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cGMP Peptide Manufacturing


   Full-Service Peptide CDMO and CRO – New State-of-the-Art GMP Manufacturing Facility  


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.





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


CPC has expanded our manufacturing facility to better support your CGMP needs.

  • 750,000 sq ft currently in operation
  • 160,000 sq ft expansion in build out
  • GMP batch sizes from gram scale to multi-kilogram scale (up to 20 kg per batch)
  • Qualified air and water systems
  • IQ, OQ, PQ qualified equipment
  • Class 100K and 10K clean rooms




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


  • Large solid- and solution-phase peptide synthesis reactors (up to 500 L)
  • Hybrid synthesis reactor


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


  • Blenders and evaporators
  • Manifold lyophilizers
  • Tray lyophilizers

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




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)

Our CGMP specifications and testing procedures include the following:

  • Appearance: white to off-white solid
  • Solubility: Clear solution at a predefined concentration
  • Purity (HPLC, UPLC): 95-98% specific to phase of development
  • Molecular weight (MS)
  • AAA (Amino Acid Analysis): ±10% of theoretical
  • Peptide content: ≥70%
  • Counter-ion content
  • Moisture content (Karl Fisher): ≤10%
  • Residual Solvent Content: GC-MS
  • Residual trifluoroacetic acid:  ≤0.1%
  • Bioburden: Report Aerobic and Spore Count, USP guidelines
  • Endotoxin: Report LAL (Gel Clot), USP guidelines
  • Elemental Analysis (ICP-MS): Report results for the following metals: Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn

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


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.


CPC Scientific is a full-service peptide CDMO-CRO and provides comprehensive product lifecycle support at every phase.

  • Discovery
  • Preclinical
  • Clinical
  • Commercial



Meet CPC Scientific !

Founded in 2001, CPC Scientific is a global provider of high-quality CGMP and custom peptides to researchers and pharmaceutical companies.

Watch our CGMP video to learn more about CPC Scientific and our manufacturing capabilities.

  • US FDA-inspected facilities (No Form 483 observations)
  • Multiple isolated process and purification suites
  • Flexible reaction vessel sizes (1 L to 500 L)