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cGMP Peptide Manufacturing

With more than a decade of committed service to the peptide industry, CPC Scientific is a trusted provider of high-quality peptides to researchers and pharmaceutical companies all over the world. The CPC Group is comprised of peptide experts who have actively pursued peptide design and large scale manufacturing for more than 30 years, so your project is in good hands.    CPC Scientific is the ideal peptide partner from concept to commercial for all of your cGMP needs.

Expertise

Extensive knowledge developed through years of experience in the peptide industry is at your disposal.

  • SPPS, LPPS, ligation chemistry and fragment condensation methodologies
  • All protecting strategies (Boc, Fmoc, Cbz) can be used
  • Innovative purification and isolation techniques employed
  • Process development and scale-up competence insures a robust commercial process
  • Complex sequences and peptide modifications adapted to large-scale production

 

High-Capacity cGMP Production Facility

CPC is expanding our manufacturing facility to better support your cGMP needs.

  • 60,000 ft2 currently in operation
  • 150,000 ft2 expansion in build out (Commission planned April 2015)
  • GMP batch sizes from gram scale to multi-kilogram scale
  • Qualified air and water systems
  • IQ, OQ, PQ qualified equipment
  • Class 100K, 10K, and 1K clean rooms

 

Fully-Equipped Manufacturing Laboratories

CPC has an extensive portfolio of manufacturing equipment installed and qualified to produce cGMP-grade peptides in every stage.

Synthesis

  • Reactors with multiple volumes (20 - 2,000 L)
  • Hybrid synthesis reactor

Purification

  • Preparative HPLC systems with multiple flow rates
  • Chromatography columns with various inner diameters (up to 18 in)
  • Fast protein liquid chromatography (FPLC) systems

Isolation

  • Blenders and evaporators
  • Manifold lyophilizers
  • Tray lyophilizers

 

Quality Systems

A dedicated Quality department verifies full cGMP compliance throughout production, as well as testing and documentation standards in accordance with the most stringent FDA requirements.

  • In-process, release and environmental control testing performed
  • Standard release testing performed in-house
  • Audited contract laboratories available for additional testing
  • Method development and validation, formal method transfer
  • Stability studies (ICH) and forced degradation
  • Process development support (peak homogeneity, impurity characterization)

A typical cGMP peptide is tested at CPC using the following methods:

  • Appearance
  • Solubility
  • Purity (HPLC, UPLC)
  • Molecular weight (MS)
  • AAA
  • Peptide content
  • Counter-ion content
  • Moisture content (Karl Fisher)
  • Residual solvents
  • Bioburden
  • Endotoxin

Additionally, our QC department is fully equipped and additional analysis can be performed upon request. 

 

Quality Assurance

CPC Scientific provides complete support for your IND and NDA filings in the USA as well as all international filings and all required regulatory support for your peptide APIs.

Quality assurance

  • Batch record review
  • Document management and control
  • Deviations/Investigations
  • CAPA follow up and tracking
  • Complaint management
  • Product release

Regulatory support

  • Phase appropriate control systems consulting
  • CMC compilation
  • DMF compilation and submission
  • Annual product reviews

 

Regulatory Compliance

CPC manufactures cGMP-grade peptides under strict compliance. Our GMP program meets FDA and international regulatory guidances. 

  • 21 CFR 210/211 (Code of Federal Regulations Title 21, Chapter 1, Subchapter C, Parts 210 and 211)
  • ICH Q7 (ICH Harmonised Tripartite Guideline, Good Manufacturing Practice for Active Pharmaceutical Ingredients Q7)
  • Full compliance license in cGMP manufacturing of peptides and intermediates (Chinese FDA)
  • US FDA inspected (twice): no Form 483 observations
  • ISO 9001 certified (2008)
  • ISO 13485 certified (2008) – medical devices
  • PMDA registered (Japan, 2008)

 

Generic peptide APIs available or in development

  • Leuprorelin acetate
  • Triptorelin acetate
  • Exenatide acetate
  • Terlipressin acetate
  • Liraglutide
  • Degarelix

 

Project Management

We will work closely with you throughout the project and adopt any previous chemistries that can shorten your clinical trials and reduce the risks in clinical filing complications.

  • Project tracking
  • Liaison to CPC operation
  • Cross-functional links from CPC operation to customer operation
  • Project history documentation
  • Customer-centric collaboration

 

Confidentiality

The satisfaction of our customers is the most important reason for our continued growth and success. One critical ingredient is maintaining the confidentiality of trade secrets and proprietary information released to us by our customers. CPC will assure the complete confidentiality of all proprietary information we receive during the course of fulfilling any of our custom services.

 

Complete Product Lifecycle Support

CPC Scientific provides comprehensive product lifecycle support at every phase.

  • Discovery
  • Preclinical
  • Clinical
  • Commercial