judicial doctors;

4.Provide training for rabies detection technicians from National Medical Products Administration, National CDC and rabies-related product manufacturers, and also provide dedicated training on RFFIT technology.

[Contact Us]

Contact person: Mr. Zhao

Tel:027-88913353

E-mail:103609879@qq.com


Laboratory animal

The Laboratory Animal Center of WIBP is engaged in laboratory animal production and test, and it is one of the most important laboratory animal production and use units in Hubei Province. Its hardware facilities are at the first-class level in Hubei Province and even the central region of China. As the largest laboratory animal production base in Hubei Province, it has established a complete production, breeding, supply, quality control system and a sound laboratory animal transportation management system. The quality of laboratory animals is stable and reliable. It is an important public service platform for biopharmaceutical production, testing, new product development and teaching in Hubei Province, and has played an active role in promoting the development of related biomedical industries such as drug and vaccine development in Hubei Province.

[Scope of Animal Services]

1.The main species produced are: SPF hamster, SPF mouse (KM mouse, NIH mouse and BALB/c mouse), SPF guinea pig and common Japanese white rabbit. The production scale meets the needs of laboratory animals for biomedical production, testing, R&D animal test and teaching.

2.There are ABSL-1, ABSL-2 and ABSL-3 laboratories with ordinary environment, barrier environment or barrier environment+IVC system. They are mainly used for animal testing on biomedical products and R&D animal tests, and can provide animal test platform services for SPF animals (mice, rats, hamsters and guinea pigs) and ordinary laboratory rabbits, including laboratory development of vaccines against infectious disease and therapeutic drugs, process development of pharmaceutical preparations, methodology establishment, pharmacodynamic evaluation and quality document confirmation, conceptual validation, laboratory test and pilot test technical services and sample preparation of viral vaccines, bacterial vaccines and therapeutic drugs, highly pathogenic pathogen detection, cell and animal model establishment and evaluation services.

[Contact Us]

Contact person: Mr. Zhang

Tel:13886079878

E-mail:258277291@qq.com