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GMP Citations from CPC Scientific

GMP Peptide Manufacturing Citation

Multimodal endoscope can quantify wide-field fluorescence detection of Barrett’s neoplasia

To demonstrate the clinical use of a multimodal endoscope with a targeted fluorescently labeled peptide for quantitative detection of Barrett’s neoplasia..

"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."

Joshi, Bishnu P., et al. Endoscopy 48.02 (2016): A1-A13.Learn More »

GMP Peptide Manufacturing Citation

Targeted imaging of esophageal neoplasia with a fluorescently labeled peptide: first-in-human results.

Esophageal adenocarcinoma is rising rapidly in incidence, and usually develops from Barrett’s esophagus, a precursor condition commonly found..

"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..."

Sturm, Matthew B., et al. Science Translational Medicine 5.184 (2013): 184ra61-184ra61.Learn More »

GMP Peptide Manufacturing Citation

TLR4-dependent activation of dendritic cells by an HMGB1-derived peptide adjuvant.

High mobility group box protein 1 (HMGB1) acts as an endogenous danger molecule that is released from necrotic cells and activated macrophages..

"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."

Saenz, Rebecca, et al. J Translational Medicine 12 (2014): 211.Learn More »


GMP Peptide Manufacturing Citation

Candida skin test reagent as a novel adjuvant for a human papillomavirus peptide-based therapeutic vaccine.

A vaccine adjuvant that can effectively promote cell-mediated immunity is currently not available. Because of the ability of a Candida skin test reagent injection..

"...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…"

Wang, Xuelian, et al. Vaccine 31.49 (2013): 5806-5813.Learn More »

GMP Peptide Manufacturing Citation

Hpv e6 protein t cell epitopes and uses thereof.

The present invention is directed to the examination of the pattern of immunodominant T cell epitopes in the E6 protein of Human Papilloma virus..

"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). "

Nakagawa, Mayumi. U.S. Patent Application No. 14/566,604, filed August 13, 2015.Learn More »

GMP Peptide Manufacturing Citation

Recall antigen for promoting T-helper type 1 response.

Provided herein is a method of stimulating a systemic T helper cell type 1 response in a person in need thereof, the method comprising: injecting..

"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."

Nakagawa, Mayumi. U.S. Patent Application 15/552,285, filed February 15, 2018.Learn More »