CGMP Manufacturing Citations
THE FOLLOWING CITATIONS ARE FOR PEPTIDES MANUFACTURED IN OUR FDA-INSPECTED GMP FACILITY.
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 [..]
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).
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 …
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 [..]”
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.
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..”
Joshi, Bishnu P., et al. Endoscopy 48.02 (2016): A1-A13
"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.”
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 […]
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.”
Wang, Xuelian, et al. Vaccine 31.49 (2013): 5806-5813.
“…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…”
Sturm, Matthew B., et al. Science Translational Medicine 5.184 (2013): 184ra61-184ra61.
“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…”