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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

American Peptide Company:

January 18, 2007


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

Custom

Synthesis

Catalog

Peptides

Active

Pharmaceutical

Ingredients

Universities

Biotechs

Pharmas


Our target market


Discovery

Technology Transfer

Process Development

Pilot Scale-Up

Clinical

batches

Production Campaign

Our Capabilities

Research & Process Development

GMP Manufacturing


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


Production

Project

Manager

QualityUnit

Business

Development

Development

CUSTOMERS

Project Management


GMP Facility, Vista, CA


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


Our Business


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


Our Commitment

  • Collaboration

  • Delivery

  • Technical Support

  • Dependability

  • GMP Compliance


Production System

Material &

System

APC

Quality System

Lab Controls System

Facilities & Equip System

Packaging & Labeling System


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

- QA Controlled documentation System

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


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 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

- Personal responsibilities (i.e, Hygiene)

- GMP Training

- Specific task training

- Outside seminars and training courses

- General training and re-training


Class 100K Clean Room


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


Quality Organizational Chart


Manufacturing Organizational Chart


Future Warehouse

Future Synthesis Suites

Future Clean Room


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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