Navigation Links
SAFC Pharma's St. Louis HPAPI Conjugates Facility Receives SafeBridge Certification
Date:6/1/2009

ST. LOUIS, June 1 /PRNewswire-FirstCall/ -- SAFC Pharma(R) (www.safcpharma.com), a business segment of SAFC(R), a member of the Sigma-Aldrich(R) Group (Nasdaq: SIAL), today announced the certification of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, by SafeBridge(R) Consultants, Inc. for the safe handling of potent drug substances. The suite, located on the company's St. Louis, Missouri campus was designed to support the entire drug development pipeline, from early-stage clinical supplies to kilogram quantities, and expandable to commercial-scale.

The 600 square ft HPAPI suite, commissioned in September 2008, enables the conjugation of Highly Potent Active Pharmaceutical Ingredients (www.safcpharma.com/hpapi) to a variety of targeted delivery molecules known as antibody drug conjugates (ADCs).

"Gaining SafeBridge certification status for our HPAPI conjugation suite provides our customers with complete confidence in our ability to handle their potent compound projects safely and efficiently," commented David Feldker, SAFC Pharma Vice President. "This adds to our already significant experience in the production of HPAPIs, an area in which we continue to see rapid growth as targeted oncology evolves. The suite builds upon 15 years of HPAPI manufacturing experience at SAFC's Madison, Wisconsin site, which is also SafeBridge certified, and upon more than 30 years of experience in conjugation technology at the St. Louis facility."

The SafeBridge program assessment, recognized as the most widely accepted industry benchmark for handling highly potent pharmaceuticals, focuses on four primary areas: (1) management, (2) hazard identification and evaluation, (3) hazard controls, and (4) communication, education and training.

The new SafeBridge certification of the St. Louis HPAPI suite adds to SAFC investments totaling $75 million during the past 18 months to expand its HPAPI capacity. Those include a $4.5 million project to add a cGMP pilot plant and kilo-lab capacity at the Madison facility, completed in early 2008; a $29 million investment to expand bacterial and fungal fermentation derived HPAPI capacity at Jerusalem, Israel, due for completion in early 2010; and a $30 million investment to build a new commercial-scale HPAPI facility at Madison, due to be completed by year-end 2009.

About SAFC: SAFC(R) is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four business segments - SAFC Pharma(R), SAFC Supply Solutions(R), SAFC Biosciences(R), and SAFC Hitech(R)- and had annual sales of over $600 million in 2008. SAFC is considered a top 10 fine chemical company. For more information about SAFC, visit www.safcglobal.com.

About SAFC Pharma(R): SAFC Pharma is a complete pipeline partner for the development and cGMP custom manufacturing of complex small-molecule APIs and biologic drug products. It combines world-class project management and chemistry support for all stages of the drug discovery and development process from research and discovery, through pre-clinical and clinical development to commercialization, with a focus on reducing the drug development time-line. SAFC has the widest range of raw materials, highly qualified and experienced staff, state-of-the-art facilities and an integrated portfolio of services, including full analytical and regulatory support and is a leader in emerging technologies, including high-potency APIs, solid-state chemistry, viral products and chemical-biologic API conjugates. For more information visit www.safcpharma.com.

About Sigma-Aldrich(R): Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic 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 38 countries and has 7,800 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 http://www.sigma-aldrich.com.

SAFC(R), SAFC Pharma(R) , SAFC Hitech(R) and Sigma-Aldrich(R) are registered trademarks of Sigma Biotechnology L.P. and Sigma-Aldrich Co.

SafeBridge(R) is a registered trademark of SafeBridge Consultants Inc.


'/>"/>
SOURCE Sigma-Aldrich Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Pharmasset to Present at Deutsche Bank Healthcare Conference
2. Pharmasset to Present at Two Upcoming Investor Conferences
3. Pharmasset to Present at Two Upcoming Investor Conferences
4. ePharmaSolutions Adds Several Industry Clinicians to its Rater Certification and Data Monitoring Department
5. Pharmasset to Present at the 27th Annual JPMorgan Healthcare Conference
6. Parkland Health & Hospital System Rolls Out Innovations PharmASSIST Technology Platform Across Nine Pharmacy Sites
7. PharmaSmart International, Inc. Redefines Blood Pressure Management through Technology and Pharmacy Focused Patient Services
8. Pharmasset to Webcast an Investor Event from the AASLD Meeting
9. Pharmasset Reports Financial Results for Quarter Ended March 31, 2008
10. Pharmasset to Present at the Rodman & Renshaw Healthcare Conference on Tuesday, May 20th
11. Pharmasset Appoints Patrick T. Higgins as Executive Vice President, Marketing & Sales
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... 28, 2017 , ... Accreditation Commission for Health Care (ACHC) ... America (HCAOA). This agreement allows HCAOA members to receive special pricing on ACHC’s ... Accreditation University (AU) educational resources that help prepare HCAOA members for ACHC Accreditation. ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... Getting enough sleep affects much more than ... (NSF), going just 19 hours without sleep can compromise motor reaction time, which can increase ... and Amica Insurance is sharing the following tips from the NSF to help you sleep ...
(Date:4/28/2017)... ... April 28, 2017 , ... Datta Endoscopic Back Surgery ... the revolutionary endoscopic practice under Dr. Datta. Patel is a Board Certified Anesthesiologist, ... patented, revolutionary eDiscSculpt Technique created and used by Datta Endoscopic is unlike traditional ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... People are ... older people. “Wearing a hearing aid doesn’t have the stigma it had when great-grandpa ... Hearing Associates of Greater Boston, in a NALA North American Speaker Series ...
(Date:4/28/2017)... ... April 28, 2017 , ... Intellitec Solutions ... Grove Foundation implement a Microsoft Dynamics GP solution that integrates to their PointClickCare ... that specializes in long-term care, Brooke Grove now has the capability to achieve ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... Calif. , April 19, 2017  IRIDEX Corporation ... will release financial results for the first quarter 2017 ... 2017.  The Company,s management team will host a corresponding ... p.m. ET. Investors interested in listening to ... 707-0665 for domestic callers or (703) 326-3030 for international ...
(Date:4/19/2017)... NEW YORK , April 19, 2017 /PRNewswire/ ... This report on the prostate cancer ... of the global market. Increasing prevalence of prostate ... as innovation in the development of new drugs ... hormone-refractory prostate cancer drug due to lesser side ...
(Date:4/19/2017)... India , April 19, 2017 ... and Application, Forecast to 2022 report has covered and analysed ... statistics and information on market size, shares and growth factors. ... major drivers, challenges and opportunities in the global market. ... Browse 152 Tables and Figures, ...
Breaking Medicine Technology: