Transcript PowerPoint - AmbioPharm, Inc.

AMBIOPHARM, Inc.
Supplier of Peptide API
Manufacturing and Services
Ambio Locations and History
Chemspec AmbioPharm
AmbioPharm USA
Shanghai AmbioPharm
2005
• AmbioPharm, registered in California, USA
2007
• AmbioPharm, acquired UCB Bioproducts at North Augusta, SC
• Shanghai AmbioPharm, started at Shanghai, China
2012
• Ambio formed for developing complex generic drugs
2015
• Shanghai AmbioPharm built a new commercial manufacturing facilityChemspec AmbioPharm, Shanghai, China
AmbioPharm Overview
One of Leading Peptide Manufacturers in the World
• AmbioPharm, registered in California, USA
o Manufacturer of generic peptide APIs
o Contract manufacturing peptide APIs for pharma and biotech worldwide
• The company is one of leading major peptide manufacturers in the world
o 2 commercial generic peptide APIs and 18 generic peptide APIs in the development
pipelines
o >100 NCE peptide CMO projects.
Generic Peptide APIs
Generic Peptide API Manufacturer
Generic Peptide Portfolio
API’s Available Today:
•Bivalirudin (DMF, FDA approved)
•Eptifibatide (DMF, FDA approved)
•Glucagon (DMF)
•Leuprolide (DMF)
•Octreotide (DMF)
•Glatiramer (DMF)
•Teriparatide
•Nesiritide
•Exenatide
•Carbetocin
•Liraglutide (DMF)
•Corticotropin
•Teduglutide
•Lanreotide
In Development:
• Pramlintide
• Ganirelix
• Cosyntropin
• Triptorelin
• Goserelin
• Linaclotide
• Vasopressin
Chris Bai
Chief Executive Officer
Robert Geiger
VP of Quality
HR & Administration
Ruoping Zhang
VP of Manufacturing
Proc Dev
QA and Regulatory
Quality Control
Chemist
Microbiologist
Production
Director of Sales
Analytical Dev
Facilities
QA Manager
Jim Hampton
Exec VP of Bus Dev
Chemist
Technician
Synthesis
Chemist
Downstream
Chemist
US, EU, Canada, Asia
Sales reps
Seasoned Management Team
Name
Role
Experience
Chris Bai, PhD
President & CEO
20 years in pharmaceutical manufacturing
Jim Hampton, BS
Exec VP of BD and Sales
20 years in pharmaceutical business development
Ruoping Zhang, BS
VP Manufacturing
18 years in peptide API manufacturing
Stephen Kiel, MBA, CPA
CFO
35 years in financial management
Robert Geiger, PhD
VP Quality
15 years in pharmaceutical quality management
Simrat Singh, PhD
Sr. Director Operations
10 years in pharmaceutical product development
Isabel Tan
Sr. Director of Quality
10 years in pharmaceutical quality management
Guoging Zhang
Sr. Director of Mfg & Process
10 years in peptide API manufacturing
Sherry Li
Sr. Director of Analytical & QC
10 years in pharmaceutical quality control
Compliance & Inspection History
– November 2008, FDA audit of USA site: no 483 observations
– August 2011, FDA audit of USA site: no 483 observations
– October 2011, sFDA audit of Shanghai site: no observations
– March 2013, FDA PAI of USA site: 4 “483” observations
– August 2013, FDA PAI of Shanghai site: 2 “483” observations
– October 2014, FDA PAI of US site: 1 ‘483’ observation
– January 2016, FDA audit of Shanghai site: no “483” observations
AmbioPharm Manufacturing Sites
API Manufacturing Facility at North Augusta
Building No. 200 and 300
Warehouse
60cm HPLC Column
400L Lyophilizer
Current API Purification Capacity 400 kg/year within
Building No. 200
Non-Sterile Peptide API Manufacturing
Purification Scale From 1g to 30
kg/batch Final Peptide
 Preparative HPLC columns,
 ID: 5, 8, 15, 20 and 30cm
(up to 7kg/batch)
 ID: 45cm HPLC Column
(up to 15 kg/batch)
 ID: 60cm HPLC Column
(up to 28 kg/batch)
Non-Sterile Peptide API Manufacturing
Freeze Drying Capacity
 Four (4) Manifold lyophilizers
(up to 1 kg/batch)
 100L tray lyophilizer
(up to 7 kg/batch)
 200L tray lyophilizer
(up to 15 kg/batch)
 400L tray lyophilizer
(up to 30 kg/batch)
AmbioPharm Expanding its Headquarter at
North Augusta, South Carolina, USA
API Synthesis Facility at Shanghai Building No.1
20 kg/batch & 300 kg/year Crude Peptide
Process Development, cGMP Pilot, and
Large-Scale API Manufacturing Facilities
API Synthesis and Purification Facility at Shanghai
Building No. 13, Commercial Manufacturing
1st to 3rd Floor of Building No. 13
1000L Solid Phase Reactors
5000L Solution Phase Reactors
5th Floor of Building No. 13
4 Purification Suites
20cm, 30cm, 45cm HPLC Purification Columns
Synthesis Manufacturing Capacity
200 kg crude/batch & 2000 kg crude/year
 30 solid phase reactors
1L, 5L, 10L, 30L, 50L, 80L, 200L
(up to 20 kg crude/batch)
 20 solution phase reactors
10L, 20L, 30L, 50L, 80L, 200L
(up to 40kg crude/batch)
 1000L Solid Phase Reactor
(up to 100 kg crude/batch)
 5000L Solution Phase Reactor
(up to 200 kg crude/batch)
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AmbioPharm Designing and Building a New Chinese
Facility at Shanghai to be completed by 2018
Increase Peptide API Manufacturing Capacity
to 400kg/year by 2016
PVB Batches
SCALE= 7 KG
Shanghai, China
Future Additional
Manufacturing Line
SCALE= 28 KG
Shanghai, China
CRUDE SYNTHESIS
CRUDE SYNTHESIS
(Peptide Resin)
(Peptide Resin)
North Augusta, South Carolina
North Augusta, South Carolina
INTERMEDIATE PURIFICATION
INTERMEDIATE PURIFICATION
(Crude Peptide)
(Crude Peptide)
FINAL PURIFICATION & DRYING
TO API POWDER
FINAL PURIFICATION & DRYING
TO API POWDER
(Final Product)
(Final Product)
QA RELEASE
QA RELEASE
(Crude Peptide)
(Crude Peptide)
Final Product Released in USA
Quality Control Laboratory
 HPLC (12)
 GC (2)
 LC/MS (2)
 IC
 SEC
 Amino acid analysis
 UPLC
 KF
 Endotoxin and Bioburden
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Process Development Center at North
Augusta and Shanghai
The Process development group works to
achieve the following goals:
– Efficacy and selectivity (reach the requirements
in terms of quality)
– Scalability (transferable into large to very large scale)
– Productivity (good yield and recovery of the target)
– Reproducibility (repeated campaigns must produce
the API with the same profile)
– Robustness
– Safe with regard to people and environment
Analytical Development Group at North
Augusta and Shanghai
In parallel with the process development,
analytical development provides tools
that are able to:
–
–
–
–
Monitor the process for side reactions
Monitor the process to reach required purity
Monitor the process to limit the residual impurities
Control the final API and ensure the required
quality attributes
– Provides “cushion” of impurities to allow
formulators more breathing room
AmbioPharm’s Advantage
– Low Cost of Manufacturing
• Close to all the major raw material manufacturing
companies (amino acid derivatives and solvents)
• Low cost to manufacture under fully controlled cGMP
quality system and experienced management team
• Low cost on solvents
DMF, a major cost for peptide synthesis on large scale
US Competitor’s cost: $3,500/ton
AmbioPharm’s cost:
$1,450/ton
• The solvent recovery system would reduce the
manufacturing cost further on larger scales
Manufacturing Cost Comparison
Cost Comparison
$12,000,000
$10,000,000
$8,000,000
US Competitor (Cost US$)
$6,000,000
AmbioPharm (Cost US$)
$4,000,000
$2,000,000
$0
50 g
200 g
500 g
1000 g
2000 g
Manufacturing Scale
5000 g
10,000 g
AmbioPharm, Inc.
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> 100 years management experience in cGMP
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The highest technical capabilities in the peptide industry
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Largest peptide manufacturing capacity; actively
expanding capacity to meet specific customer needs
Three manufacturing facilities to serve customers
worldwide
Setting a new standard for the quality of generic APIs