Supporting practical applications of stem cell and regenerative medicine research National Center for Stem Cell and Regenerative Medicine National Stem Cell Research Infrastructure Procedure for GMP Manufacturing Facility Use GMP Equipment and Quality System Location GMP Manufacturing Service Requirements to Apply Researchers with capacities in clinical studies and the development of advanced therapy medicinal products in regenerative healthcare fields · Verified safety and efficacy of products at GLP facilities · Completed the GMP manufacturing process and analytical methods · Period of manufacturing processes not exceeding nine (9) months · Able to start clinical study within one year after finishing manufacturing of products Criteria of Approval · Suitability of Utilization Plan · Competency of Processing Techniques · Possibility of Practical Application · Relevance of Outcome Utilization · Ripple Effect of Regenerative Medicine Fees of Service Minimum price to reduce the cost burden of users http://nih.go.kr/ncsr 질병관리청 국립줄기세포재생센터 202 Osongsaengmyung 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28160, Korea Division of Intractable Disease Research TEL . +82-43-249-2533 FAX . +82-43-249-2548 National Center For Stem Cell And Regenerative Medicine Time to Apply Anytime throughout the year Division of Intractable Disease Research e-mail [email protected] Phone +82-43-249-2533 ※ Contact : We use this GMP facility to manufacture and supply researcher's investigation cell therapy drug for clinical phase 1 or phase 1/2a National Institute of Health Republic of Korea National Institute of Health Republic of Korea GMP Quality System Level 4 Level 3 Level 2 Level 1 Related Quality Documents and Records Standard Operating Procedure Quality Policy Quality Manual Steps to Apply 1 2 3 4 Interview Pre-review Review and Approval Contract by e-mailing, calling or visiting Review of Utilization Plan(Draft) Registration and Evaluation of Utilization Plan (by 10 Review Board Members) Contract signing and provision of GMP Services (Post-monitoring of service goals) Step Process Major GMP Equipment Division Species Amounts Utility HVAC System, Gas System, BMS, TMS, PMS, LN2 System, etc. 45 Process BSC, CO2 Incubator, Centrifuge, RP Microscope, CRF, etc. 104 QC Fluorescent Microscope, FACS, Endotoxin Analyser, RT-PCR, Cytometer, NAE, Air Particle Counter, Air Sampler, etc. 70 Storage LN2 Tank, Cell Storage Tank, Deep Freezer, Refrigerator, Freezer, etc. 23 Total 242