AMBIOPHARM, Inc.

Peptide API Manufacturing and Services

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

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)

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

 

  Chris BaiChief Executive Officer

      Jim HamptonExec VP of Bus Dev

Ruoping ZhangVP of Manufacturing

HR & Administration

Production

  

Robert GeigerVP of Quality

Quality ControlQA and Regulatory

 US, EU, Canada, Asia

Sales reps

  Proc Dev  Director of Sales

 

 Analytical Dev

Facilities  Synthesis  Downstream

 Chemist  Microbiologist Chemist Chemist Technician

 Chemist QA Manager

AmbioPharm Manufacturing Sites

Non-Sterile API Peptide ManufacturingAmbioPharm, 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

AmbioPharm, N. Augusta, SC USA

• 32 acres acquired from UCB Pharma in 2006• Existing cGMP/Process Development facility on 2 acres

Expansion of North Augusta Manufacturing Facility

60cm HPLC Column 400L Lyophilizer

Warehouse

Purification Capacity by 201528 kg/batch and 300 kg/year

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)

Non-Sterile Peptide API Manufacturing

Freeze Drying Capacity Four (4) Manifold lyophilizers (up to

1kg/batch)

100L tray lyophilizer to be installed by Q4 2014 (up to 7 kg/batch)

200L tray lyophilizer (up to 15 kg/batch)

400L tray lyophilizer (up to 30 kg/batch)

Phase II Expansion- Q3 2015

Tank Farm for Additional Solvent Capacity

Annex to House 60cm Column Water System & Future Expansion Area

AmbioPharm Facilities - Shanghai Campus

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

Manufacturing Expansion of 30,000 ft2 Completed at Shanghai Facility

Dedicated manufacturing line offers

further cost savings at larger scale.

1st to 3rd Floor of Building No. 131000L Solid Phase Reactors5000L Solution Phase Reactors

5th Floor of Building No. 134 Purification Suites20cm, 30cm, 45cm HPLC Purification Columns

2015 Synthesis Manufacturing Capacity200 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)

Final Product Release

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

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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

Manufacturing Cost Comparison

50 g 200 g 500 g 1000 g 2000 g 5000 g 10,000 g$0

$2,000,000

$4,000,000

$6,000,000

$8,000,000

$10,000,000

$12,000,000

Cost Comparison

US Competitor (Cost US$)

AmbioPharm (Cost US$)

Manufacturing Scale

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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