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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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Your strategic partner for cgmp peptide manufacturing and services l.jpg

Your Strategic Partner for cGMP Peptide Manufacturing and Services

American Peptide Company:

January 18, 2007

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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

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Markets Served











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Our target market

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Technology Transfer

Process Development

Pilot Scale-Up



Production Campaign

Our Capabilities

Research & Process Development

GMP Manufacturing

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Phase I

Phase II

Phase III


Process Development

Analytical Development

Analytical Qualification

Analytical Validation

Supportive Stability Studies


Process Qualification

Process Validation

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Project Management

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GMP Facility, Vista, CA

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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

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Our Business

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Our History and Our Future

Vista opening

Founded by Itoham

cGMP Manufacturing







FDA audit,

no 483 observations



FDA audit,

no 483 observations

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Our Commitment

  • Collaboration

  • Delivery

  • Technical Support

  • Dependability

  • GMP Compliance

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Production System

Material &



Quality System

Lab Controls System

Facilities & Equip System

Packaging & Labeling System

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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

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Production Control Systems

- QA Controlled documentation System

- Raw Materials Handling system ( Receiving, testing, labeling and release )

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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)

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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

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- Personal responsibilities (i.e, Hygiene)

- GMP Training

- Specific task training

- Outside seminars and training courses

- General training and re-training

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Class 100K Clean Room

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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

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APC Organizational Chart

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Quality Organizational Chart

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Manufacturing Organizational Chart

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Future Warehouse

Future Synthesis Suites

Future Clean Room

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  • 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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