ST. LOUIS, Oct 26, 2011 /PRNewswire/ -- Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that its custom manufacturing and services business unit, SAFC® (www.safcglobal.com), has completed an assessment by SafeBridge® Consultants, Inc. and has been granted SafeBridge Certification for its commercial scale High-Potency Active Pharmaceutical Ingredients (HPAPI) facility in Verona, Wisconsin. As a widely accepted industry benchmark for handling highly potent pharmaceuticals, the SafeBridge program assessment focuses on four primary areas: management; hazard identification and evaluation; hazard controls; and communication, education and training.
Constructed at a cost of $30 million and officially opened in April 2010, the Verona site was built specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs. The state-of-the-art facility is designed to increase efficiencies and safe handling in high-potency production and to adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The SafeBridge assessment, which also included a successful recertification of SAFC’s nearby Madison, Wisconsin high-potency facility, took place over three days in September, 2011. The process included review of health and safety programs, containment equipment testing results, as well as appraisal of material handling and GMP production areas.
“The latest SafeBridge Certification status for our Verona facility builds on successful accreditations at our Madison HPAPI plant, which we originally received in 2003, and our HPAPI bioconjugation suite in St. Louis, which was awarded in 2009,” commented Dave Bormett, SAFC Director of Operations. “SafeBridge Certification reflects SAFC’s ongoing commitment to the safety of our staff, and to handle our customers’ potent compound projects safely and efficiently.”
Over the last three years, SAFC has seen a continual increase in the number of projects for HPAPIs and other high-potency pharmaceutical services, including late stage projects that will need commercial scale manufacturing. This demand is behind the construction of the Verona facility, which houses commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 liters and features specially designed quality control laboratories, warehouse and office space, including space for expansion.
While oncology is currently the main driver for HPAPI development, SAFC has manufactured HPAPIs for indications beyond the cancer field, including low-dose Vitamin D analogs for the therapeutic areas of autoimmune and cardiovascular diseases. This range of indications may continue to grow as additional potent compounds are identified and developed in future years.
For more information, visit: www.safcglobal.com
The foregoing release contains forward-looking statements that can be identified by terminology such as “may”, “should”, “designed to”, “believe” or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived there from. You should not place undue reliance on these statements. There can be no guarantee that the products described in this release will continue to meet the demands of the marketplace. Nor can there be any guarantee that any of these products will achieve any particular levels of revenue in the future. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management’s expectations regarding these products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the Company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Company’s assets and liabilities as recorded in its consolidated balance sheet, and other risks and factors referred to in Sigma-Aldrich’s current Form 10-K on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sigma-Aldrich is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About SAFC®: SAFC is the custom manufacturing and services business unit of Sigma-Aldrich Corporation. We are recognized as a top 10 global fine chemical supplier and trusted manufacturer of specialty chemicals and biologics for the life science and high technology industries. Utilizing global “Centers of Excellence” and dedicated manufacturing facilities, SAFC can often resolve development and manufacturing challenges and accelerate the production of custom materials. Our rich portfolio includes high-purity inorganic materials for high technology applications, cell culture products, services for biopharmaceutical manufacturing and biochemical production, and complex, multi-step organic synthesis of APIs and key intermediates. For more information about SAFC, visit www.safcglobal.com.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 40 countries and has 8,300 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Innovation and Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning web site at www.sigma-aldrich.com.
SAFC and Sigma-Aldrich are registered trademarks of Sigma-Aldrich Co. LLC. SafeBridge is a registered trademark of SafeBridge Consultants, Inc.
SOURCE Sigma-Aldrich
