www.kbiohealth.kr 바이오의약생산센터 Bio Pharmaceuticals Manufacturing Center
오송첨단의료산업진흥센터바이오의약생산센터 세계와경쟁하는바이오의약품제조전문센터 2015 GMP GMP Quality by Design QbD 2016 3 KGMP 2019 One Stop Service EU GMP 2
www.kbiohealth.kr The globally competitive center specialized for biopharmaceutical manufacturing of KBIO was built to serve biopharmaceutical companies and research institutions having difficulties with establishing their own biopharmaceutical manufacturing facilities We are here to promote the development of new biopharmaceuticals and to increase their success Since the center completed its GMP system we have provided services such as manufacturing process development analysis support GMP consulting and education for biopharmaceutical industry in Korea We also play an important role among the leading institutions of QbD Quality by Design guideline for biopharmaceuticals manufacturing Since the has Korean GMP approval in 2016 for biopharmaceuticals manufacturing plant the manufacturing volume is increasing We will strive to offer one stop manufacturing service from substance to finished products since 2019 and to comply with EU GMP guidelines so that Bio Pharmaceuticals manufacturing Center will be the birthplace of the new global drugs 3
오송첨단의료산업진흥센터바이오의약생산센터 시설현황 3 981 46 2 1 807 20 1 1 703 36 1 1 198 74 5 691 4
www.kbiohealth.kr Facilities Classification Area Main facilities Third floor 981 46 HVAC Heating Ventilation Air Conditioning System Second floor First floor Basement 1 807 20 1 703 36 1 198 74 Inoculation Cell Culture Purification Media Buffer Preparation Bulk Filling In process Control Washing Process Control Process Development Lab Quality Control Lab Central Control Station Warehouse Office Utility System Water for Injection Purified Water Pure Steam Compressed Air Bio Kill System Total floor area 5 691 5
오송첨단의료산업진흥센터바이오의약생산센터 연혁 2008 03 2009 08 2011 04 2013 11 2014 10 2015 12 2016 01 2016 03 2016 04 2017 07 2 QbD GMP GMP 설립목적 비전및목표 GMP One Stop Service 핵심전략 cgmp EU GMP PIC S GMP GMP GMP 6
www.kbiohealth.kr History Mar 2008 Aug 2009 Apr 2011 Nov 2013 Oct 2014 Dec 2015 Jan 2016 Mar 2016 Apr 2016 July 2017 The Law on Identification and Support of the High Tech Medical Cluster has been enacted Decided to locate the High Tech Medical Cluster in Osong Jae Hwan Kim assumed the first chief directorship of the Clinical Drug Manufacturing Center Complete the construction of the Clinical Drug Manufacturing Center Osong Medical Innovation Foundation Kyu Ho Bang assumed the second chief directorship of the Clinical Drug Manufacturing Center Participate QbD Quality by Design model development for biopharmaceutical manufacturing The Law on Identification and Support of the High Tech Medical Cluster has been changed Permitting manufacturing commercial drugs KGMP compliance for manufacturing Biopharmaceutical drug substances was approved by FDS Daejeon Regional Office as the GMP training center by pharmacy schools Change the name of Clinical Drug Manufacturing Center to Biopharmaceuticals Manufacturing Center Mission This organization s mission is to promote the development of new biopharmaceuticals by manufacturing and supplying the biopharmaceutical products to pharmaceutical companies and research institutions having difficulties in establishing and operating manufacturing facilities for biopharmaceutical products antiboby drugs and recombinant biopharmaceuticals through animal cell culture Vision & Goal Vision The globally competitive center specialized for biopharmaceutical manufacturing Goal Manufacturing biopharmaceuticals in compliance with GMP standards One Stop Service from manufacturing non clinical product to supporting commercialization Core Strategy Building production facilities in compliance with cgmp EU GMP and PIC S Enhancing vitalizations of domestic new biomedicine development by building production facilities complying with GMP standard in order to enter the global market Supporting for strengthening domestic biomedicine enterprise ability Cultivating global experts GMP Facility and quality system consultation Supporting for IND and NDA process Building domestic and international networks 7
오송첨단의료산업진흥센터바이오의약생산센터 조직및역할 센터장 GMP BM PM CMO Cell Bank Scale up Process Pre Filled Syringe R D GMP GMP 8
www.kbiohealth.kr Organization & Role Chief director Dept of Strategy Administration Dept of Manufacturing Support Dept of Manufacturing R D and Strategic Planning Team Business Administration Team Maintenance Engineering Team Production Support Team Production Team Process Development Team Dept of Quality management Quality Assurance Team Quality Control Team Department Chief director Dept of Strategy Administration R BD and Strategic Planning Team Business Administration Team Dept of Manufacturing Support Maintenance Engineering Team Production Support Team Dept of Manufacturing Production Team Process Development Team Dept of Quality Management Quality Assurance Quality Control Functions General responsibilities for operational management research planning and execution management Business and R D planning public relations and administrative support Business and R D planning public relations PR GMP Education Human resources general affairs budgeting accounting general administration Manufactuirng support and facility maintenance Equipment and facility management BM PM Calibration CMO contract management purchase stocking and storage management of raw material and product Manufacturing of drug substances and finished drug products Cell bank manufacturing Manufacturing of drug substance through animal cell cultivation purification and scale up process and manufacturing of finished products liquid vials and pre filled syringes Manufacturing process development R D planning and execution tech transfer GMP quality systems operation and quality control support Establishment and operation of GMP quality system including standard operating procedure SOP Testing for raw materials intermediates and finished products Stability study etc environmental monitoring and validation of analytical procedure 9
오송첨단의료산업진흥센터바이오의약생산센터 지원사업 1 2015 2020 2019 2 3 4 GMP 5 6 R D 1 2 3 임상용 ~ 상업용바이오의약품생산지원 GMP GMP KGMP 2016 3 QbD CMC GMP 10L 50L Single Use 200 1000L Multi Use 100 500L 10
www.kbiohealth.kr Supporting business 1 Produce diverse bio pharmaceuticals in compliance with CGMP Drug substance Animal cell culture 2015 Cell Gene Therapy 2020 Drug product Liquid vials Pre filled syringes construction in process 2 Process development optimization Animal cell culture and purification process optimization 3 Analytical procedure development and analysis Analysis of biopharmaceuticals stability test etc 4 GMP consulting 5 GMP Education for pharmaceutical industry 6 Support IND NDA BLA process Basic R D New Drug Development Center Support the bio pharmaceutical development and manufacturing Basic Research Preliminary Research Non Clinical Experiment Clinical Phases I II and III Registration Manufacture and Sale Production of Non Clinical Drug Production of Clinical Drug Technology Service Regulatory Support Support for the production of biopharmaceutical products GMP system construction and approval GMP system construction KGMP approval Implementation of Quality by Design QbD program for pharmaceuticals Establishment of support system for IND dossier preparation GMP services Manufacturing of biopharmaceuticals Non clinical Clinical Commercial trials 10L 50L Single Use 200 1000L Multi Use 100 500L Quality Control Providing analytical test services such as drug release and stability test 11
오송첨단의료산업진흥센터바이오의약생산센터 제조공정개발지원 Scale Control processor Scale Up 2 50L 2L 10L 50L 100L 500L 1 000L Labscale 10L 200L 2 3 7 UF DF Scale up ÄKTA system Scale up AKTA FPLC avante pilot process 6 10mm 분석법개발및분석지원 Cell line Media Water HVAC Monitoring 12
www.kbiohealth.kr Support for the development of manufacturing process Upstream Process Standard Cell culture process Application of identical process controller throughout the entire scale Development of a Scale Up process 2 50L 2L 10L 50L 100L 500L 1 000L Labscale 10L 200L Downstream Process Standard 2 or 3 column process Scale up of UF DF up to 200L Linear scale up by AKTA system AKTA FPLC avante pilot process 6 10mm Development of analytical procedure and analysis support Supporting the method development Development and optimization of analytical procedure for biopharmaceutical products Raw material test Batch release test Method Validation Stability study Identification test Cell line Purity test Media Impurity test Excipients additives Assay of content Assay of potency Sterility test Specificity Accuracy Precision Linearity Range Robustness Long term stability Accelerated stability Stress test Environemental Monitoring Water HVAC Monitoring 13
오송첨단의료산업진흥센터바이오의약생산센터 GMP 컨설팅 GMP GMP GMP GAP URS SIA QRA Commissioning Qualification GMP SOP GMP GAP GMP GMP GMP GMP GMP 바이오의약품전문가양성 배양 / 분리정제품질보증 / 관리인허가 현장밀착형기술교육을통한기업수요맞춤형전문인력양성 선제적 GMP 교육을통한사업화연계연구개발강화 의약바이오산업체를위한우수예비인력양성 임상및품목허가프로세스지원 Customer ICH Guideline CTD Format CMC CMC CTD Common Technical Document CMC Chemistry Manufacturing and Control 14
www.kbiohealth.kr GMP Consultation GMP facility construction Visiting services Customizing services Establishment of the GMP quality system Operation of the GMP quality System Conceptual design GMP quality document system Detailed design and GAP SOP and relevant document analysis forms URS preparation Documentation and Records System Impact Education and Training Assessment SIA Gap analysis between GMP Quality Risk Assessment QRA quality documents and relevant Commissioning document regulations Qualification document Others Others Implementation of auditing Constitution of GMP organization job descriptions GMP training Qualification and validation Management of GMP documents records Management of GMP facilities Change control and deviation control Contract management GMP hygiene control Others Training experts for biopharmaceutical field Strengthening technical human resources in the fields of biopharmaceutical industries for global competitiveness Cell culture purification Quality assurance control Authorization approval Training of customized experts to satisfy corporate demands through field adhered technical practice Enhancement of Commercialization linked R D through preliminary GMP training Cultivation and supply superb reserve human resources for biopharmaceutical companies Support IND and NDA approval processes Customer Development materials for candidate substances Bio Pharmaceuticals Manufacturing Center Support IND and NDA dossiers Prepare the CMC part among CTD formats in compliance with the ICH Guideline Ministry of Food and Drug Safety IND NDA Approval Principal CMC contents Drug substances Data for manufacturing validation quality characteristics control of drug substances reference standard containers and packaging stability and others Drug products Data for manufacturing validation control of additives excipients control of drug products reference standard containers and packaging stability and placebo or control drugs CTD International Common Technical Document CMC Chemistry Manufacturing and Control 15
오송첨단의료산업진흥재단바이오의약생산센터 충청북도 C&V 센터 오송보건의료행정타운식품의약품안전처 CJ 오송공장 오창 옥산 서울 LG 생명과학오송캠퍼스 힐데스하임 두산위브센티움 한화캐미칼오송공장 연제저수지 ( 돌다리못 ) KTX 오송역 오송상록롯데캐슬 만수교차로오송휴먼시아 궁평교차로 궁평지하차도 미호천교 월곡사거리 서청주 IC ( 중부고속도로 ) 36 청주 IC ( 경부고속도로 ) IC 36 IC 36 36 KTX 5 20 BUS 53 57 500 511 525 750 751 53 525 1 3 15 20 18 50 17 10 19 25 06 45 28160 123 123 Osongsaengmyung ro Osong eub Heungdeok gu Cheongju si Chungbuk 28160 Republic of Korea www kbiohealth kr Tel 82 43 200 9932 Fax 82 43 200 9902 Mail jwj@kbiohealth kr