presentation of qiming biotech august 2012
DESCRIPTION
General description of Qiming Bio-Tech, plants, development, chemistryTRANSCRIPT
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Zhejiang Qiming Biotech Co., Ltd.
G i API M f tGeneric API Manufacturer
Custom Process Development
Contract Manufacturing
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History
Qiming Biotech was formed in 2010 from the merger of • 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 intermediatesdevelopment of key pharmaceutical intermediates
• Qiming Pharma is a long term manufacturer of both APIs d i t di t f th h ti l i d t ith and intermediates for the pharmaceutical industry with
more than 17 years of experience.
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OrganizationsOrganizations
Qiming Biotech
Eastbound Synopharma(HK) Holdings Ltd
Qiming Pharma
Financial Non‐cGMP Manufacturing
Shangyu ProcessShangyu
Manufacturing
Shangyu Process Development
InstitutecGMP Manufacturing Process Developmentg p
Quality AssuranceTechnology Transfer
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Management TeamManagement TeamDr. Leo Lin
VP Quality and
Michael ZhangChris Vance
VP Sales, Marketing and
Regulatory Affairs
President & CEO
Dr. Yuan Li
VP Process Development
Business Development
VP Process Development Operations
Dr. Young Lo
R h F llResearch Fellow
Linzhong Zhou
Finance DirectorOver 100 years of Western Finance DirectorOver 100 years of Western Pharmaceutical Business Experience
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Our Advantages
GMP d GMP f t i f API d• cGMP and non‐cGMP manufacturing of APIs and intermediates for pharmaceutical and veterinary industry
• Sophisticated development and manufacturing capability p p g p yoffers 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
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B i FBusiness Focus
cGMP and Non‐GMP ManufacturingAPIs and Intermediates
Custom Solutions to Complex Problems
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Qiming Biotech ManufacturingQiming Biotech Manufacturing
• Shangyu site is 43,000 m2
(10+ acres) located in Hangzhouwan IndustrialHangzhouwan Industrial Park in Shangyu, Zhejiang
• Plant 1 certified by China’s SFDA for APIs and inspected by major pharma companiesby major pharma companies
• Plant 2 installation underway. Designed for ICH Q7A level cGMP compliance
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APIs ListAPIs ListNo. API CAS # Pharmaceutical Status
1 Mefenamic acid 61 68 7non‐steroidal anti‐inflammatory drug (NSAID)
US DMF filed. Inspected by US customer and waiting for FDA inspection at 2Q 2012. ANDA approval is driving FDA
1 Mefenamic acid 61‐68‐7 drug (NSAID). Tradename: PONSTEL
schedule. Commercial production presently for non‐regulatory market
2 Talniflumate 66898‐62‐2
Anitinflammatory, mucoregulator. Tradename TALMAIN (Korea), LOMUCIN
No SFDA file, but in commercial production for non‐regulatory market
LOMUCIN
3 Tolfenamic acid 13710‐19‐5
non‐steroidal anti‐inflammatory drug (NSAID). Tradename: CLOTAM
No SFDA file, but in commercial production for non‐regulatory market
4Calcium
51828‐93‐44Phenylpyruvate
51828 93 4
Combination of amino acids for use in managing protein metabolism during renal insufficiency. Tradename: Ketosteril
Product licenses approved by SFDA. Final documentation underway. SFDA inspection expected in 3Q 2012 with approval thereafter.
5 α‐Ketovaline Calcium 51828‐94‐56 α‐Ketoleucine Calcium 51828‐95‐6
7D,L‐α‐Ketoisoleucine Calcium
66872‐75‐1
2‐Hydroxy‐4‐8
y y(methylthio)butyric acid calcium salt
4857‐44‐7
9 Fexofenadine HCl 15439‐40‐8Antihistamine,Tradename: Allegra
In commercial production for non‐regulatory market.US DMF will be filed in Q3, 2012
10 Venlafaxine 93413‐69‐5AntidepressantTradename: Effexor
In commercial production for non‐regulatory market.Tradename: Effexor
11 Edaravone 89‐25‐8Stroke recoveryTraded by Mitsubishi
Process development completed, documents will be filed with SFDA in Q4 2012
12 Doxapram 7081‐53‐0Respiratory stimulant. Tradename: Dopram
Process development completed and US DMF will be filed with FDA in Q4 2012
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Qiming Biotech Manufacturing
• cGMP Production in two multi‐purpose manufacturing units. I l t d f fi i hi fi l API t i l di d i illi bl di
Q g otec a u actu g
– Isolated areas for finishing final API steps including drying, milling, blending
– 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 DafengEastbound
– Large scale facilities permit easy scale‐up and supply of critical intermediates
– Wide range of chemistry practiced
••
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Key TechnologiesKey Technologies
O id ti ith i id t• Oxidation with various oxidants
• Halogenation including Br, I and Cl
• Heterocyclic chemistry: indoles pyridines piperidines etc• Heterocyclic chemistry: indoles, pyridines, piperidines, etc.
• Grignard reactions
• Sandmeyer Reactionsy
• Nitration using nitric acid
• Hydride reactions
• Other chemical reactions such as acylation, esterification, condensation, cyclization, sulfonation, polymerization etc.
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Plant 1: cGMP PlantPlant 1: cGMP Plant
B ilt i 2005 t d API d• Built in 2005 to produce API and late stage intermediates
• Certified by SFDA in 2006• Five additional APIs developed for• Five additional APIs developed for
SFDA and western regulatory approval
• US DMF submitted for mefenamic Vessels 11.0 m3 Glass lined Stainless2000 lit 2 2US DMF submitted for mefenamic
acid; awaiting FDA inspection and certification
2000 liter 2 2500 liter 4 2
Centrifuge flatbed 2 stainlessDryer Tray dryer 1
500 liter Double cone vacuum 11000 liter Double cone vacuum 1Purified Water SystemMillHVAC class 100,000 rated
FDA rating: D15 Pa±1°C, ±10% RH
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Vessels 16.6 m3Glass lined Stainless
3000 liter 12000 liter 1 11000 liter 3 1Plant 2: cGMP Plant 1000 liter 3 1500 liter 3 1300 liter 3200 liter 1100 liter 1
Centrifuge 2 Halar coated 2 Stainlessd
Plant 2: cGMP Plant
Dryer Tray dryer 4Double cone vacu 1
GMP section500 liter Glass linedFilter dryerMill2n
dFl
oor
Blender 200 literHVAC class 100,000 rated
FDA rating: D15 Pa±1°C, ±10% RH
1stFl
oor
Controlled access and HVAC
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Vessels 16.6 m3Glass lined Stainless
3000 liter 12000 liter 1 11000 liter 3 1Plant 2: cGMP Plant 1000 liter 3 1500 liter 3 1300 liter 3200 liter 1100 liter 1
Centrifuge 2 Halar coated 2 Stainlessd
Plant 2: cGMP Plant
Dryer Tray dryer 4Double cone vacu 1
GMP section500 liter Glass linedFilter dryerMill2n
dFl
oor
Blender 200 literHVAC class 100,000 rated
FDA rating: D15 Pa±1°C, ±10% RH
1stFl
oor
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Vessels 16.6 m3Glass lined Stainless
3000 liter 12000 liter 1 11000 liter 3 1Plant 2: cGMP Plant 1000 liter 3 1500 liter 3 1300 liter 3200 liter 1100 liter 1
Centrifuge 2 Halar coated 2 Stainlessd
Plant 2: cGMP Plant
Dryer Tray dryer 4Double cone vacu 1
GMP section500 liter Glass linedFilter dryerMill2n
dFl
oor
Blender 200 literHVAC class 100,000 rated
FDA rating: D15 Pa±1°C, ±10% RH
1stFl
oor
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Facilities and UtilitiesFacilities and Utilities
• Total area: 43,000 m2
• Total reactor volume: Plant 1: 11 m3
Plant 2: 17 m3
• Reactors: Glass Stainless• Reactors: Glass, Stainless• Total employees: 70• Reaction Temperature Range: ‐30 to 150 °C
Utilities:• Po er Total capacit 800 k• Power: Total capacity 800 kw• Steam: 10 bar max• Refrigeration: 120,000 kCalg ,
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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;experience;• Long term business relationship with big pharmas and
western CMO companies.
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Shangyu Process Development InstituteShangyu Process Development Institute
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Sh P D l t I tit tShangyu Process Development Institute
Process Development, Analytical Method p , yDevelopment 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 researchOnsite access to chemical research resources
– SciFinder, Reaxys
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Development Laboratory & Kilo LabDevelopment Laboratory
Bench Labs 7 350 m2Bench Labs 7 350 mFume hoods 24Each lab air controlled independently
Kilo LabVessels Glass 50‐200 litersCapacity 1‐5 kgp y g
cGMP finishing sectiontray dryerfilter press
HVAC class 100,000
Analytical Lab 7 700 m2Kilo lab
Analytical Lab 7 700 mHPLCGCIRMicrobiologyStabilityy
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Development Laboratory & Kilo LabDevelopment Laboratory
Bench Labs 7 350 m2Bench Labs 7 350 mFume hoods 24Each lab air controlled independently
Kilo LabVessels Glass 50‐200 litersCapacity 1‐5 kgp y g
cGMP finishing sectiontray dryerfilter press
HVAC class 100,000
Analytical Lab 7 700 m2Analytical Lab 7 700 mHPLCGCIRMicrobiologyStabilityy
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N S iNo Surprises
Project evaluationReply to inquiry within 3 days
Project preparationDetailed proposal
presented within 10 days
Project executionFrequent progress reports;
no surprisesj no surprises
Campaign reports andProject completion Campaign reports and analytical documentation
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Thank YouVisit us in
Shangyu, Zhejiang
Chris VanceVP Sales Marketing Business Dev
Dr. Yuan LiVP Process Development Operations VP Sales, Marketing, Business Dev
[email protected]+1 (804) 601-2760
VP Process Development [email protected]+86 (575) 8272 6990-8011