Your strategic partner for cgmp peptide manufacturing and services l.jpg
Sponsored Links
This presentation is the property of its rightful owner.
1 / 27

American Peptide Company: PowerPoint PPT Presentation

  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

American Peptide Company:

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript

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

Slide2 l.jpg

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 l.jpg

Markets Served











Our target market l.jpg

Our target market

Our capabilities l.jpg


Technology Transfer

Process Development

Pilot Scale-Up



Production Campaign

Our Capabilities

Research & Process Development

GMP Manufacturing

Slide7 l.jpg


Phase I

Phase II

Phase III


Process Development

Analytical Development

Analytical Qualification

Analytical Validation

Supportive Stability Studies


Process Qualification

Process Validation

Project management l.jpg









Project Management

Gmp facility vista ca l.jpg

GMP Facility, Vista, CA

Our mission l.jpg

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

Slide11 l.jpg

Our Business

Our history and our future l.jpg

Our History and Our Future

Vista opening

Founded by Itoham

cGMP Manufacturing







FDA audit,

no 483 observations



FDA audit,

no 483 observations

Our commitment l.jpg

Our Commitment

  • Collaboration

  • Delivery

  • Technical Support

  • Dependability

  • GMP Compliance

Slide14 l.jpg

Production System

Material &



Quality System

Lab Controls System

Facilities & Equip System

Packaging & Labeling System

Facilities equipment systems l.jpg

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 l.jpg

Production Control Systems

- QA Controlled documentation System

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

Production control systems17 l.jpg

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 l.jpg

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

Training l.jpg


- Personal responsibilities (i.e, Hygiene)

- GMP Training

- Specific task training

- Outside seminars and training courses

- General training and re-training

Class 100k clean room l.jpg

Class 100K Clean Room

Process flow chart l.jpg

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

Apc organizational chart l.jpg

APC Organizational Chart

Quality organizational chart l.jpg

Quality Organizational Chart

Manufacturing organizational chart l.jpg

Manufacturing Organizational Chart

Slide25 l.jpg

Future Warehouse

Future Synthesis Suites

Future Clean Room

Slide27 l.jpg


  • 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

  • Login