CPC Scientific Announces Its Peptide Facility Passes 2nd Successful FDA Inspection

Sunnyvale, CA, February 27, 2012 --(PR.com)-- CPC Scientific is pleased to announce that its 50,000 sf cGMP peptide facility has successfully passed a second US Food and Drug Administration (FDA) inspection. It involved the investigator inspecting CPC Scientific’s peptide production facilities, manufacturing processes, laboratory control and quality systems in Hangzhou, China over four days. There were no Form 483 observations pursuant to FDA regulations CFR 210/211 and ICH Q7A. The FDA assesses whether a peptide API can be manufactured at the company’s peptide production facilities using technology recognized in the US as state-of-the-art and in compliance with all applicable cGMP rules.

"The latest successful FDA audit validates the ongoing investments we have made in our people, our cGMP systems, our research, and to our continual process improvement. We have a smart team that understands the complex dynamics of peptide products, from making the peptides, optimizing the peptides, performing process improvements, and scaling up," said Shawn Lee, President & CEO of the 10 year old company. "Our US customers and those world-wide can depend on the fact that their peptide APIs are made at a reliable company."

About CPC Scientific
CPC (www.CPCScientific.com) is a world leader in the industrial/commercial-scale manufacture of proprietary and generic GMP, non-GMP peptides and medical devices, serving customers of the pharmaceutical, biotech, diagnostic and cosmetic industries. CPC is committed to the highest quality of peptide manufacturing, irrespective of whether this is for approved drug substances, GMP peptides in clinical trials, or small-scale non-GMP peptide custom synthesis, no matter the complexity. CPC possesses state-of-the-art equipment and extensive experience in manufacturing a large variety of peptides at all scales by Solid Phase, Liquid Phase and Hybrid Strategy peptide synthesis.

Our team of experts designs the most efficient processes for peptidic active pharmaceutical ingredients using innovative technologies such as PEGylation, lipidation, glycosylation, ligation, cyclization (multiple disulfide or lactam bridges). Our synthesis of short peptides without HPLC purification allow cost effective processes by reducing the number of chemical steps and increasing yields.

CPC Scientific is also certified by the SFDA, TUV (ISO9001 and ISO13485) and other compliance at the manufacturing site.

Contact Information:
Dr. Shawn Lee, President & CEO, CPC Scientific, Inc.
Tel: 408-734-3800, sales@cpcscientific.com

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