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American Peptide Company:

Your Strategic Partner for cGMP Peptide Manufacturing and Services. American Peptide Company:. January 18, 2007. American Peptide Company. US based cGMP Synthetic Peptide Manufacturer Provides specialized testing and analytical services and regulatory support

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American Peptide Company:

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  1. Your Strategic Partner for cGMP Peptide Manufacturing and Services American Peptide Company: 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

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

  6. 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

  7. Production Project Manager QualityUnit Business Development Development CUSTOMERS Project Management

  8. GMP Facility, Vista, CA

  9. 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

  10. Our Business

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

  12. Our Commitment • Collaboration • Delivery • Technical Support • Dependability • GMP Compliance

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

  14. 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

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

  16. 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)

  17. Quality Systemsfor 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

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

  19. Class 100K Clean Room

  20. Qualification of Raw Materials Synthesis of the Starting Material Equipment and Area Preparation Sequential Addition of Derivatized Amino Acids In-process test 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 10K clean room packaging room Label Issuance and Preparation Packaging and Labeling Final QC testing QA Review and Release Process Flow Chart

  21. APC Organizational Chart

  22. Quality Organizational Chart

  23. Manufacturing Organizational Chart

  24. Future Warehouse Future Synthesis Suites Future Clean Room

  25. 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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