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Address : 1262 West Yanan Road ,Shanghai
Tel : 62803189
Zip : 200052
Fax : 62801807
Email: sibp@siobp.com
 
 
Scientific Research and Development
 
R&D Institutes
 

1. Department Introduction
The R&D Department is one of the functional departments. It is mainly responsible for the management of the scientific research topics in the whole institute, registration and declaration of the medicines, application for funds and patent, declaration of commercialization of research achievements, academic exchange and management of different kinds of academies and associations.

In 2006-2007, the enterprise invested 50 million yuan independently in the new R&D building. The new R&D building was built in accordance with GLP, and an experiment center was designed and built, which can be applied to different kinds of vaccines and the research and development of the products; the special middle trail workshop was designed and built in accordance with GMP. The building was completed in the end of 2007, and was put into use. It covers an area of more than 4000㎡ with one floor under the ground and 4 floors on the ground. After the rebuilding, it has been an R&D building with first-rate facilities and complete functions, which engages in the basic researches in the field of biotech including the researches of molecular biology, platform for humanized monoclonal antibody technology, genetic engineering, proteomics, virus vector-mediated prophylactics, bacterial polysaccharide vaccines, viral vaccines, plasma protein products, biotech informatics and epidemiology, diagnostic reagents and microecology, comprehensive biotech, and laboratory animal and application and development of the scientific achievements.

In 2007, SIBP was evaluated as Changning District Enterprise Technology Center; in 2008, it was evaluated as Shanghai Enterprise Technology Center. All these indicate that our comprehensive abilities such as R&D capability, technique level, and the continuing invest in R&D are at a new level, and also raise new requirements and standards to our ability of organization and management of research projects.

2. R&D Institutes (brief introduction of the research offices)

There are 9 research offices and a laboratory management center. Their functions are as follow:
First Research Office: research areas: molecular biology, monoclonal antibody technology
Second Research Office: research area: genetic engineering, proteomics
Third Research Office: research area: bacterial polysaccharide
Fourth Research Office: research area: molecular virology
Fifth Research Office: research area: plasma protein products
Sixth Research Office: research area: biotech informatics, epidemiology
Seventh Research Office: research area: diagnostic reagents, microecology
Eighth Research Office: research area: comprehensive biotech research
Ninth Research Office: research area: laboratory animal
Laboratory Management Center: research area: offering service assurance to R&D, coordinating work

As of the end of 2009:
Among a total 153 science and technology activity staff, 10 are scientific management staff, 12 are scientific service staff, and 131 R&D professionals directly engage in the Research projects. 8 of all the professionals are doctors, 27 are postgraduates, 49 are university graduates, 31 are junior collage graduates, and 35 are under postgraduates. 20 of the staff are with senior title and 66 are with middle title.

 
Research Projects
 

Finished key research projects:

Live attenuated measles, mumps and rubella combined vaccine: at the beginning of 1960s, SIBP successfully isolated the first strain of measles virus Hu 191 used in vaccine production. In 1991, SIBP established joint research with Netherlands National Institute for Public Health and Environment (RIVM) by China Vaccine Project, first successfully researched and developed the strain of measles virus Hu 191 without pollution of fowl leukosis virus and with higher safety. At the same time, a three-tier seed bank for purification of virus seed was established, and started the domestic live attenuated measles vaccine production after the validation of National Institute for the Control of Pharmaceutical and Biological Products, further improved the safety and effectivity of the vaccine. Moreover, SIBP first used the purified virus seed of measles virus Hu 191 successfully developed a series of measles vaccines, including measles vaccine, live attenuated measles and mumps combined vaccine, live attenuated measles, mumps and rubella combined vaccine (MMR, which obtained New Drug Certificate and Drug Registration Document in 2008, formally put into mass production, and became the new economic growth point.), and live attenuated measles, mumps, rubella and varicella combined vaccine(MMRV) are being developing.

H1N1 Influenza A Vaccine (Split Virion), Inactivated: In Sep.10th, 2009, in Center for Drug Evaluation, State Food and Drug Administration, inactivated split H1N1 influenza A vaccine developed by SIBP passed the technical appraisal of the specialists, passed the administrative examinations and approval 3 days later, and formally obtained National New Drug Certificate and Pharmaceutical Product License Number. SIBP uses advanced production techniques, and unique splitting methods to stabilize the quality of vaccines, and minimize the content of egg albumin and clinical side effects. The vaccines have achieved the international standard, and effects of immunization have reached over 90%.

The vaccine approved this time is for the vaccination of children above 3 years old and the adults. The specification are 15μg/0.5ml/vial(vial)and 15μg/0.5ml/amp(prefilled syringe). Now it has been put into mass production, and the expected productivity in the end of the year will be 8 million- 10 million doses in order to meet the needs of susceptible people and national reserve. At present, SIBP has received vaccine purchasing and storage orders from Ministry of Industry and Information Technology.

Other developing projects:

The main research direction of SIBP is developing combined vaccines, comprehensive utilization of blood, Hib polysaccharide conjugate vaccine, long-acting interferon, and platform for humanized monoclonal antibody. Furthermore, in view of rapid development of biotech at present, other new vaccine and therapeutic goods are also developed. The institute takes the way of giving priority to innovation, import assists and independent innovation, introduction and assimilation-based innovation and integrated innovation, adheres to the road of sustainable development of technology, in order to make blood products and vaccine biological products to be the pillar of industrialization, and focus on the research and development of therapeutic products.

Now the key projects of research and industrialization are:
Development of human coagulation factor VII
Development of live attenuated Japanese encephalitis vaccine (project of Science and Technology Commission of Shanghai Municipality)
Development of Hib conjugate vaccine (project of Science and Technology Commission of Shanghai Municipality)
Development of long-acting recombinant human interferonα1b for injection (project of the March 1986 Hi-tech Program)
Project of Science and Technology Commission of Shanghai Municipality, owns intellectual property rights for key technology, and authorized patent.
Research and development of pandemic influenza vaccine (project of Science and Technology Commission of Shanghai Municipality)
Research and development of updating of large-scale production technique of varicella vaccine and new lyophilizing vaccine protection agent (project of National Science and Technology Support Program)
Development of new tuberculosis vaccine (Major Project of Ministry of Health in Terms of Major Infectious Diseases)
Development of mass product of live attenuated measles, mumps and rubella combined vaccine (project of National Science and Technology Support Program)
Construction of platform for humanized monoclonal antibody (project of National Science and Technology Support Program)
Development of HPV

In accordance with needs of next economic development, the ongoing projects of high-tech industrialization and large-scale technical transformation are as follow:
GMP rebuilding of Blood Product Production Workshop (development of industrialization of blood products)
Laboratory Animal Room
Workshops of Lyophilized Powder for Injection and Filling III
Plasma Detection Workshop
Fengxian Vaccine Industrial Base

 
International Cooperation
 

International Cooperation Department of Shanghai Institute of Biological Products is mainly responsible for the international academic exchange, technical cooperation, export trade and reception of foreign affairs. In the resent years, with the flourishing development of international exchange, SIBP has established friendly cooperation relationship with experts from the United States, Netherlands, Russia, Britain, France, Australia, Japan, Korea, India, Pakistan and the World Health Organization, which has effectively pushed the enterprise’s economic growth. SIBP has obtained the decision-making power to be engaged in import and export trade authorized by Ministry of Foreign Economic Relations and Trade, and the products including prophylactics, blood products to many countries and areas in the world.

In February of 2009, Vice President Research and Development and Vice President Operations of Belgium GlaxoSmithKline (GSK) Company visited SIBP for communication of cooperation of vaccine development techniques.

In March of 2009, President of Korea Glovax Company visited SIBP for talks on the progress of the Hib vaccine cooperation project.

In September of 2009, Director and his party of Netherlands Vaccine Institute (NVI) visited SIBP.

 
Awards
 

Live attenuated varicella vaccine: SIBP imported the strain of varicella Oka and the production and inspection techniques from Japan BIKEN, and finished the clinical research in November of 2000. In May of 2001, it was issued Workshop Certificate of GMP for Human Drugs and Product License Number authorized by State Food and Drug Administration, and successfully developed the live attenuated varicella vaccine. SIBP is the first enterprise that obtained the Production Approval of live attenuated varicella vaccine, and is the biggest enterprise of live attenuated varicella vaccine production in China at present. The live attenuated varicella vaccine of SIBP has never caused a serious adverse drug reaction, and plays a good role in prevention and control the spread and incidence of varicella.

Split influenza virus vaccine: SIBP first developed Split influenza virus vaccine in 2001, and put it into production in 2002. SIBP is the first and the biggest enterprise of split influenza virus vaccine production. The vaccine is made by using the advanced techniques of BIKEN, and is made by the procedures of virus cultivation, virus concentration, first purification, virus split, and second purification. The effective antigen is reserved, and viral lipid with reactogenicity is removed. The purity of the product is better than the standard of WHO, so the safety of the vaccine is better than whole virion influenza vaccine. Shangsheng split influenza virus vaccine has obtained the qualification of Shanghai Hi-tech Achievement Transformation Program, Certificate of Shanghai Science and Technology Achievement, Certificate of National Key New Product, and the title of Shanghai Famous Quality Product.

Present Awards:
In 2007, SIBP was obtained Certificate of Changning District Enterprise Technology Center authorized by Changning District Economic Commission, Shanghai.
In 2008, SIBP was evaluated as Shanghai Enterprise Technology Center by Shanghai Municipal Economic & Information Technology Commission.
In 2008, construction of reversed genetics technical platform for viral strain used in production of human avian influenza and inactivated seasonal influenza vaccine and development of human coagulation factor VIII preparation were respectively awarded the Second and Third Award of Science and Technology Progress set by China National Biotech Group.
In 2008, International Journal of Biologicals major sponsored by SIBP, was granted Grade III Award of AstraZeneca Excellent Journals of Chinese Medical Association.
In 2009, live attenuated measles, mumps and rubella combined vaccine was awarded A Level Certificate of Shanghai Hi-tech Achievement Transformation Program
In 2009, a preparation method of MMR won the Gold Award of The Twenty-second Shanghai Excellent Invention Tryout and the development of live attenuated varicella vaccine won the Silver Award.
In 2009, research and application of the key technology based on stem cell bone repair obtained the Second Award of Shanghai Science and Technology.

 
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