(12PressRelease.com) Menlo Park, CA: C S Bio is proud to announce the opening of their new state of the art Kilo Production Laboratory. C S Bio has been producing high quality custom peptides, cGMP peptides and API peptides for well over 15 years. Whether you need to synthesize peptides for research (5 mg), for industry (kilo) or on a manufacturing scale (multi-kilo), C S Bio can meet your needs. With our years of peptide production experience C S Bio has the knowledge and expertise to assist you with all facets of your peptide project.
Since 1993, C S Bio has been providing custom peptides, cGMP peptides and peptide API‘s to universities, start-ups, research organizations and major pharmaceutical companies worldwide. Our quality control team can assist you with any regulatory issues and out highly skilled team of chemists are outstanding at solving complex peptide chemistry issues such as poor solubility, low yields and peptide racemization. C S Bio features a full service FDA inspected GMP peptide production facility with a primary focus on custom and GMP peptide production. Our goal is to provide our customers with the highest quality compounds available, in a time frame that matches customer requirements. Our staff is highly skilled and has extensive training in both peptide chemistry and Current Good Manufacturing Practices. Ongoing training in cGMPs is conducted throughout the year and documented by our Quality Assurance department.
Three segregated, full service cGMP suites have been designed and built for cGMP peptide production. Each suite contains a synthesis, cleavage and purification lab with proper product flow and air handling. All labs are routinely tested by an independent third party for bio growth and particulate matter. This facility has been issued a Drug Manufacturing License by the State of California Department of Health Services, Food and Drug Branch. A general FDA Inspection was performed in 2007 which resulted in two minor violations. Copies of both the Drug Manufacturing License and the FDA inspection report are available upon request.
In order to establish baseline specifications for purity, single impurities, residual solvent content, moisture content and other parameters that are critical to test during cGMP production, we always encourage an R&D, non-cGMP production run so the peptide can be tested and specifications set prior to cGMP production. This not only helps set Quality Control specifications, it serves as a trial run for the upcoming production of the clinical grade material as well.
C S Bio has a long standing commitment to providing the scientific community with high quality, well characterized synthetic peptides. Our commitment to quality and compliance is a driving force behind our operations. We welcome all current and prospective customers to conduct audits and inspections of our cGMP facilities and systems. Should you have any questions regarding C S Bio‘s synthetic cGMP operations, please do not hesitate to contact me.
More Further Information http://www.Csbio.com
