1. American Peptide Company:
Your Strategic Partner for cGMP Peptide Manufacturing and Services
January 18, 2007

2. 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

3. Markets Served Custom Synthesis Catalog Peptides Active Pharmaceutical
Ingredients
Universities
Biotechs
Pharmas

4. Our target market

6. Research & Process Development
Our Capabilities
Discovery
Technology Transfer
Process Development
Pilot Scale-Up
Production Campaign
Clinical
batches
Research & Process Development
GMP Manufacturing

7. Process Development Supportive Stability Studies
Preclinical
Phase I
Phase II
Phase III
NDA
Process Development
Analytical Development
Analytical Qualification
Analytical Validation
Supportive Stability Studies
Scale-up
Process Qualification
Process Validation

8. Project Management CUSTOMERS Production Project Manager Quality Unit
Development
Business
Project
Manager
CUSTOMERS

9. GMP Facility, Vista, CA

10. 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

11. Our Business

12. Our History and Our Future
Founded by Itoham
Vista opening
cGMP Manufacturing
1994
1988
2002
2005
2006
2004
FDA audit,
no 483 observations
FDA audit,
no 483 observations
Vista
Expansion

13. Our Commitment Collaboration Delivery Technical Support Dependability
GMP Compliance

14. APC Quality System Production System Material & Lab Controls System
Facilities & Equip System
Packaging & Labeling System

15. 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

16. Production Control Systems
- QA Controlled documentation System
- Raw Materials Handling system ( Receiving, testing, labeling and release )

17. 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)

18. Quality Systems for 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

19. Training - Personal responsibilities (i.e, Hygiene) - GMP Training
- Specific task training
- Outside seminars and training courses
- General training and re-training

20. Class 100K Clean Room

21. 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
Process Flow Chart

22. APC Organizational Chart

23. Quality Organizational Chart

24. Manufacturing Organizational Chart

25. Future Warehouse
Future Synthesis Suites
Future Clean Room

27. 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