1. AMBIOPHARM, Inc. Peptide API Manufacturing and Services

2. AmbioPharm History AmbioPharm, registered in California, USA in 2005
AmbioPharm, acquired UCB Bioproducts at North Augusta, SC in 2007
Shanghai AmbioPharm, started at Shanghai, China in 2007
Chemspec and AmbioPharm Joint Venture Facility, Shanghai, China in 2014
AmbioPharm USA
Shanghai AmbioPharm
Chemspec AmbioPharm

3. 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 Hainan site: 3 “483” observations
August 2013, FDA PAI of Shanghai site: 2 “483” observations
August 2014, FDA approved Shanghai AmbioPharm (EIR Letter)
October 2014, FDA PAI of US site: 1 ‘483’ observation
November 2014, FDA approved AmbioPharm US site (FDA Letter)

4. Seasoned Management Team
Chris Bai, Ph.D. President & CEO 
18 years in pharmaceutical manufacturing experience.
Former president and CEO of American Peptide Company
Jim Hampton, BS, MS, Exec VP of BD and Sales 
18 years in pharmaceutical business development
Ruoping Zhang, BS, VP of Manufacturing
14 years in peptide API manufacturing experience.
Robert Geiger, Ph.D. MBA. VP of Quality
14 years in pharmaceutical QA/QC, business development
Simrat Singh, Ph.D., Director of Analytical & QC
8 years in Pharmaceutical product development
Stephen Kiel, MBA, CPA, Chief Financial Officer
35 years experience in financial management

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. 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
Hainan, China
Generics Synthesis
Generics Downstream
Generics Final product

7. AmbioPharm, N. Augusta, SC USA
32 acres acquired from UCB Pharma in 2006
Existing cGMP/Process Development facility on 2 acres

8. Expansion of North Augusta Manufacturing Facility
60cm HPLC Column 400L Lyophilizer
Warehouse

9. Purification Capacity by 2015 28 kg/batch and 300 kg/year

10. Non-Sterile Peptide API Manufacturing
Purification Scale from 1 gram up to
30 kg/batch Final Peptide
Preparative HPLC columns:
ID: 5, 8, 15, 20 and 30cm (up to 7kg/batch)
ID: 45cm (up to 15 kg/batch)
ID: 60cm (up to 28 kg/batch)

11. Non-Sterile Peptide API Manufacturing
Freeze Drying Capacity
Four (4) Manifold lyophilizers (up to 1kg/batch)
100L tray lyophilizer to be installed by Q (up to 7 kg/batch)
200L tray lyophilizer (up to 15 kg/batch)
400L tray lyophilizer (up to 30 kg/batch)

12. Phase II Expansion- Q3 2015 Tank Farm for Additional Solvent Capacity
Annex to House 60cm Column Water System & Future Expansion Area

13. AmbioPharm Facilities - Shanghai Campus

14. Process Development, cGMP Pilot, and Large-Scale API Manufacturing Facilities

15. Manufacturing Expansion of 30,000 ft2 Completed at Shanghai Facility
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. 2015 Synthesis Manufacturing Capacity 200 kg crude/batch & 2,000 kg crude/year
30 solid phase reactors
1L, 5L, 10L, 30L, 50L, 80L, 200L
(up to 20kg crude/batch)
20 solution phase reactors
10L, 20L, 30L, 50L, 80L, 200L
(up to 40kg crude/batch)
New 1,000L Solid Phase Reactor
(up to 100kg crude/batch
New 5,000L Solution Phase Reactor
(up to 200kg crude/batch) 18

19. Final Product Release Quality Control Laboratory HPLC (12) GC (2)
LC/MS (2) IC
SEC
Amino acid analysis
UPLC KF
Endotoxin and Bioburden

20. 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 reduces the manufacturing cost further on larger scales

21. Manufacturing Cost Comparison

22. 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 APIs