![4 2016MAR Confidential
Located in Hsinchu Science Park,Taiwan
(110 km south ofTaipei)
• Company established: Sep. 2001
• Facility built/validation: 2004
• Chairman: Te-Li Chen, M.D., Ph.D
• President: KarenWen, Ph.D.
• Employees: 121
• Main business activities: CDMO service
Biological product development
• Capital: USD 37 million (NTD 1.1 billion)
• Net sales: USD 4.5 million [NTD 134.9 million, year 2015]
• Listed on the GreTai Securities Market (GTSM),Taiwan # 4726](https://image.slidesharecdn.com/5e810cf0-5405-45b1-934a-cc1676b40c92-160324054850/85/Mycenax-Introduction_-4-320.jpg)
Mycenax Introduction_
- 1. From Bench to Better Lives 1 2016MAR Confidential Mycenax Biotech Inc. 2016 March
- 2. • Mycenax in Brief • CDMO Capability and Capacity for Biologics Development • Biosimilar Pipeline • Summary 2016MAR Confidential2 Outline
- 4. 4 2016MAR Confidential Located in Hsinchu Science Park,Taiwan (110 km south ofTaipei) • Company established: Sep. 2001 • Facility built/validation: 2004 • Chairman: Te-Li Chen, M.D., Ph.D • President: KarenWen, Ph.D. • Employees: 121 • Main business activities: CDMO service Biological product development • Capital: USD 37 million (NTD 1.1 billion) • Net sales: USD 4.5 million [NTD 134.9 million, year 2015] • Listed on the GreTai Securities Market (GTSM),Taiwan # 4726
- 5. 2016MAR Confidential5 • Expertise in biologics manufacturing • PIC/S GMP certified and FDA DMF registered • Mammalian and Microbial manufacturing according to EMA/FDA/JP/ICH guidelines • A total service solution from cell line development to aseptic fill/finish • Disposable technology with up to 2000L scale • Mycenax has 7 biosimilars in its pipeline and is intensively evaluating bionovel opportunities. A CDMO provider, Biosimilar Partner & Bionovel Co-developer
- 6. Core Competency - Bioprocess 2016MAR Confidential6 Meeting International Standards & Client Expections
- 7. 2016MAR Confidential7 Bionovel Monoclonal antibody Therapeutic vaccine Recombinant protein Nasal vaccine Glycoprotein Transgenic protein DNA vaccine Biosimilar Monoclonal antibody Fc-fusion protein Recombinant protein Peptide Worldwide partnership
- 8. 2016/3/21 Confidential8 Bench Bed Better life Track Records Mab-BS Mab-BS Registration,TW Recombinant Protein Phase I~III,TW/ KR TuNEX® Phase I IND, EU/TW Peptide Drug GranNEX® LusiNEX® Mab Phase II~III, US/KR/TW/HK/IN OncologyVaccine Phase II, Global Recombinant Flu Vaccine Bionovel Recombinant protein Therapeutic vaccine Monoclonal antibody Nasal vaccine Glycoprotein Transgenic protein DNA vaccine Biosimilar Monoclonal antibody Recombinant peptide
- 9. Project Management Process Development Cell line Upstream (fermentation/ cell culture) Downstream (purification/ formulation) Analytical development PIC/S GMP manufacture Cell bank production (MCB/WCB) Upstream mfg. Downstream mfg. Stability Study Quality Assurance Aseptic Fill/Finish Vial Filling Lyophilization Prefilled Syringe (PFS) Characterization Analysis Product characterization Comparability study CMC writing CTD package (Module 3) IND/NDA submission 2016MAR Confidential9 Total Solution for Protein Drug Development -CMC based platform, DisposableTechnology and PIC/S GMP manufacturing
- 10. Mammalian system-5, 50, 200, 500, 2000L Microbial system- 5, 50L 2016MAR Confidential10 200LModel Establishment Confirmation (CQA)Testing run (KPP) 500L Model Establishment Confirmation (CQA)Testing run (KPP) 2,000LModel Establishment Confirmation (CQA)Testing run (KPP) Upstream Process Development -Scale up to designate process 5LBioreactor Model Establishment Medium/Feed selection Process optimization Feeding strategy Glycan Modulation (option) Clone selection 50LModel Establishment Confirmation (CQA) Testing run (KPP)
- 11. • Excipients and conditions screening: to define a formulation development strategy (Buffer system, pH, stabilizer, tonicity modifier etc.) • Physiochemical characterization • Developing stability-indicating analytical method • Accelerated studies Bench Scale Pilot Scale Commercial Scale Downstream Process Development - Bench scale/ Pilot scale/ Commercial scale - Cost, CQA, Stability, Recovery 11 Material for Downstream Capture Purification Intermediate Purification Polishing Virus Clearance Formulation Drug Substance Formulation Development • Column scale (ID)= 5 ~ 50 mm • Column scale (ID)= 26 ~ 140 mm • Column scale (ID)= 70~ 630 mm Confidential2016MAR
- 12. Fill/Finishing Service Aseptic Filtration and Filling • Material of filter membrane selection • Liquid Filling: Max. Batch Size = 1500~5000 vials (2R~20R) • Lyophilization Filling: Max. Batch Size = 3200 vials (2R) • Pre-filled Syringe : Max. Batch Size = 4000 syringes Labeling and Packaging • Product labeling • Product re-labeling • ClinicalTrial Material (CTM) assembly/packaging/labeling 2016MAR Confidential12 Drug Product Production- Aseptic Fill/Finishing
- 13. 2016MAR Confidential13 • Cell based bioactivity assay – Proliferation – CDC – cAMP – Cytotoxicity • Neutralization assay • Binding assay Protein Analysis and Characterization • LC-MS for Full sequence, N- terminal sequence, C-terminal sequence, PTM, glycosylation site, glycan structure, and Disulfide linkage, • Secondary structure by CD and FT-IR • NMR or X-ray crystallography for higher order structures • Identity by SDS-PAGE • Charge variants by IEF, cIEF, CZE • Size variants by SDS-PAGE, • Immunochemical properties byWB, • Carbohydrate by monosaccharides analysis and glycan analysis, • Amino acid composition analysis • Sterility • Bioburden • Endotoxin • pH • Conductivity • Liquid Particulate matter • TOC • Removable volume • Uniformity-WV • Water content • Osmolality• HPLC – Size exclusion – Reverse phase – Ion exchange – Hydrophobic interaction • CE-SDS • Process related impurity – Host cell protein – Host DNA – Triton X-100 – Imidazole – Insulin – Protein A residue – Heparin residues • Peptide mapping • SDS-PAGE • Western Blot • IEF/ cIEF • UV absorbance • ELISA • BCA/ Bradford/ Lowry assay • HPLC – Affinity – Reverse phase • Formulation content – Detergent – Preservative Physicochemical and Immunological Properties Purity and Impurities Content Potency/ Bioassay Identity PharmacopeiaStructural Characterization
- 14. 33 2016MAR Confidential Production Process / Analytical Method Development Mycenax generic platform for monoclonal antibody drugs Upstream process development Mammalian cell culture Process development: 5 L stir tank and ambr system Scale-up and GMP production: 50/200/500/2000 L single use bioreactor Microbial fermentation Process development: 7.5 L stir tank Scale-up and GMP production: 50 L single use bioreactor Downstream process development Purification process research Formulation research Analytical method development/qualification/validation Characterization and comparability study PIC/S GMP manufacturing Master / Working cell banking GMP manufacturing Aseptic fill/finishing Liquid in vial Liquid in prefilled syringe (PFS) Lyophilization in vial CTD package (Module 3- CMC) IND/NDA submission
- 15. Biosimilar Pipeline 2016MAR Confidential15 Applying Mycenax Expertise to Biological Drug Development
- 16. Project Originator Cell clone Pre-IND Phase I Phase II Phase III Market TuNEX® Etanercept-similar Enbrel® LusiNEX Tocilizumab-similar Actemra® *Adalimumab-similar Humira® Omalizumab-similar Xolair® AiNEX Bevacizumab-similar Avastin® *Trastuzumab-similar Herceptin® *Cetuximab-similar Erbitux® GranNEX Filgrastim-similar Neupogen® AutoimmuneOncology Launch in 2017 IND filing in 2017 * : Cooperate with TPG Biologics, Inc. 2016MAR Pipelines Confidential16
- 17. Summary 2016MAR Confidential17 What Mycenax Can Do forYou
- 18. 2016MAR Confidential18 • Mycenax focused on developing quality and cost competitive platforms for biological drug development • A total solution for protein drug development by using disposable technology in PIC/S GMP certified facility. • Disposable technology with up to 2000L scale. As a CDMO Provider • Aggressively evaluating Bionovels. • Mycenax partners with biopharmaceuticals, especially for BIO CMC development and M&S. As a Biosimilar Partner and Bionovel Codeveloper SatisfyYour Needs
- 19. From Bench to Better Lives 2016MAR Confidential19