Company Overview and Products & Services

Transcription

1 Company verview and Products & Services

2 amari Chemicals - Content 1. amari Chemicals: Company verview 2. ur Products & Services Peptides R&D Services Manufacturing Services

3 Corporate istory 1948 amari Chemicals, Ltd. established 1980 Yonezawa Plant opened 1982 Process of Diltiazem * Cl was world wide patented (US ) also published as follows: A Simple Ring-expansion of 1,4-Benzothiazines to give 1,5-Benzothiazepines. Benzothiazepines. (J. Chem. Soc., Chem. Commun. 1983, 450.) 1994 Polaprezinc as original drug was world wide patented (US , CA , EP303380) 2001 IS Certification received 2001 USA office opened 2005 China (Shanghai) office opened 2008 amari USA inc. (Portland, r.) and Europe (Frankfurt am Main - Germany) offices opened

4 Capabilities & Strengths Drug Discovery Pre-Clinical Study Investigational ew Drug Clinical Phase Commercial Production ew Drug Application

5 Global Presence amari USA Inc. Portland, R Japan Commercial Manufacturing Plant/ R&D lab. Yonezawa Europe ffice Frankfurt, Germany China ffice Shanghai Japan Q Pilot plant/ R&D Center saka Tokyo Branch Kobe Laboratory

6 Commercial Plant Yonezawa Size m 2 Total >240m 3 reactor capacity from liter 12 independent product lines Kg scale lab

7 Commercial Plant API plant (building no. 3) Glass-lined 5 Stainless Steel 12 auta Dryer 2 Autoclave (1Mpa) 2500L

8 igh potency <50g

9 Quality Audit Experience Inspection by FDA 1985 first FDA approved product: Ibuprofen 1997 PAI for one item 2006 PAI for two items 2012 expect 3 PAIs Inspection by Global and Japanese Pharmaceutical Clients Multiple inspections per month

10 amari Chemicals Prod. & Serv. 2. ur Products & Services Peptides R&D services Manufacturing services

11 Peptides Application APIs (and Intermediates) Cosmetics uman nutrition Chemicals

12 R&D Services Full range of R&D Services Process development and optimization for scale up Process validation Analytical methods development and validation Stability studies

13 Expertise More than 50 years of experience in peptide synthesis. C 2 L-Carnosine 2 2 Tfa Tfa-Lys-Pro C 2 2 Me 2 Ala-is-Lys C 2 Zn 2 Polaprezinc - API in Japan - Dietary supplement in USA n Capacity / kg to ton scale Capacity (maximum per year) di-peptide : 50 tons tri peptide : 20 tons tetra, penta peptide : 10 tons hexa-peptide : 5 tons

14 Expertise ACE Inhibitors Lisinopril ester (Europe) C 2 5 Manufacturing CF 3 C 2 Commercial (Yonezawa) Capacity : 30 tons / year Purity: > 99%,RSS: < 0.5% In accordance with cgmp Di-peptide Derivative (Japan) Manufacturing Commercial (Yonezawa) Capacity : 1.5 tons / year In accordance with cgmp Di-peptide Derivative (Japan) Manufacturing Commercial (Yonezawa) Capacity : 500kg / year In accordance with cgmp

15 Expertise Commercial exa-peptide 150 kg / year (25 kg/ lot) is, Trp, Ser, etc Tri-peptide 30 kg / year (15 kg/ lot) Arg, etc Clinical Tri-peptide Penta-peptide Deca-peptide Peptide mimic 1 Project 30 kg (2008) 4 Projects 10, 15, 20 kg (2008) 1 Project 50 g (2008) 2 Projects 10 kg (2006) 2,8 kg (2007)

16 Expertise L-R Cl X 2 X Ac-D-2-al-D-4-ClPhe-D-3-Pal Registry umber: IV / CV 2 X-L-Arg(nitro)-Pro-D-Ala-2 Y 2 X:Cbz-,BC-,Fmoc- X:Cbz-, BC-, Fmoc- Y:Cbz-, BC-, Fmoc- X-Lys(Ipropyl.Y)-Pro-D-Ala-2 R 1 R 1 chiral 3-amino-2-hydroxyalkanoic acid derivatives (norstatine analogues) 2 R 2 2

17 Timeline of ID Actual Example ID Project (total steps: 5) GLP-API 2 Lot, GMP-API 1 Lot Customer GMP audits Kg-Lab 1kg Analytical study 20g 3 GLP-API 1st 20Kg GLP-API 2nd 20Kg GMP-API 20Kg months 1 Technical feasibility study, Raw material availability and Price idea Process development and Firm quotation for pilot quantities Kg-Lab production Small samples for determining specification GLP Production and Reports Process optimization and Establishing specification Analytical development Analytical method Validation GMP Production and Reports

18 What can we do? Process Development = solid phase to solution phase Pilot production Mass Production and Stable Supply = scale-up study, supply chain, PQ/PV Process Validation (CMC) = method validation, impurity study, stability study

19 Summary amari has experience and technologies of Custom Manufacturing. amari can work together with you to solve your short-term term and long-term needs.