Technological Platforms_Technological Platforms_Shandong International Biotechnology Park

Analysis and Testing Center

Analysis and Testing Center was built according to CNAS standard (China National Accreditation Service) strictly. The center includes some bio-pharma analysis and testing laboratories according with national standard, such as chromatogram lab, Spectrographic lab, electronic microscope lab, Molecular Biology Laboratory, etc.. The laboratories had more than 30 advanced equipment such as Agilent 1260 Liquid Chromatography, agilent 7890A Gas Chromatograph, PE Frontier Infrared Spectrometer, B7500FAST Real Time Quantitative PCR, NIKON Inverted Fluorescence Microscope, etc. and more than ten professional testing personnel with bachelor degree or above. Furthermore, the Park had cooperated with local scientific academies and institutes such as Yantai Institute of Coastal Zone Research Chinese Academy of Science, Yantai University, Ludong University, Binzhou Medical University, which made the maximize use of local bio-pharma resources.
The center provides different kinds of basic technology services such as certain equipment, information, technology, talent, etc. for the settled-in research enterprises of the Park with preferential price.
At present, the service pattern of the center includes testing application, rent of equipment/facilities, inquiry of professional technology, etc..

Biotechnology Center

The Biotechnology Center is an international technology platform built by Shandong International Biotechnology Park in cooperation with Singapore A-Bio Pharma Pte. Ltd. The center includes more than 40 advanced equipment worth over 1500000 yuan, such as micro-operating system, Quantitative PCR, Flow Cytometry, etc., and master some core technologies such as international leading transgenic animal preparation, CHO cell high-level expression humanized monoclonal antibody, which would do research in transgenic animal, built of animal disease model, antibody drug screening, high-level expression mammalian cell line, prokaryotic cell, yeast expression. At the same time, the center would provide series of technical services such as gene cloning, protein expression and protein purification, antibody expression and purification services for universities, institutes and large-scale pharmaceutical enterprises both at home and abroad.

Long-Acting and Targeting Drug Delivery Technology Center (State Key Laboratory)

Long-Acting and Targeting Drug Delivery Technology Center is built by Shandong Luye Pharmaceutical Co., Ltd. which was ratified by the Ministry of Science and Technology of PRC on January, 2010 and has been the only State Key Laboratory in Yantai since then. The main research direction of the lab is long-acting and targeting drug delivery system including microsphere, liposome, microsphere new preparation and release technology. At the same time, the lab is doing research on long-acting and targeting preparation advanced carrier materials. There are 10 professors, 25 doctors, and academician Jian Ding is the director of the committee. At present, Long-Acting Sustained-Release Microsphere Platform was finished, which has 8 studying project with independent intellectual property rights, 3 of which are in the clinical research phase. Rotigotine Microspheres for injection curing Parkinson's disease had entered American clinical phase which is the first innovative preparation in China did clinical research in developed country and also the first new long-acting sustained-release preparation curing Parkinson's disease entered in clinical phase in the world. In aspect of Liposome research, the lab is the earliest unit doing Liposome research and realized industrialization of Liposome successfully. liposome product of paclitaxel (Lipusu®）, the core product, is the first liposome medicine approved by SFDA with the largest sales revenue in China. The sales revenue in 2011 will be 700,000,000 yuan. At present, there are 5 in-process liposome projects, 1 of which had been in clinical second period. The lab had applied 64 patents, and issued more than 20 academic dissertations. The lab implemented 3 national specific projects.

Drug Screening and Evaluation Technology Center

The center includes various professional equipment, such as molecular biology lab, immunobiology lab, cell biology lab, Pharmacology lab, and animal breeding room, CO2 incubator, PCR, ELIASA,Pulsed-field gel electrophoresis system, inverted fluorescence microscope, laser scanning confocal microscopy, high speed refrigerated centrifuge, DNA sequencer, Flow Cytometry, protein stability analysis system, etc.. The center could do pre-clinical screening and evaluation for new drugs from molecular, cell, isolated specimens and the whole animal.
At present, the center would provide the following services: molecular biology research of effect and effect mechanism of new drug , preparation of transgenic cell line and transgenic animal to do target point practical research, in Vitro Pharmacodynamical research on cell system model and isolated organs, in vivo activity research on diverse animal models.

Drug Safety Evaluation Center (State GLP Laboratory)

Drug Safety Evaluation Laboratory of Shandong International Biotechnology Park was approved by State Food and Drug Administration. The functional labs of the center include: animal breeding room, center lab, Toxicokinetics lab, molecular biology lab, cell lab, genotoxicity lab, Pathology Laboratory, test article storeroom, test article appointment lab, archives, etc.. The center also includes SPF lab, huge animal lab and normal lab which could do research on different species of animal such as monkey, dog, rabbit, guinea pig, rat, and mice. At present, the center provides GLP services: acute toxicity test, long-term toxicity test, local skin irritation, immunotoxicity and toxicokinetics experiment. At the same time, the center is carrying forward the approvement of normal Pharmacology, genotoxicity, procreation and Carcinogenicity test. The technology group of the center has rich experience, which had finished GLP test application of diverse new drugs, and passed. At present, the center cooperated with several research institutes and academy both at home and abroad and planned to build a GLP center with international standard and will put into use within two years.

PK/PD Technology Center

PK/PD Technology Center is the key links in the research proceed of drug. The research field of the PK/PD technology center of the park includes: pre-clinical PK/PD, toxic kinetics, Bioavailability of preparation and bioequivalence, etc.. The main equipment of the center include: HPLC, QC, LC/MS/MS, QC/MS, QPCR, etc., and instrument room, Cell Culture Room, animal laboratory, biology sample treatment room. At present, the services of the center include: Caco-2 cell model test, Drug-plasma Protein Binding rate test, hepatic microsomal enzyme inhibition and induction, drug absorption test, pharmacokinetics test, tissue distribution test, toxicokinetics test, Bioavailability test, drug excretion, metabolites isolation and identification, etc.

Marine Biotechnology Research Center

Marine Biotechnology Research Center was built by Shandong International Biotechnology Park cooperated with Yantai Institute of Coastal Zone Research Chinese Academy of Science and Shanghai Institute of Materia Medica Chinese Academy of Sciences. The center developed high value-added products such as low-cost marine bioactive substance, technology breakthrough of scaled biotechnology and marine drugs through depth research of marine animals, plant and animalcule resources.
The center has more than 15 research personnel with master degree or above and allocates with professional equipment such as Lending freeze centrifuge, spray dryer and biologic duoflow. The center provides technology services such as screening of marine bioactive substance, extraction separation and purification and product development to promote transformation of scientific and technological achievement and technical radiation.
At present, the center had gained project establishment support of several state technology development plan and provincial and municipal development plan.

Pilot Plant

Pilot plant is the key links for industrialization of scientific and technological achievement. At present, the Park built professional biotechnology drug pilot plant, chemical synthesis drug pilot plant and traditional Chinese medicine and natural drug pilot plant to help enterprises to industrialize achievement.