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 Custom Synthesis Catalog Peptides Active Pharmaceutical Ingredients Universities Biotechs Pharmas

Our target market

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

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

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

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 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

Our Commitment Collaboration Delivery Technical Support Dependability GMP Compliance

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

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 Process Flow Chart

APC Organizational Chart

Quality Organizational Chart

Manufacturing Organizational Chart

Future Warehouse Future Synthesis Suites Future Clean Room

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