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HOME | Business Introduction | CMO |
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Our company has passed the Korea Food & Drug Administration's standard for manufactory facility standards and have been supplying cells for emergency clinical trials and investigator's trials using marrow stromal stem cell and hematopoeitic stem cell. We are currently in the process of two clinical trials for commercialization, possessing the finest research capability. With this as basis, we also carry out proxy services for researchers who are interested in stem cell research but face difficulty due to lack of experience or proper facilities. |
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¢Á Verification of characteristics and storage of adult stem cells
¢Á Production and management of adult stem cells used in research
¢Á Production and management of adult stem cells used in clinical trials
¢Á Quality control of adult stem cell therapeutics
(sterility test, mycoplasma test, in vitro viral test, endotoxin test, identity test, purity
test, potency test and viability and content test)
¢Á Provision of documents submitted to the Korea Food & Drug Administration and
proxy for the approval of clinical trials
(safety, documents in relation to validity, standard and test method related
documents, etc)
¢Á Provision of other stem cell related research service
(Marrow stromal stem cell, Hematopoietic stem cell, Adipose cell etc.) |
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Our company holds patents (patent registered in South Korea and Europe) in the manufacturing techniques of dendritic cell from hematopoietic stem cell and neural cell from marrow stromal stem cell. In 2005, after passing the Korea Food & Drug Administration's cell therapeutics manufactory facility standards, we have produced numerous cells for clinical trial use while supplying researchers. |
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In addition, we are also currently performing a specialized consigned manufacturing of lipocyte derived stem cell for external surgery. The company's 100 pyeong manufactory facility, numerous cell treatment equipments and skilled staff enable us to produce the finest cell with the best technology. |
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In order to maintain safety and consistency in cell quality, we have established quality control regulations on the items below that have been set in the necessary standard and testing method (Evaluation regulations for evaluation request letter and standard and testing method for medical supplies etc, Korea Food & Drug Administration notice no. 2003-60). Further, these regulations are applied during the final production process to produce the highest quality cell therapeutics.
¢Á sterility test
¢Á mycoplasma test
¢Á in vitro viral test
¢Á endotoxin test
¢Á identity test
¢Á purity test
¢Á potency test
¢Á viability and content
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Furthermore, in order to perfect production in our cell therapeutics, we are practicing endotoxin tests and microbial test (asepsis and mycoplasma test) with mediums, additives and buffer solutions used in the production of cell therapeutics as test objects. |
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FCB-Pharmicell Cell Treatment
Research Institute
Chief Researcher Yong Man Kim
+82.31.777.9340 Extension 103
E-mail : kimy@fcbpharmicell.com |
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FCB-Pharmicell Co.,Ltd. 920 Sicox Tower 513-14, Sangdaewon1-dong, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
¤ýT.82.31.777.9340 ¤ýF. 82.31.777.9343
COPYRIGHT(C) 2007 FCB-PHAMICELL CO.,Ltd. ALL RIGHTS RESERVED. |
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