Introduction of Development Center for Biotechnology TAIWAN
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1 Introduction of Development Center for Biotechnology TAIWAN
2 DCB Nonprofit Organization Founded in 1984 Funded Mainly by Ministry of Economic Affairs (MOEA), National Science Council and the Industry 394 Employees (16% Ph.D., 59% MS) M.S.) 2
3 Uniqueness Protein Drug Antibody Application Manufacturing u gservice Preclinical Development Integrated Capability Academia-Industry Linkage Business Promotion o o Technology Commercialization Coordination & Incubation 3
4 Protein Drug / Antibody Application Based on Various Antibody Technology Platforms: Antibody Humanization & Optimization i Bispecific Antibody Chinese Patients Antibody Libraries High-Yield Cell Engineering Anti-CD3 Anti-tumor antigen Bispecific Antibody Platform Develop Proprietary Therapeutic Antibodies: Disease Areas Covered: Anti-IL-20 mab, IND (2013) Anti-HSV mab, IND (2015) Cancer, Immunological Disorder, Viral Infection 4
5 Protein Drug / Vaccine Platform Vaccine Development with Novel Adjuvant (LT) LT-Hib: Haemophilus Influenzae Type B(Hib)V Vaccine Tech Transfer: Tuckmore LT-Flu: Nasal Spray Flu Vaccine Clinical Phase I Trial (Approved by TFDA on ) 5
6 Protein Drug / Manufacturing Service CGMP Biopharmaceutical Pilot Plant Facility Mammalian cell culture production of biologics for clinical Phase I/II trials cgmp certificate by DOH, TAIWAN FDA Drug Master File (No ) PIC/S international cgmp compliance BioPharma Asia s s Best CMO Award (2011) 6
7 Biopharmaceutical Plant / Track Record Mammalian Cells Cell line experience including CHO, NS0, and PER.C6. Prior monoclonal antibody project experience, including Anti-IL 20, Anti-HSV, Anti-TNFα, Rituxan Monoclonal antibody project for EU consultation GMP production of fusion proteins, 500L scale, for US FDA pre-ind Microbial Cells Protein complex for US FDA pre- IND and TFDA IND approvals Customized GMP production of pegylated recombinant proteins IND approval in Taiwan, USA and dcanada Phase I (Canada) finished in 2010 Phase II clinical material to client (Oct. 2011) IND filing of biosimilarsi il in USA and Canada (Oct. 2011) IND filing of protein vaccines in Taiwan (Dec. 2011) 7
8 Protein Drug / Safety Testing GLP Testing Facility for Biological Safety Cell Bank Characterization Bulk & Lot Release Testing Virus Clearance Validation Bioassay Development Clinical Sample Analysis Certifications TFDA GLP TAF OECD GLP ISO In vitro / In vivo Lab P2+ Lab P2 In vitro Lab P2 Animal Facility Bacterial Lab R&D Lab Alliance Partners ATIT Vitrology (Acquired by SGS) Recent Case : 510(K) Accreditation ti for Biogenic i Technology, Inc. University of Queensland 8 8
9 Preclinical Development / Integrated Capability Target & Lead Lead Preclinical IND Clinical Trials NDA Market Discovery Optimization Evaluation Phase I, II, III Launch Drug Design & Synthesis Animal Pharmacology Formulation DM/PK (ADME) Toxicity Testing GMP Production IND core-team integrates chemistry, biology, pharmacology, toxicology etc. Receive drug leads from academia & industry and optimize into drug-like candidates for IND filing and entry into clinical stage 9
10 Prof. M.S. Chang Preclinical Development / Academia-Industry Linkage Anti-IL-20 mab Target & Lead Lead Preclinical IND Clinical Trials Discovery Optimization Evaluation Phase I, II, III NDA Market Launch Humanization In vitro Assays Development ( ) Affinity it Maturation ti Pharmacokinetic Studies ( ) Processes Development ( ) Analytical Methods Development ( ) Cell-Line Development ( ) & 7E DCBPR0801 Characterization Mouse mab Humanized mab Bio-Safety Testing (Kd:7.81E-10 M) (Kd:2.88E-10 M) Toxicity & Immunogenicity Tests Indication: cgmp Production Rheumatoid Arthritis IND Application 10
11 Thank You DCB Website w 11
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