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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

COMPLETE PRODUCT LIFECYCLE SUPPORT

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

  • Discover
  • Preclinical
  • Clinical
  • Commercial Manufacturing

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.

GMP Peptide Mannufacturing Equipment

Our clean rooms were designed in strict accordance to US-FDA guidelines for GMP Manufacturing. CPC Scientific has passed multiple US-FDA inspections without ever receiving Form 483 observations.

CGMP Manufacturing Citations

"The PepCan peptide mixture will contain four HPV 16 E6 peptides: E6 1-45 (Ac-MHQKRTAMFQDPQER PRKLPQLCTELQTTIHDIILECVYCKQQLL-NH2 (SEQ ID NO:2)), E6 46-80 (Ac-RREVYDFAFRDLCIV YRDGN PYA VCDKCLKFYSKI-NH2 (SEQ ID NO:3)), E6 81-115 (Ac-SEYRHYCYSLYGTTLEQQYNK PLCDLLIRCINCQK-NH2 (SEQ ID NO:4)), and E6 116-158 (Ac-PLCPEEKQRHLDKKQRFHNIRGRWT GRCMSCCRSSRTRRETQL-NH2 (SEQ ID NO:5)) (U.S. Pat. No. 8,652,482). Commercially produced cGMP-grade peptides (CPC Scientific, San Jose, Calif.) will be examined.. CANDIN was dialyzed before use to remove a small amount of solvent (0.4% phenol) using Slide-A-Lyzer G2 Dialysis Cassette (Thermo Scientific, Rockford, Ill.). LCs were prepared as described above, and one million LCs each were treated with CANDIN (150 μl/ml), four current good manufacturing practice-grade HPV16 E6 peptides [E6 1-45, E6 46-80, E6 81-115, and E6 116-158 (referred to as “peptides” hereafter); 10 μg/ml/peptide; made by CPC Scientific, Sunnyvale, Calif."

1. Nakagawa, Mayumi. "RECALL ANTIGEN FOR PROMOTING T-HELPER TYPE 1 RESPONSE." U.S. Patent Application 15/552,285, filed February 15, 2018. Learn More »

"ASY*-FITC was synthesized using good manufacturing practice (GMP) methods (CPC Scientific, Inc.). Stability was evaluated on high-performance liquid chromatography (HPLC) and mass spectrometry. Aliquots of peptide (0.8 mg) were stored at −20 °C as lyophilized powder in single-use amber vials for protection from light."

2. Joshi, Bishnu P., et al. "Multimodal endoscope can quantify wide-field fluorescence detection of Barrett’s neoplasia." Endoscopy 48.02 (2016): A1-A13.Learn More »

"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.). All peptides were dissolved in small amounts of dimethylsulfoxide (˜50 μl), diluted to 5 mM with phosphate buffered saline, and kept frozen at −80° C. until final dilution for their use in the assay... Commercially produced cGMP-grade peptides (90% purity; CPC Scientific, San Jose, Calif.) is examined. Their safety for human use is ensured, in accordance with FDA requirements, by testing 14-day sterility (USP <71>), testing pyrogens, describing appearance and identity, analyzing amino acids, determining impurities by HPLC, assessing H2O content and net active peptide, and describing any organic solvents (each peptide to be assessed individually as per the FDA). "

3. Nakagawa, Mayumi. "Hpv e6 protein t cell epitopes and uses thereof." U.S. Patent Application No. 14/566,604.Learn More »

"The peptides, including 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."

4. Saenz, Rebecca, et al. "TLR4-dependent activation of dendritic cells by an HMGB1-derived peptide adjuvant." J Transl Med 12 (2014): 211.Learn More »

"...four current good manufacturing practice-grade HPV16 E6 peptides [E6 1-45, E6 46-80, E6 81-115, and E6 116-158 (referred to as “peptides” hereafter); 10 μg/ml/peptide; made by CPC Scientific, Sunnyvale, CA…"

5. Wang, Xuelian, et al. "Candida skin test reagent as a novel adjuvant for a human papillomavirus peptide-based therapeutic vaccine." Vaccine 31.49 (2013): 5806-5813.Learn More »

"For the clinical and pharmacology/toxicology studies, ASY*-FITC was GMP synthesized (CPC Scientific). Stability was evaluated by appearance (color), HPLC, and mass spectrometry for 3 years. The pharmacology/toxicology study in rats was conducted in accordance with FDA CFR title 21, part 58..."

6. Sturm, Matthew B., et al. "Targeted imaging of esophageal neoplasia with a fluorescently labeled peptide: first-in-human results." Science Translational Medicine 5.184 (2013): 184ra61-184ra61.Learn More »