American Peptide Co. Overview

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  • Legit supplier of HGH, GHRP-2, GHRP-6, Melanotan 2, CJC 1295 With DAC, Modified GRF(1-29), MGF, PEG-MGF, TB500, IGF-1 LR3, HCG, HGH-FRAGMENT, AOD-9604, HMG, Ipamorelin, PT-141, DSIP, Selank, FTPP, Epitalon, Follistatin 344 and ACE-031 etc. Manufacturer of highest quality Peptides & HGH with a Purity above 98.6% . PAYPAL ACCEPT, contace me adapeptide@gmail.com or sent pm please !
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American Peptide Co. Overview

  1. 1. APC Overview<br />American Peptide Company, Inc. :your strategic partner forpeptide manufacturing and services<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />2010 – v3.01<br />
  2. 2. APC Corporate Facts and History<br />1987<br />1994<br />1998<br />2002<br />2005<br />2003<br />2007<br />2008<br />- GMP License<br />- Ito Life Sciences <br /> Founded<br />- GMP facility<br /> expansion <br />- Founded<br />- New GMP <br /> facility in Vista (30,000sq.)<br />Itoham Foods, Japan<br />- Acquisition <br />by Otsuka Chemical<br />- Launch website<br />- FDA inspected GMP facility<br />- 2 -<br />
  3. 3. APC Organization<br />CEO<br />Seiji Sato, Ph.D.<br />President & COO<br />Hiro (Takahiro) Ogata<br />GMP Manufacturing VP<br />Jianjun (JJ) Jiang, Ph.D.<br />Quality, VP<br />Shawn Shirzadi<br />Research & Production, VP<br />Baosheng Liu, Ph.D.<br />Sales & Marketing VP<br />Gary Hu<br />Finance & Administration, VP<br />David Godkin<br />Research & Production <br />V.P.<br />Director, GMP Manufacturing<br />Patricia Haller, Ph.D.<br />Director, GMP Quality Control<br />Scott Caton<br />Finance<br />Director, Sales<br />Firuz Shakoori<br />Synthesis<br />Purification<br />Sales<br />Accounting & <br />Finance<br />Quality Control<br />Synthesis<br />Marketing<br />Process Development<br />Administration<br />Material Management<br />Purification<br />Customer Service<br />Quality Control<br />Human Resource<br />Process Development<br />Quality Assurance<br />Project/Product Management<br />Purchasing<br />Shipping<br />- 3 -<br />
  4. 4. APC Company Overview<br />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. <br />- 4 -<br />
  5. 5. APC Facilities <br />Headquarters<br />777 East Evelyn Ave.<br />Sunnyvale, CA 94086 USA<br />Tel: 408-733-7604 or 1-800-926-8272<br />Fax: 408-733-7603 or 1-888-670-0070 <br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />cGMP Manufacturing Facility<br />1271 Avenida Chelsea<br />Vista, CA 92081 USA <br />Tel: 760-597-8820<br />Fax: 760-597-8816<br />- 5 -<br />
  6. 6. Our Mission<br />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.<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />- 6 -<br />
  7. 7. © Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Research & Process Development<br />GMP Manufacturing<br />Our Capabilities<br />Discovery<br />Technology <br />Transfer<br />Process <br />Development<br />Pilot <br />Scale-up<br />Production <br />Campaign<br />Clinical <br />Batches<br />- 7 -<br />
  8. 8. Manage & Support <br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Preclinical<br />Phase 1<br />Phase 2<br />Phase 3<br />NDA<br />Process Development<br />Analytical<br />Qualification<br />Analytical<br />Validation<br />Analytical<br />Development<br />Supportive Stability Studies<br />Process <br />Qualification<br />Process Validation<br />Scale-up<br />- 8 -<br />
  9. 9. Products and Services <br />Custom <br />Synthesis<br />cGMP - Active Pharmaceutical Ingredients<br />Catalog<br />Peptide<br />- 9 -<br />
  10. 10. Catalog Peptides<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Custom <br />Synthesis<br /><ul><li>About 1,500 Products
  11. 11. Bioactive Peptides
  12. 12. Substrate & Inhibitors
  13. 13. Fluorescent Materials
  14. 14. Quick Label Derivative</li></ul>cGMP - Active Pharmaceutical Ingredients<br />Catalog<br />Peptide<br />- 10 -<br />
  15. 15. Custom Synthesis<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br /><ul><li>Small scale to large scale
  16. 16. Peptide Arrays
  17. 17. Organic Synthesis
  18. 18. Process Development
  19. 19. Contract Manufacturing
  20. 20. New Products</li></ul>cGMP - Active Pharmaceutical Ingredients<br />Catalog<br />Peptide<br />Custom <br />Synthesis<br />- 11 -<br />
  21. 21. cGMP-Active Pharmaceutical Ingredients (APIs)<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Generic & Custom Synthesis<br /><ul><li>Custom sequences
  22. 22. Glucagon, human
  23. 23. Leuprolide
  24. 24. Octreotide
  25. 25. Fertirelin
  26. 26. Calcitonin, salmon
  27. 27. CRF, human, rat
  28. 28. Brain Natriuretic Peptide, human
  29. 29. Thymopentin (TP-5)
  30. 30. ACTH (corticotropin)
  31. 31. Elcatonin
  32. 32. Beta Amyloid (1-42), human
  33. 33. Triptorelin
  34. 34. Buserelin
  35. 35. Thymosin a-1
  36. 36. Somatostatin 14
  37. 37. Exendin (9-39)</li></ul>cGMP - Active Pharmaceutical Ingredients<br />Catalog<br />Peptide<br />Custom <br />Synthesis<br />- 12 -<br />
  38. 38. Peptide Modifications<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br /><ul><li>Oligosaccharides
  39. 39. 5-lodoacetamido Fluorescein
  40. 40. AFC
  41. 41. AMC
  42. 42. Biotin
  43. 43. Bodipy
  44. 44. BSA/KLH Conjugation
  45. 45. Coumarin
  46. 46. Cyclic peptide
  47. 47. Cy3 and Cy5
  48. 48. Dabcyl
  49. 49. Dansyl
  50. 50. Ser (octanoic acid)
  51. 51. Stearic acid modification
  52. 52. TAMRA</li></ul> (Tetramethylrhodamine)<br /><ul><li>Texas Red
  53. 53. Sulfated peptide [Tyr(SO3)]
  54. 54. EDANS
  55. 55. Farnesyl
  56. 56. FITC
  57. 57. MAPS
  58. 58. MCA
  59. 59. Palmitoyl
  60. 60. PEGylation
  61. 61. Phosphorylation
  62. 62. PNA
  63. 63. Rhodamine 110
  64. 64. Rhodamine B</li></ul>- 13 -<br />
  65. 65. © Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Our Customers (to name a few)<br />- 14 -<br />
  66. 66. Distributors<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />- 15 -<br />
  67. 67. © Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Our Target Market<br />Custom <br />Synthesis<br />Catalog<br />Peptide<br />cGMP - APIs<br /><ul><li>Pharmas
  68. 68. Biotechs
  69. 69. Academics</li></ul>USA,Canada,Japan,Europe,Korea,China,India,South Africa,Australia, Netherlands <br />- 16 -<br />
  70. 70. Project Management<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Customer<br />Account Manager<br />Project Manager<br />Quality <br />Business Development<br />Manufacturing<br />- 17 -<br />
  71. 71. Synthesis of the Starting Material<br />Peptide Process<br />Sequential Additional of Derivatized Amino Acids<br />Equipment and Area Preparation<br />Qualification of Raw Materials<br />Cleavage Peptide from the Support Resin<br />In process test<br />Reverse Phase and Ion Exchange Column Purification of the Peptide<br />In process test<br />Final Lyophilization of the Peptide Product<br />In process test<br />Move to Class 10 K clean room packaging room<br />In process test<br />Packaging and Labeling<br />Final QC Testing QA Review and Release<br />Label Issuance and Preparation<br />- 18 -<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />
  72. 72. Technical Capabilities<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Synthesis:<br /><ul><li> Solid Phase
  73. 73. Solution Phase
  74. 74. Combination
  75. 75. Common </li></ul> Strategies<br />Analysis:<br />- Purity<br />- Identity<br />- Content<br />Purification:<br />- Method & Tools<br />- 19 -<br />
  76. 76. Technical Capabilities - Synthesis<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Synthesis:<br /><ul><li> Solid Phase
  77. 77. Solution Phase
  78. 78. Combination
  79. 79. Common Strategies
  80. 80. Strategy: Boc, Fmoc, Cbz
  81. 81. Current capacity: up to 80L (solid), 200L (solution) reaction volume
  82. 82. Batch Size: up to 2Kg per batch of synthetic peptides depending on the sequence
  83. 83. Expansion: 3X current capacity, 10Kg per batch depending on sequence</li></ul>- 20 -<br />
  84. 84. Technical Capabilities - Purification<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br /><ul><li>Preparative HPLC:</li></ul> 1/4 inch to 12 inch columns<br />Purification:<br />- Method & Tools<br /><ul><li>Conventional Chromatography:
  85. 85. ion exchange
  86. 86. SEC
  87. 87. Gel Chromatography</li></ul>- 21 -<br />
  88. 88. Technical Capabilities - Analysis<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Methods:<br /><ul><li> HPLC, TLC, GC
  89. 89. MS, IR, NMR*, UV
  90. 90. Chiral analysis
  91. 91. AAA
  92. 92. Elemental analysis*
  93. 93. Heavy metals*
  94. 94. Bioburden
  95. 95. Endotoxin
  96. 96. Residual Solvents *
  97. 97. Water Content</li></ul>*contract labs<br />Samples:<br /><ul><li> incoming materials</li></ul> amino acids<br /> solvents<br /> reagents<br /> others<br /> “BSE free”<br /><ul><li> intermediate
  98. 98. final products</li></ul>Analysis:<br />- Purity<br />- Identity<br />- Content<br />- 22 -<br />
  99. 99. GMP Facility Expansion: Stage 2 (completed in 2009)<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Purification:<br /><ul><li> Four additional purification suites: </li></ul> Classified as class 100,000 (ISO-8). <br /><ul><li> Additional 6 thru 12 inch columns.
  100. 100. Additional walk-in refrigerator to be shared </li></ul> by the purification suites. <br />Lyophilization:<br /><ul><li> Two of 30Ls and 50L </li></ul> capacity tray lyophilizers<br /> in dedicated suite. <br />QC:<br /><ul><li>Optical Rotation analysis equipment
  101. 101. UPLC (analysis for HPLC, LCMS, AAA)
  102. 102. TOC (Total organic carbon analyzer)</li></ul>50 L lyophilizer<br />- 23-<br />
  103. 103. GMP Facility Expansion: Stage 3<br />© Copyright 2010 American Peptide Company Inc., All Rights Reserved<br />Synthesis:<br /><ul><li> Two additional synthesis suites: </li></ul>Solution phase and Solid phase. <br />For Solution phase: 3 reactors: 1000L, 1500L, and 2000L. <br />These reactors will be jacketed in order to control / <br />maintain reaction temperature, and due to their large size, <br />would be accessible by a 2nd floor steel platform. <br /><ul><li> For Solid phase synthesis: Reactors from 200L - 500L.
  104. 104. Increase in chemical usage and waste: additional space </li></ul> for solvent storage.<br />200 L reactor<br />Lyophilization:<br /><ul><li> Additional 200L capacity tray lyophilizer in dedicated suite. </li></ul>- 24 -<br />
  105. 105. Conclusion<br /><ul><li> Made over 20,000 sequences many of which have </li></ul> progressed to over 200 APIs made in last 3 years alone.<br /><ul><li> Extensive experience from mg to multi-kg scale
  106. 106. Conjugation & PEGylation experience
  107. 107. Creating long-term business relations
  108. 108. Growth potential</li></ul>- 25 -<br />
  109. 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.<br />- 26 -<br />

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