APC American Peptide Company by yurtgc548

VIEWS: 7 PAGES: 27

									                   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
Universities
                                Ingredients
Biotechs
Pharmas
Our target market
                   Our Capabilities
Discovery   Technology     Process       Pilot    Production   Clinical
             Transfer    Development              Campaign
                                       Scale-Up
                                                               batches




             Research & Process Development         GMP Manufacturing
Preclinical        Phase I                   Phase II       Phase III         NDA



                    Process Development

 Analytical    Analytical       Analytical
Development   Qualification     Validation




              Supportive Stability Studies



                              Scale-up        Process Qualification Process Validation
              Project Management
                   Production



 Business          Project      Quality Unit
Development
                   Manager



                  Development

                 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          cGMP Manufacturing     Vista opening



       1988                  1994                    2002


       2004                2005                      2006


     FDA audit,             FDA audit,              Vista
     no 483 observations    no 483 observations     Expansion
    Our Commitment

Π  Collaboration
   Delivery
Ž   Technical Support
   Dependability
   GMP Compliance
                      Production System




Material &                 APC              Lab
System                                      Controls
                         Quality            System
                         System



 Facilities & Equip                   Packaging &
 System                               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
          Qualification    Synthesis of       Equipment
          of Raw           the Starting       and Area
          Materials        Material           Preparation




Process                    Sequential
                           Addition of
                                            In-process test



 Flow
                           Derivatized
                           Amino Acids



                           Cleavage



 Chart
                           Peptide from     In-process test
                           the Support
                           Resin




                          Reverse
                          Phase and Ion
                          Exchange            In-process test
                          Column
                          Purification of
                          the Peptide




                          Final
                          Lyophilization      In-process test
                          of the Peptide
                          Product




                          Move to class
                          10K clean room
                          packaging room



                             Packagin
          Label              g and             Final QC testing
          Issuance and       Labeling          QA Review and
          Preparation                          Release
                                     APC Organizational Chart
                                                                                         President & CEO
                                                                                           Chris J. Bai




                                                                                              Business                                                                            Project
 Research &                      Marketing &                 Finance &                                                                                Process &
                                                                                            Development                    Quality                                              Management
 Production                        Sales                    Administration                                                                         cGMP Production
                                                                                                 VP                          VP                                                  Manager
    VP                               VP                          VP                                                                                    Director
                                                                                            Jim Hampton                 Shawn Shirzadi                                          Rafael Ibarra
Baosheng Liu                      Gary Hu                   David Godkin                                                                            Ruoping Zhang




                                             Marketing &                      Finance &                                                                                                            Project
                 Synthesis                                                                                 GMP Sales                 Quality Control              Synthesis
                                           Non-GMP Sales                     Accounting                                                                                                          Management
                 Manager                                                                                    Manager                    Manager                    Manager
                                           Account Manager                     Director                                                                                                          Coordinator
                 Liang Liu                                                                                 Rob Geiger                 Scott Caton                Qingchai Xu
                                           Mellissa Grigsby                  Reiko Onishi                                                                                                       Shannon Doyle




                                                                                                                                                                                                 Purchasing
                Purification               Non-GMP Sales                  Administration                 GMP Sales                 Quality Assurance             Purification
                                                                                                                                                                                                  Shipping
                 Manager                   Account Manager                Sherri Dougan                   Europe                      Specialist                  Manager
                                                                                                                                                                                                  Invoicing
                 Shulan Li                   Greg Pagel                  Linda Wakefield              Stewart Hamilton              Mitra Yaghmai                Gabe Smith
                                                                                                                                                                                                Shannon Doyle




                                           Customer Service                                                                               Material                 Process
               Quality Control                                                 Human                       GMP Sales                                                                              Validation
                                           Product Manager                                                                               Management              Development
               QC Supervisor                                                  Resource                      S. Korea                                                                              Specialist
                                            Maria Graboski                                                                                Manager                 Manager
                Shilpa Patel                                                    Open                       Sunjin Oh                                                                             Rafael Ibarra
                                                                                                                                         Scott Caton             Qingchai Xu




                                           Non-GMP Sales                    Facility                       GMP Sales
                Purchasing
                                            Japan, Europe,               Management                          China
                Fred Torres
                                           China & S. Korea            Masaya Tsukamoto                   Samuel Zhang




                                                Shipping
                                               Nancy Yang
        Quality Organizational Chart
                                                               Vice President Quality
                                                                  Shawn Shirzadi

Quality Assurance              Quality Assurance Manager                                Quality Control Manager
 QA Consultants                          (Open)                                               Scott Caton

           Quality Assurance Specialist           Quality Assurance Specialist          Quality Control Supervisor
                 Teresita De Soto                       Mitra Yaghmai                          Chae Chang



  QC Analyst               Sr. Quality Control Analyst      QC Analyst (Microbiology)       Materials Coordinator    Materials Management
 Olga Sannikova                    Suza Radic                    Jun Clemente                 James Callison             Chat Gardner
Manufacturing Organizational Chart
                                                           Manufacturing Director
                                                              Ruoping Zhang




                    Synthesis Manager                                                              Purification Manager
                    Qingchai Xu, Ph.D.                                                                  Gabe Smith




      Chemist                                Chemist                                Chemist                                    Chemist
  Jer Hong Chong                         Teruyohi Fujimore                      Patricia De Leon                             Howard Chan




    Chemist                                  Chemist                                Chemist                                     Chemist
   Nguyen Thai                             Peter Curtiss                       Sylvia Xue-Fei Xu                              Tiffany Thai




     Chemist                                 Chemist                                  Chemist                             Instrument Specialist
  Shane R. Dailey                          Dengguo Wu                               Zenith Khan                                Yumin Han




      Chemist                                Chemist                            Lab Technician
Sak Khammungkhune                           Yadong Liu                           Justin Bogart
                      se
                  ehou
            re War
     Futu




Future
Synthesis            Future Clean Room
Suites
                 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

								
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