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American Peptide Co. Overview
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  • 1. APC Overview
    American Peptide Company, Inc. :your strategic partner forpeptide manufacturing and services
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    2010 – v3.01
  • 2. APC Corporate Facts and History
    1987
    1994
    1998
    2002
    2005
    2003
    2007
    2008
    - GMP License
    - Ito Life Sciences
    Founded
    - GMP facility
    expansion
    - Founded
    - New GMP
    facility in Vista (30,000sq.)
    Itoham Foods, Japan
    - Acquisition
    by Otsuka Chemical
    - Launch website
    - FDA inspected GMP facility
    - 2 -
  • 3. APC Organization
    CEO
    Seiji Sato, Ph.D.
    President & COO
    Hiro (Takahiro) Ogata
    GMP Manufacturing VP
    Jianjun (JJ) Jiang, Ph.D.
    Quality, VP
    Shawn Shirzadi
    Research & Production, VP
    Baosheng Liu, Ph.D.
    Sales & Marketing VP
    Gary Hu
    Finance & Administration, VP
    David Godkin
    Research & Production
    V.P.
    Director, GMP Manufacturing
    Patricia Haller, Ph.D.
    Director, GMP Quality Control
    Scott Caton
    Finance
    Director, Sales
    Firuz Shakoori
    Synthesis
    Purification
    Sales
    Accounting &
    Finance
    Quality Control
    Synthesis
    Marketing
    Process Development
    Administration
    Material Management
    Purification
    Customer Service
    Quality Control
    Human Resource
    Process Development
    Quality Assurance
    Project/Product Management
    Purchasing
    Shipping
    - 3 -
  • 4. APC Company Overview
    We offer a comprehensive selection of pre-manufactured catalog peptides in convenient aliquots, a spectrum of custom synthesis services from array screens to mg to kg of research-grade peptide, and full-scale cGMP manufacturing of pharmaceutical-grade peptides. APC is dedicated to delivering high-quality peptides to pharmaceutical and biotech companies.
    - 4 -
  • 5. APC Facilities
    Headquarters
    777 East Evelyn Ave.
    Sunnyvale, CA 94086 USA
    Tel: 408-733-7604 or 1-800-926-8272
    Fax: 408-733-7603 or 1-888-670-0070
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    cGMP Manufacturing Facility
    1271 Avenida Chelsea
    Vista, CA 92081 USA
    Tel: 760-597-8820
    Fax: 760-597-8816
    - 5 -
  • 6. Our Mission
    To be the industry leader in peptide process development by providing high quality compounds and services coupled with knowledgeable customer support from early stage research to downstream commercial grade quantities.
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    - 6 -
  • 7. © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Research & Process Development
    GMP Manufacturing
    Our Capabilities
    Discovery
    Technology
    Transfer
    Process
    Development
    Pilot
    Scale-up
    Production
    Campaign
    Clinical
    Batches
    - 7 -
  • 8. Manage & Support
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Preclinical
    Phase 1
    Phase 2
    Phase 3
    NDA
    Process Development
    Analytical
    Qualification
    Analytical
    Validation
    Analytical
    Development
    Supportive Stability Studies
    Process
    Qualification
    Process Validation
    Scale-up
    - 8 -
  • 9. Products and Services
    Custom
    Synthesis
    cGMP - Active Pharmaceutical Ingredients
    Catalog
    Peptide
    - 9 -
  • 10. Catalog Peptides
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Custom
    Synthesis
    • About 1,500 Products
    • 11. Bioactive Peptides
    • 12. Substrate & Inhibitors
    • 13. Fluorescent Materials
    • 14. Quick Label Derivative
    cGMP - Active Pharmaceutical Ingredients
    Catalog
    Peptide
    - 10 -
  • 15. Custom Synthesis
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    • Small scale to large scale
    • 16. Peptide Arrays
    • 17. Organic Synthesis
    • 18. Process Development
    • 19. Contract Manufacturing
    • 20. New Products
    cGMP - Active Pharmaceutical Ingredients
    Catalog
    Peptide
    Custom
    Synthesis
    - 11 -
  • 21. cGMP-Active Pharmaceutical Ingredients (APIs)
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Generic & Custom Synthesis
    cGMP - Active Pharmaceutical Ingredients
    Catalog
    Peptide
    Custom
    Synthesis
    - 12 -
  • 38. Peptide Modifications
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    (Tetramethylrhodamine)
    - 13 -
  • 65. © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Our Customers (to name a few)
    - 14 -
  • 66. Distributors
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    - 15 -
  • 67. © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Our Target Market
    Custom
    Synthesis
    Catalog
    Peptide
    cGMP - APIs
    USA,Canada,Japan,Europe,Korea,China,India,South Africa,Australia, Netherlands
    - 16 -
  • 70. Project Management
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Customer
    Account Manager
    Project Manager
    Quality
    Business Development
    Manufacturing
    - 17 -
  • 71. Synthesis of the Starting Material
    Peptide Process
    Sequential Additional of Derivatized Amino Acids
    Equipment and Area Preparation
    Qualification of Raw Materials
    Cleavage Peptide from the Support Resin
    In process test
    Reverse Phase and Ion Exchange Column Purification of the Peptide
    In process test
    Final Lyophilization of the Peptide Product
    In process test
    Move to Class 10 K clean room packaging room
    In process test
    Packaging and Labeling
    Final QC Testing QA Review and Release
    Label Issuance and Preparation
    - 18 -
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
  • 72. Technical Capabilities
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Synthesis:
    Strategies
    Analysis:
    - Purity
    - Identity
    - Content
    Purification:
    - Method & Tools
    - 19 -
  • 76. Technical Capabilities - Synthesis
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Synthesis:
    • Solid Phase
    • 77. Solution Phase
    • 78. Combination
    • 79. Common Strategies
    • 80. Strategy: Boc, Fmoc, Cbz
    • 81. Current capacity: up to 80L (solid), 200L (solution) reaction volume
    • 82. Batch Size: up to 2Kg per batch of synthetic peptides depending on the sequence
    • 83. Expansion: 3X current capacity, 10Kg per batch depending on sequence
    - 20 -
  • 84. Technical Capabilities - Purification
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    • Preparative HPLC:
    1/4 inch to 12 inch columns
    Purification:
    - Method & Tools
    • Conventional Chromatography:
    • 85. ion exchange
    • 86. SEC
    • 87. Gel Chromatography
    - 21 -
  • 88. Technical Capabilities - Analysis
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Methods:
    *contract labs
    Samples:
    • incoming materials
    amino acids
    solvents
    reagents
    others
    “BSE free”
    • intermediate
    • 98. final products
    Analysis:
    - Purity
    - Identity
    - Content
    - 22 -
  • 99. GMP Facility Expansion: Stage 2 (completed in 2009)
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Purification:
    • Four additional purification suites:
    Classified as class 100,000 (ISO-8).
    • Additional 6 thru 12 inch columns.
    • 100. Additional walk-in refrigerator to be shared
    by the purification suites.
    Lyophilization:
    • Two of 30Ls and 50L
    capacity tray lyophilizers
    in dedicated suite.
    QC:
    • Optical Rotation analysis equipment
    • 101. UPLC (analysis for HPLC, LCMS, AAA)
    • 102. TOC (Total organic carbon analyzer)
    50 L lyophilizer
    - 23-
  • 103. GMP Facility Expansion: Stage 3
    © Copyright 2010 American Peptide Company Inc., All Rights Reserved
    Synthesis:
    • Two additional synthesis suites:
    Solution phase and Solid phase.
    For Solution phase: 3 reactors: 1000L, 1500L, and 2000L.
    These reactors will be jacketed in order to control /
    maintain reaction temperature, and due to their large size,
    would be accessible by a 2nd floor steel platform.
    • For Solid phase synthesis: Reactors from 200L - 500L.
    • 104. Increase in chemical usage and waste: additional space
    for solvent storage.
    200 L reactor
    Lyophilization:
    • Additional 200L capacity tray lyophilizer in dedicated suite.
    - 24 -
  • 105. Conclusion
    • Made over 20,000 sequences many of which have
    progressed to over 200 APIs made in last 3 years alone.
    • Extensive experience from mg to multi-kg scale
    • 106. Conjugation & PEGylation experience
    • 107. Creating long-term business relations
    • 108. Growth potential
    - 25 -
  • 109. Total Peptide Management™ is to bring our product portfolio and customer support capabilities to each individual client with efficient, high quality and cost effective peptide management solutions.
    - 26 -