GMP Peptide Manufacturing Overview
With 25 years of dedicated service to the pharmaceutical industry, CPC Scientific specializes in large-scale, late-phase, and commercial GMP peptide manufacturing. As a leading CDMO with an annual peptide API production capacity of over 1,000 kg and a per-batch peptide production capacity of 20–25 kg, we manufacture synthetic GMP peptides across early-phase development, late-phase development, and full commercial production, providing complete lifecycle support.
Our production facilities adhere rigorously to CGMP guidelines as mandated by major global regulatory authorities, including the NMPA, FDA, EMA, TGA, and MFDS. We have successfully passed FDA inspections five times as of the Latest Practicable Date. Furthermore, our facility holds ISO9001 and ISO13485 certifications for quality management systems.
Late Phase GMP Production Track Record
CGMP Peptide Manufacturing Projects by Region
Our production facilities adhere rigorously to CGMP guidelines as mandated by major global regulatory authorities, including the NMPA, FDA, EMA, TGA, and MFDS. We have successfully passed FDA inspections five times as of the Latest Practicable Date.
Furthermore, our facility holds ISO9001 and ISO13485 certifications for quality management systems.
WHY CHOOSE CPC SCIENTIFIC?
We understand that there are many peptide CDMO choices in today’s market. Learn more about what separates CPC Scientific from other GMP manufacturers.
GMP Peptide Manufacturing Capacity
CPC Scientific has the manufacturing capacity to support your GMP projects at every stage, from early discovery through late-phase development and commercialization. We also have the flexibility, pre-qualified workspace, and robust supply chain to rapidly incorporate new projects into our production pipeline.
US-Based Peptide Manufacturing
Building resilient supply chains will protect the United States from experiencing shortages of critical therapeutic products. CPC Scientific’s Rocklin, CA manufacturing facility will address the critical supply chain needs for peptide APIs beginning in 2026.
Proven Track Record in GMP Peptides
With 25 years of expertise in peptides, CPC Scientific has a proven track record in NCE and API development, bulk-scale manufacturing, and regulatory affairs. We bring extensive experience in both early- and late-phase development, having supported over 100 projects in clinical development and more than a dozen commercial products.
Peptide API Manufacturing Expertise
We have 25 years of peptide manufacturing experience.
SPPS, LPPS, ligation chemistry and fragment condensation methodologies All protecting strategies (Boc, Fmoc, Cbz) may be utilized Innovative purification and isolation techniques employed Process development and scale-up competence ensures a robust commercial process Complex sequences and peptide modifications adapted to large-scale production
Regulatory Support for GMP Peptides
Complete support for your IND and NDA US and international filings.
All required regulatory support for your peptide APIs Phase appropriate control systems consulting Information necessary for chemistry, manufacturing, and controls (CMC) compilation for Investigatory New Drug (IND) and New Drug Application (NDA) submissions Drug Master File (DMF) compilation and submission Annual product reviews
CGMP Manufacturing Compliance
CPC Scientific’s CGMP program strictly adheres to FDA/EU CGMP guidelines.
Code of Federal Regulations Part 210/211 (21 CFR 210/211) ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)
Confidentiality & Confidence
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 Scientific will assure the complete confidentiality of all proprietary information we receive during the course of fulfilling any of our custom services.
Quick Delivery Time of Projects
Delivery time is a critical component of your project’s success. We have the capacity and flexibility to accept new projects and initiate production sooner than many leading peptide manufacturers.
Complete Lifecycle Manufacturing
CPC Scientific stands with you at every stage of development including lifecycle support through the discovery phase, preclinical development, clinical trials, and commercial manufacturing.
COMPLETE LIFECYCLE SUPPORT FOR GMP PEPTIDES
CPC Scientific’s integrated service model is designed to support partners through the most critical phases of GMP peptide drug development, with particular focus on late-phase development, large-scale manufacturing, and commercial production.
GMP Peptide Manufacturing Brochure Request
With 25 years of committed service to the peptide industry, CPC Scientific is a trusted peptide manufacturer of high-quality APIs to pharmaceutical companies and researchers all over the world. We are comprised of peptide experts who have actively pursued peptide design and large scale manufacturing for more than 30 years. Discover how we can support your GMP peptide and oligonucleotide manufacturing needs throughout the therapeutic lifecycle with our comprehensive CRDMO services.
Explore Our Expertise in GMP Peptides
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Latest News on GMP Peptides
CPC Scientific’s recent articles and resources on GMP peptides
Innovative Peptide Manufacturing Methods That Scale
Dive into Joseph Denby's presentation at NextGen Biomed 2026, where he shares a case study on delivering sustainable, efficient peptide manufacturing at scale through our advanced SPPS process optimizations.
Innovative Peptide Manufacturing Methods That Scale
Dive into Joseph Denby's presentation at NextGen Biomed 2026, where he shares a case study on delivering sustainable, efficient peptide manufacturing at scale through our advanced SPPS process optimizations.
GMP Peptide Manufacturing Citations
CPC Scientific peptide products manufactured under CGMP conditions
A Randomized Double-Blind Phase 2 Clinical Trial Treating Cervical Intraepithelial Neoplasia 2/3 with PepCan or Candida
Nakagawa, Mayumi, Teresa Evans, Milan Bimali, Hannah Coleman, Jasmine Crane, Nadia Darwish, Jennifer L. Faulkner et al. MedRxiv (2025): 2025-01.
The vaccine consisted of four current good manufacturing production-grade synthetic peptides covering the HPV 16 E6 protein [amino acid (aa)1-45, 46-80, 81-115, and 116-158] (CPC Scientific, San Jose, CA [..]
Assessment of the Pharmacokinetics, Disposition, and Duration of Action of the Tumour-Targeting Peptide CEND-1.
Järveläinen, Harri A., Christian Schmithals, Maike von Harten, Bianca Kakoschky, Thomas J. Vogl, Stephen Harris, Claire Henson, Gemma Bullen-Clerkson, and Albrecht Piiper. International Journal of Molecular Sciences 24, no. 6 (2023): 5700.
The cyclic iRGD/CEND-1 peptide [sequence: CRGDKGPDC] and RGD control peptide (CRGDDGPKC) for pre-clinical use was sourced either from GenScript (Piscataway, NJ, USA) or CPC Scientific (Hangzhou, China).
An optimized radiosynthesis of [18F]DK222, a PET radiotracer for imaging PD‐L1.
Holt, Daniel P., Dhiraj Kumar, Sridhar Nimmagadda, and Robert F. Dannals. Journal of Labelled Compounds and Radiopharmaceuticals 66, no. 2 (2023): 47-54.
to current Good Manufacturing Practice (cGMP) requirements. In addition, the production is ... -NODA; Figure 1) was custom synthesized from CPC Scientific (San Jose, CA). The authentic ...
Pharmacokinetics and safety of TCMCB07, a melanocortin-4 antagonist peptide in dogs.
Axiak-Bechtel, Sandra M., Stacey B. Leach, David G. Scholten, Jessica R. Newton-Northup, Brendan J. Johnson, H. E. Durham, Kenneth A. Gruber, and Michael F. Callahan. Pharmacology Research & Perspectives 9, no. 3 (2021): e00777.
TCMCB07 [a cyclic substituted melanocortin antagonist with the structure Ac- Nle- cyclo[Asp- Pro- DNal(2’)-Arg- Trp- Lys]- DVal- DPro- NH2] was manufactured by CPC Scientific Inc. under cGMP conditions. Active pharmaceutical ingredient was dissolved in milliQ water at 10 mg ml−1, sterile filtered [..]”
Cetrorelix DMF Submission Announcement
SAN JOSE, CA., June 25, 2020 /CPCNewswire/ — CPC Scientific Inc., a San Jose based CDMO with GMP manufacturing facilities in Hangzhou, is pleased to announce that their drug master file (DMF) for cetrorelix acetate has been submitted to the U.S. Food and Drug Administration and has been issued DMF# 034884. This generic peptide API [...]
We are very excited about the addition of the cetrorelix DMF to our growing generic peptide portfolio. Our multi-kg scale cGMP manufacturing facility for cetrorelix will provide more opportunities for IVF treatments in the medical communities and pathways to new treatments for hormone-sensitive breast and prostate cancers.
Recall antigen for promoting T-helper type 1 response.
Nakagawa, Mayumi. U.S. Patent Application 15/552,285, filed February 15, 2018.
“The PepCan peptide mixture will contain four HPV 16 E6 peptides: E6 1-45 (Ac-MHQKRTAMFQDPQER PRKLPQLCTELQTTIHDIILECVYCKQQLL-NH2..), E6 46-80 (Ac-RREVYDFAFRDLCIV YRDGN PYA VCDKCLKFYSKI-NH2..), E6 81-115 (Ac-SEYRHYCYSLYGTTLEQQYNK PLCDLLIRCINCQK-NH2..), and E6 116-158 (Ac-PLCPEEKQRHLDKKQRFHNIRGRWT GRCMSCCRSSRTRRETQL-NH2..) (U.S. Pat. No. 8,652,482). Commercially produced cGMP-grade peptides (CPC Scientific, San Jose, Calif.) will be examined..”
Hpv e6 protein t cell epitopes and uses thereof.
Nakagawa, Mayumi. U.S. Patent Application No. 14/566,604, filed August 13, 2015.
“To define the minimal and optimal amino acids sequences of the CD8 T-cell epitope, 8-mer, 10-mer, 11-mer, and homologous peptides were synthesized (CPC Scientific, Inc, San Jose, Calif.)... Their safety for human use is ensured, in accordance with FDA requirements...(each peptide to be assessed individually [...]
TLR4-dependent activation of dendritic cells by an HMGB1-derived peptide adjuvant.
Saenz, Rebecca, et al. J Translational Medicine 12 (2014): 211.
“...Hp91 (DPNAPKRPPSAFFLFCSE), Hp121 (SIGDVAKKLGEMWNNTAA), scrambled Hp91 (ASLAPPFPNCFDPKSREF), and OVA-I (SIINFEKL) were all synthesized at GMP facilities by [..] CPC Scientific (San Jose, CA, USA). Peptides were synthesized with an N-terminal biotin, acetyl, or fluorescent tag (Cp488) as indicated in the figure legends. Peptides were routinely synthesized with greater than 95% purity.”