Presentation Of Qiming Biotech August 2012

  • 256 views
Uploaded on

General description of Qiming Bio-Tech, plants, development, chemistry

General description of Qiming Bio-Tech, plants, development, chemistry

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
256
On Slideshare
0
From Embeds
0
Number of Embeds
1

Actions

Shares
Downloads
9
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. Zhejiang Qiming Biotech Co., Ltd. Generic API Manufacturer G i API M f t Custom Process Development Contract Manufacturing
  • 2. History• Qiming Biotech was formed in 2010 from the merger of Eastbound Synopharma and the API division of Qiming Pharma• Eastbound was a company established in 2002 in Shanghai and well known for custom process development of key pharmaceutical intermediates• Qiming Pharma is a long term manufacturer of both APIs and intermediates for the pharmaceutical industry with di t di t f th h ti l i d t ith more than 17 years of experience.
  • 3. Organizations Qiming Biotech Eastbound Synopharma Qiming Pharma (HK) Holdings Ltd Financial Non‐cGMP Manufacturing Shangyu Process Process  Shangyu Development  Manufacturing Institute cGMP Manufacturing g Process Development p Quality Assurance Technology Transfer
  • 4. Management TeamManagement Team Dr. Leo Lin VP Quality and  Regulatory Affairs Chris Vance Michael Zhang VP Sales, Marketing and  President & CEO Business Development Dr. Yuan Li VP Process Development  VP Process Development Operations Dr. Young Lo Research Fellow R h F ll Linzhong Zhou            Over 100 years of Western  Over 100 years of Western Finance Director Finance Director Pharmaceutical Business Experience
  • 5. Our Advantages• cGMP and non‐cGMP manufacturing of APIs and  GMP d GMP f t i f API d intermediates for pharmaceutical and veterinary industry• Sophisticated development and manufacturing capability  p p g p y offers custom solutions to complex problems• Frequent communication with clients; no surprises • Broad technology platform with niche capabilities on  commercial scale • Experienced team of managers with western Experienced team of managers with western  pharmaceutical experience 
  • 6. Business FocusB i F cGMP and Non‐GMP Manufacturing APIs and IntermediatesCustom Solutions to Complex Problems
  • 7. Qiming Biotech Manufacturing Qiming Biotech Manufacturing• Shangyu site is 43,000 m2 (10+ acres) located in  Hangzhouwan Industrial Industrial  Park in Shangyu, Zhejiang • Plant 1 certified by China’s  SFDA for APIs and inspected  by major pharma by major pharma companies • Plant 2 installation  underway.  Designed for ICH  Q7A level cGMP compliance
  • 8. APIs ListAPIs ListNo. API CAS # Pharmaceutical Status US DMF filed. Inspected by US customer and waiting  non‐steroidal anti‐inflammatory  for FDA inspection at 2Q 2012. ANDA approval is driving FDA 1 Mefenamic acid 61‐68‐7 61 68 7 drug (NSAID).   drug (NSAID) schedule.  Commercial production presently for non‐ Tradename:  PONSTEL regulatory market Anitinflammatory,  mucoregulator.  No SFDA file, but in commercial production for non‐2 Talniflumate 66898‐62‐2 Tradename TALMAIN (Korea),  regulatory market LOMUCIN non‐steroidal anti‐inflammatory  drug (NSAID).  Tradename:   No SFDA file, but in commercial production for non‐3 Tolfenamic acid 13710‐19‐5 CLOTAM regulatory market Calcium 4 51828 93 4 51828‐93‐4 Phenylpyruvate5 α‐Ketovaline Calcium 51828‐94‐5 Combination of amino acids for 6 α‐Ketoleucine Calcium 51828‐95‐6 use in managing protein  Product licenses approved by SFDA. Final documentation  D,L‐α‐Ketoisoleucine  metabolism during renal  underway. SFDA inspection expected in 3Q 2012 with 7 66872‐75‐1 Calcium insufficiency.  Tradename:  approval thereafter.  y y 2‐Hydroxy‐4‐ Ketosteril8 (methylthio)butyric  4857‐44‐7 acid calcium salt Antihistamine, In commercial production for non‐regulatory market.9 Fexofenadine HCl 15439‐40‐8 Tradename:  Allegra US DMF will be filed in Q3, 2012 Antidepressant10 Venlafaxine 93413‐69‐5 In commercial production for non‐regulatory market. Tradename:  Effexor Tradename: Effexor Stroke recovery Process development completed, documents will be filed 11 Edaravone 89‐25‐8 Traded by Mitsubishi with SFDA in Q4 2012 Respiratory stimulant.   Process development completed and US DMF will be filed 12 Doxapram 7081‐53‐0 Tradename:  Dopram with FDA in Q4 2012
  • 9. Q Qiming Biotech Manufacturing g otec a u actu g• cGMP Production in two multi‐purpose manufacturing units.   – I l t d Isolated areas for finishing final API steps including drying, milling, blending f fi i hi fi l API t i l di d i illi bl di – Wide range of vessels, glass and SS, to permit flexible process arrangements – Solid procedures and training programs to assure cGMP quality adherence• Experienced QC and QA team to review and audit manufacturing  Experienced QC and QA team to review and audit manufacturing procedures – On site analytical laboratories assure timely data for manufacturing and validated  procedures for regulatory filing.• Western pharma audited facilities – Major pharma inspections – PAI inspection by US FDA completed.  Facility approved with no 483• Non‐GMP Production partnerships with Qiming Pharma and Dafeng Eastbound – Large scale facilities permit easy scale‐up and supply of critical intermediates – Wide range of chemistry practiced••
  • 10. Key TechnologiesKey Technologies• Oxidation with various oxidants O id ti ith i id t• Halogenation including Br, I and Cl• Heterocyclic chemistry: indoles, pyridines, piperidines, etc. Heterocyclic chemistry: indoles pyridines piperidines etc• Grignard reactions• Sandmeyer Reactions y• Nitration using nitric acid• Hydride reactions• Other chemical reactions such as acylation, esterification,  condensation, cyclization, sulfonation, polymerization etc.
  • 11. Plant 1:  cGMPPlant 1: cGMP Plant• B ilt i 2005 t Built in 2005 to produce API and  d API d late stage intermediates• Certified by SFDA in 2006• Five additional APIs developed for Five additional APIs developed for  SFDA and western regulatory  approval Vessels 11.0 m3 Glass lined Stainless• US DMF submitted for mefenamic US DMF submitted for mefenamic 2000 liter 2000 lit 2 2 acid; awaiting FDA inspection and  500 liter 4 2 certification Centrifuge flatbed 2 stainless Dryer Tray dryer 1 500 liter Double cone vacuum 1 1000 liter Double cone vacuum 1 Purified Water System Mill HVAC class 100,000 rated FDA rating: D 15 Pa ±1°C, ±10% RH
  • 12. Vessels 16.6 m3 Glass lined Stainless 3000 liter 1 Plant 2: cGMP Plant 2000 liter 1000 liter 500 liter 1 3 3 1 1 1 300 liter 3 200 liter 1 100 liter 1 Centrifuge 2 Halar coated 2 Stainless Dryer Tray dryer d 42nd Floor Double cone vacu 1 GMP section 500 liter Glass lined Filter dryer Mill Blender 200 liter HVAC class 100,000 rated FDA rating: D 15 Pa ±1°C, ±10% RH1st Floor Controlled access and HVAC
  • 13. Vessels 16.6 m3 Glass lined Stainless 3000 liter 1 Plant 2: cGMP Plant 2000 liter 1000 liter 500 liter 1 3 3 1 1 1 300 liter 3 200 liter 1 100 liter 1 Centrifuge 2 Halar coated 2 Stainless Dryer Tray dryer d 42nd Floor Double cone vacu 1 GMP section 500 liter Glass lined Filter dryer Mill Blender 200 liter HVAC class 100,000 rated FDA rating: D 15 Pa ±1°C, ±10% RH1st Floor
  • 14. Vessels 16.6 m3 Glass lined Stainless 3000 liter 1 Plant 2: cGMP Plant 2000 liter 1000 liter 500 liter 1 3 3 1 1 1 300 liter 3 200 liter 1 100 liter 1 Centrifuge 2 Halar coated 2 Stainless Dryer Tray dryer d 42nd Floor Double cone vacu 1 GMP section 500 liter Glass lined Filter dryer Mill Blender 200 liter HVAC class 100,000 rated FDA rating: D 15 Pa ±1°C, ±10% RH1st Floor
  • 15. Facilities and UtilitiesFacilities and Utilities• Total area:  43,000 m2• Total reactor volume: Plant 1:  11 m3 Plant 2:  17 m3• Reactors: Glass, Stainless Glass Stainless• Total employees: 70• Reaction Temperature Range:   ‐30 to 150 °CUtilities:• Po er Power: Total capacity 800 kw Total capacit 800 k• Steam: 10 bar max• Refrigeration: g 120,000 kCal ,
  • 16. Shangyu Process Development Institute• More than 300 projects completed in the past 7 years;• Over 15% of developed projects moved into pilot or  p p j p commercial scale;• Professional R&D team with western pharma working  experience;• Long term business relationship with big pharmas and  western CMO companies. 
  • 17. Shangyu Process Development Institute Process Development Institute
  • 18. Shangyu PSh Process Development Institute D l t I tit tProcess Development, Analytical Method  p , y Development and Production Support• 20 Chemists & Engineers including Dr  Young Lo and Dr Yuan Li• 1400 m2 modern development and  analytical laboratory• 24 fume hoods for bench development• 3 walk‐in hoods for cGMP kilo lab• State of the art analytical capability – HPLC, GC, UV, FT‐IR, etc – Easy access to AA, LC‐MS, TGA, DSC,  NMR, EA, X‐ray, etc• Onsite access to chemical research Onsite access to chemical research  resources – SciFinder, Reaxys
  • 19. Development Laboratory& Kilo LabDevelopment LaboratoryBench LabsBench Labs 7 350 m2 350 m Fume hoods 24 Each lab air controlled independentlyKilo Lab Vessels Glass 50‐200 liters Capacity 1‐5 kg p y g cGMP finishing section tray dryer filter press HVAC class 100,000 Kilo labAnalytical LabAnalytical Lab 7 700 m2 700 m HPLC GC IR Microbiology Stability y
  • 20. Development Laboratory& Kilo LabDevelopment LaboratoryBench LabsBench Labs 7 350 m2 350 m Fume hoods 24 Each lab air controlled independentlyKilo Lab Vessels Glass 50‐200 liters Capacity 1‐5 kg p y g cGMP finishing section tray dryer filter press HVAC class 100,000Analytical LabAnalytical Lab 7 700 m2 700 m HPLC GC IR Microbiology Stability y
  • 21. No SurprisesN S i Reply to inquiry Project evaluation within 3 days Detailed proposal  Project preparation presented within 10 days Frequent progress reports;  Project execution j no surprises no surprises Project completion Campaign reports and  Campaign reports and analytical documentation
  • 22. Thank You Visit us in  Shangyu, ZhejiangDr. Yuan Li Chris VanceVP Process Development Operations VP Sales, Marketing Business Dev Sales Marketing,yuan.li@qimingbiotech.com chris.vance@eastboundpharma.com+86 (575) 8272 6990-8011 +1 (804) 601-2760