Technology for Life 1

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Willis Flynn
7 years ago
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1 Technology for Life 1

2 Who we are Global supplier of custom manufactured API s and Intermediates Established in December 10, 1948 Turnover: USD 100M (Oct to Sep. 2016) Number of Workers: 325 2

3 Locations 3

4 Custom Chemical Manufacturing Technology More than 60 different synthesis reactions at commercial scale Strengths: Unnatural Amino Acids Long Chain Peptides Optically Active Compounds 4

5 A look back to the beginning Corporate Entities 1948 founding of Hamari Physicochemical Research Laboratory (closed) 1950 founding of Hamari Chemicals, Ltd., Sakai facility (closed) 1955 founding of Hamari Chemicals, Ltd., Tokyo Office 1961 founding of Hamari Chemicals, Ltd., Takatsuki facility (closed) 1974 founding of Hamari Company Ltd. ( Hamari Health ) 1975 founding of Hamari Chemicals, Ltd., Osaka facility 1980 founding of Yonezawa Hamari Chemicals, Ltd founding of Hamari Chemicals USA Inc founding of Kobe Research Center 2011 founding of Hamari Chemicals USA Inc. San Diego Research Center 2013 founding of Chitose Hamari Chemicals, Ltd. 5

6 A look back to the beginning Historical Active Ingredients 1968 first peptide at commercial scale: L-Glycyl L-Glycine 1984 first US patent: Diltiazem 1985 first US-FDA approved Active Pharmaceutical Ingredient: Ibuprofen 2002 first US-FDA approved New Dietary Ingredient: Zinc Carnosine 2006 first Russia (MHSDRF) approved API: Benfotiamine 2010 first Ukraine (MHU) approved API: Benfotiamine 2012 first India (DCGI) approved API: Benfotiamine 2015 first Australia (TGA) approved API: Zinc Carnosine 6

7 A look back to the beginning Facility Improvements 2008 establishment of high-potency lab and kilo-lab at Osaka facility 2015 establishment of high-potency facility at Chitose facility 2016 recent US-FDA Inspection closure at Yonezawa facility Awards, Certifications and Programs 2013 Kansai Quality Award Winner, Improvement Award 2014 Kansai Quality Award Winner, Award for Excellence 2001 ISO Certification, Yonezawa facility 2011 Kosher Certification 2016 Manufacturing/marketing business license for drugs, Japan Corporate Programs: Corporate Identity (2005); Group QA (2009) ; 5S Housekeeping and Improvement Campaign, Yonezawa facility (1992), Osaka facility (1995), Chitose facility (2014) 7

8 Sales Share by Product Sales volume: 100 million USD Cosmetics & Nutrition Ingredients (9%) Intermediates (13%) Others (7%) Plant Extracts (3%) Active Pharmaceutical Ingredients (68%) 8

9 Sales Share by Region Domestic, Japan (81%) International (19%) Americas (8%) Africa (4%) Russia & Asia (33%) Europe (54%) 9

10 Food Supplement Products Sold in the US Hamari has been supplying food supplement ingredients to the US market for over than 20 years. Chemical Name Zinc Carnosine (L-Carnosine Zinc complex) Benfotiamine (Vitamin B1 derivative) L- Carnosine PepzinGI BenfoPure CarnoLife (β-alanyl-l-histidine) 10

11 Nutraceuticals/Cosmeceuticals OTC Products/Natural Extracts Generic Pharmaceuticals Novel Pharmaceuticals University Technology Licensing Organization Bio-Venture 11

12 Organizational chart of Hamari Group Hamari HQ Yonezawa Hamari Chitose Hamari President Board Members QA Dept. Purchasing Dept. International Dept. Plant Manager Plant Manager Manufacturing Dept. QA Section QC Section Shanghai Office R & D Dept. Group 1 Group 2 Group 3 Group 4 Kobe Lab. Sales &Marketing Dept. Section 1 Section 2 Hamari USA Project Management Office Technology Dept. No.1 Section No. 2 Section No. 3 Section QA Dept. Manufacturing Dept. EHS Office QA Section QC Section Material Management Section Production Management Dept. Manufacturing Dept. Environment Control Dept. QA Dept. QA Section QC Section Engineering & Maintenance Section Packaging & Labeling Section Engineering & Maintenance Section 12

13 Number of Workers Sales R&D QC QA Manuf. Hamari USA (SDRC) Hamari Chemicals Chitose Hamari Yonezawa Hamari

14 Site Function and Business Flow Customer New enquiry! Business Development Hamari USA Hamari Chemicals Hamari Chemicals Chitose Hamari Yonezawa Hamari QC/QA R&D Synthesis & Analysis Hamari USA Hamari Chemicals Yonezawa Hamari Manufacture Hamari Chemicals Chitose Hamari Yonezawa Hamari 14

15 Production Scale <Development Timeline for Pharmaceuticals> Preclinical Clinical Commercial Hamari USA Hamari Chemicals Chitose Hamari Yonezawa Hamari Lab Synthesis (gram to kilo gram scale) Lab, Pilot, Scale up, PQ and PV manufacture (gram to 100kg) Pilot, Scale up, PQ, PV and Commercial manufacture (50 kg to 200 kg) - Synthesis Route Development - Target Compound Synthesis - Synthesis of Samples - (Analysis Development) - Process Optimization - Kilogram Scale Manufacture - GMP Manufacture - Analysis Development and Validation - PQ and PV Manufacture - Drug Master File - Approval Inspection - Commercial Production 15

16 Facilities (1) Osaka Size: 1970 m 2 Waste Water: incineration, public sewage treatment Water: potable, deionized Low Temperature cooling system Total Reactor Capacity: > 21 m 3 Reactors: 50L to 2000L, 17 GL, 10 SUS Low Temp.: -20 C High Temp.: 150 C Autoclaves: 3 reactors at 0.96 MPa (SUS 100L, 500L, Hastelloy 500L) Controlled Areas: 2 lines (200L, 1000L) High potency Lab OEL 4 Lyophilizer 16

17 Facilities (2) Yonezawa Size: 52,806 m 2 Waste Water: incineration, self-process Water: potable, purified, deionized Total Reactor Capacity: >270 m 3 Reactors: 50L to 5000L {72 x GL(148m 3 ); 75 x SUS(123m 3 )} Low Temp.: -90 C High Temp.: 150 C Purification column: 5000L x 2, 2500L x 3, 1200L, 700L x 2, 500L, 250L x 6 Autoclaves: 1 reactor at 0.2 MPa (SUS 1000L); 4 reactors at 0.96 MPa (300L to 2500L); 1 reactor at 6.8 MPa (SUS 500L) Controlled Areas: 4 areas (200L, 800L, 1000L, 2000L, 3000L) Spray Dryer 17

18 Facilities (3) Yonezawa API Plant 18

19 Facilities (4) Chitose Size: 8,000 m 2 Land Size: 56,760 m 2 Water: potable, purified, deionized Acquisition Date: 2013 Total Reactor Capacity: >20 m 3 Reactors: 14 x GL (15 m 3 ); 6 x SUS (4.6 m 3 ) Autoclave: at 6.0 MPa (Hastelloy 300L) Dedicated facility for peptides, high potency facility OEL 4 19

20 Facilities (5) Hamari USA Inc. San Diego Research Center Synthetic Route Scouting Size: 608 m 2 Twelve 8 hoods Two 8 walk-in hoods 5 to 50 L jacketed reactors Parr hydrogenator and autoclave Onsite LC/MS, HPLC and NMR CHIRALPACK 1A, 1B, 1C, 1D and 1E columns Combi-Flash automatic chromatography Custom Peptide Synthesis (LPPS / SPPS / Biotage Microwave Peptide Synthesizer) Access to FTIR, TGA, DSC, XRD 20

21 Audit Experience ( ) from Regulatory Authority 12 from Non-Japanese Clients 9 from Japanese Clients 59 21

22 Clinical Trial Products (IND manufacturing in ) for Non-Japanese Clients 2 for Japanese Clients 19 22

23 DMF s Held by Hamari Quantity Year US DMF , 2009 Europe DMF Korea DMF , 2006, 2008 Japan DMF 27 - Client's DMF 6-23

Brand Quality with Asian Advantages

Brand Quality with Asian Advantages ScinoPharm Taiwan, Ltd. No.1, Nan-Ke 8th Road, Tainan Science Park, Shan-Hua, Tainan, 74144, Taiwan TEL : 886-6-505-2888 FAX : 886-6-505-2898 Email Contact : mkt@scinopharm.com