American Peptide Company:Your Strategic Partner for cGMP Peptide Manufacturing and Services

January 18, 2007

American Peptide Company

• US based cGMP Synthetic Peptide Manufacturer • Provides specialized testing and analytical services

and regulatory support• Diverse range of synthetic chemical strategies,

including SPPS, HPPS, and mixed strategies • Extensive experience in the field of PEGylation for

peptides• In the past 3 years, we have made over 200 APIs for

clinical studies

Markets Served

Universities

Biotechs

Pharmas

Custom Synthesis

Catalog Peptides Active

PharmaceuticalIngredients

Our target market

Our Capabilities

Discovery Technology Transfer

Process Development

Pilot Scale-Up

Clinical

batches

Production Campaign

GMP ManufacturingResearch & Process Development

Preclinical Phase I Phase II Phase III NDA

Process Development

Supportive Stability Studies

Process Validation

Process Qualification

Scale-up

Analytical Development

Analytical Qualification

Analytical Validation

Production

Quality Unit

Development

Business Development

Project Project

ManagerManager

CUSTOMERS

Project Management

GMP Facility, Vista, CA

Our Mission• To develop and optimize manufacturing processes

for the production of biochemical compounds for customers worldwide

• To focus on customer needs and to provide products that satisfy the distinct requirements of each client

• To conduct our business with honesty, integrity, and accountability at all levels

• To create a safe workplace where employees are compliant with all environmental laws

• To be the market-leader by leveraging our presence worldwide and by utilizing advanced technologies in product and process development

Our Business

Our History and Our Future

1988 20021994

cGMP ManufacturingcGMP Manufacturing Vista openingVista openingFounded by ItohamFounded by Itoham

FDA audit, FDA audit, no 483 observationsno 483 observations

VistaVistaExpansionExpansion

2005 20062004

FDA audit, FDA audit, no 483 observationsno 483 observations

Our Commitment

1. Collaboration

2. Delivery

3. Technical Support

4. Dependability

5. GMP Compliance

APC

Quality System

Production System

Lab Controls System

Facilities & Equip System

Packaging & Labeling System

Material &

System

Facilities & Equipment Systems

- Buildings with Environmentally controlled MFG core

(Class 100,000 purification suites/ class 10,000 packaging room)

- Validated systems for water and air handling

- Waste handling systems and emergency power

- Process equipment validated under IQ/OQ/PQ

Production Control Systems

- QA Controlled documentation System

- Raw Materials Handling system ( Receiving, testing, labeling and release )

Production Control Systems- Environmental monitoring of the clean room

- Microbiological monitoring of the water systems

- Specific task training - In Process control Testing , Verification

of critical steps (i.e., Ninhydrin, pH, AAA, HPLC)

Quality Systemsfor Control and Assurance

- QA release of Master BPR specifically for each lot

- QC testing of Raw Materials / QA final release

- QC compilation of results during final testing of drug substance

compared to specifications (incl. C of A)

- Creation of a document set including BPR, SOP’s, list of materials/equipment, list of assays and specifications,

monitoring of intermediates and final product quality

- Document and Drug Substance Physical Control

- Recalls and Complaints, Training, Stability Protocol execution

Training- Personal responsibilities (i.e, Hygiene)

- GMP Training

- Specific task training

- Outside seminars and training courses - General training and re-training

Class 100K Clean Room

Process Flow Chart

Synthesis of the Starting Material

Qualification of Raw Materials

Equipment and Area Preparation

Sequential Addition of Derivatized Amino Acids

Cleavage Peptide from the Support Resin

Reverse Phase and Ion Exchange Column Purification of the Peptide

Final Lyophilization of the Peptide Product

Packaging and Labeling

Move to class 10K clean room packaging room

Label Issuance and Preparation

Final QC testing QA Review and Release

In-process test

In-process test

In-process test

In-process test

APC Organizational ChartPresident & CEO

Chris J. Bai

Research &Production

VPBaosheng Liu

Marketing &Sales

VPGary Hu

Finance &Administration

VPDavid Godkin

Finance & Accounting

DirectorReiko Onishi

Project Management

ManagerRafael Ibarra

Process &cGMP Production

DirectorRuoping Zhang

QualityVP

Shawn Shirzadi

Business Development

VPJim Hampton

SynthesisManagerLiang Liu

PurificationManagerShulan Li

Quality ControlQC Supervisor

Shilpa Patel

PurchasingFred Torres

Marketing &Non-GMP Sales

Account ManagerMellissa Grigsby

Non-GMP SalesAccount Manager

Greg Pagel

Customer ServiceProduct ManagerMaria Graboski

ShippingNancy Yang

AdministrationSherri Dougan

Linda Wakefield

HumanResource

Open

FacilityManagement

Masaya Tsukamoto

GMP SalesManager

Rob Geiger

GMP SalesEurope

Stewart Hamilton

GMP SalesS. KoreaSunjin Oh

Quality ControlManager

Scott Caton

Quality AssuranceSpecialist

Mitra Yaghmai

Material Management

ManagerScott Caton

SynthesisManager

Qingchai Xu

PurificationManager

Gabe Smith

ProcessDevelopment

ManagerQingchai Xu

ProjectManagementCoordinator

Shannon Doyle

PurchasingShippingInvoicing

Shannon Doyle

ValidationSpecialist

Rafael Ibarra

Non-GMP SalesJapan, Europe,

China & S. Korea

GMP SalesChina

Samuel Zhang

Quality Organizational Chart

Vice President QualityShawn Shirzadi

Quality AssuranceQA Consultants

Quality Assurance Manager(Open)

Quality Control ManagerScott Caton

Quality Control SupervisorChae Chang

Quality Assurance SpecialistTeresita De Soto

Sr. Quality Control AnalystSuza Radic

Quality Assurance SpecialistMitra Yaghmai

QC Analyst (Microbiology)Jun Clemente

Materials ManagementChat Gardner

Materials CoordinatorJames Callison

QC AnalystOlga Sannikova

Manufacturing Organizational ChartManufacturing Director

Ruoping Zhang

Synthesis ManagerQingchai Xu, Ph.D.

Purification ManagerGabe Smith

ChemistJer Hong Chong

ChemistTeruyohi Fujimore

ChemistNguyen Thai

ChemistPeter Curtiss

ChemistShane R. Dailey

ChemistDengguo Wu

ChemistSak Khammungkhune

ChemistYadong Liu

ChemistPatricia De Leon

ChemistHoward Chan

ChemistSylvia Xue-Fei Xu

ChemistTiffany Thai

ChemistZenith Khan

Instrument SpecialistYumin Han

Lab TechnicianJustin Bogart

Future Clean RoomFuture Synthesis Suites

Future Warehouse

Conclusion

• Made over 15,000 sequences many of which have progressed to over 200 APIs made in last 3 years alone

• Creating long-term business relations• Focused on customer needs • Provide products and services that satisfy the

requirements of each client