1. AMBIOPHARM, Inc. Supplier of Peptide API Manufacturing and Services

2. 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 facility- Chemspec AmbioPharm, Shanghai, China

3. AmbioPharm Overview One of Leading Peptide Manufacturers in the World
AmbioPharm, registered in California, USA
Manufacturer of generic peptide APIs
Contract manufacturing peptide APIs for pharma and biotech worldwide
The company is one of leading major peptide manufacturers in the world
2 commercial generic peptide APIs and 18 generic peptide APIs in the development pipelines
>100 NCE peptide CMO projects.

4. 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

5. Chief Executive Officer
Chris Bai
Chief Executive Officer
Jim Hampton
Exec VP of Bus Dev
Robert Geiger
VP of Quality
HR & Administration
Ruoping Zhang
VP of Manufacturing
Proc Dev
Production
Director of Sales
Quality Control
QA and Regulatory
Analytical Dev
Downstream
US, EU, Canada, Asia
Sales reps
Facilities
Synthesis
Chemist
QA Manager
Microbiologist
Chemist
Chemist
Technician
Chemist

6. 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

7. 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

8. AmbioPharm Manufacturing Sites
Non-Sterile API Peptide Manufacturing
AmbioPharm, Inc.- World HQ in North Augusta, SC USA
Shanghai , China
NCEs Synthesis
Analytical Dev
R&D
North Augusta, SC
NCEs downstream mfg
QC testing
QA release

9. API Manufacturing Facility at North Augusta Building No. 200 and 300
60cm HPLC Column 400L Lyophilizer
Warehouse

10. Current API Purification Capacity 400 kg/year within Building No. 200

11. 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)

12. 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)

13. AmbioPharm Expanding its Headquarter at North Augusta, South Carolina, USA

14. 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

15. API Synthesis and Purification Facility at Shanghai Building No
API Synthesis and Purification Facility at Shanghai Building No. 13, Commercial Manufacturing
Dedicated manufacturing line offers further cost savings at larger scale.

16. 1st to 3rd Floor of Building No
1st to 3rd Floor of Building No L Solid Phase Reactors 5000L Solution Phase Reactors

17. 5th Floor of Building No. 13 4 Purification Suites 20cm, 30cm, 45cm HPLC Purification Columns

18. 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) 18 18

19. AmbioPharm Designing and Building a New Chinese Facility at Shanghai to be completed by 2018

20. Increase Peptide API Manufacturing Capacity to 400kg/year by 2016

21. 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

22. 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

23. 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

24. 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

25. Manufacturing Cost Comparison

26. AmbioPharm, Inc.
Largest peptide manufacturing capacity; actively expanding capacity to meet specific customer needs
> 100 years management experience in cGMP
The highest technical capabilities in the peptide industry
Three manufacturing facilities to serve customers worldwide
Setting a new standard for the quality of generic APIs