Business Editors & Health/Medical Writers
ST. LOUIS--(BUSINESS WIRE)--Nov. 14, 2002
Sigma-Aldrich Fine Chemicals, a division of Sigma-Aldrich Corporation (NASDAQ:SIAL), has announced that it has developed and will manufacture and distribute SyntheChol(TM), an animal-component free, synthetic cholesterol for use in cell culture and drug delivery applications.
Sigma-Aldrich, well known for its expertise in the formulation of serum-free and protein-free cell culture media, and its large-scale production and processing of bio-organic molecules, made a sizeable commitment to the development and manufacture of SyntheChol. This synthetic cholesterol was developed to address the ever increasing safety and regulatory requirements for raw materials used in the manufacture of biopharmaceuticals or delivery of drugs.
Sigma-Aldrich is the sole manufacturer of SyntheChol. Its development is prominent demonstration of Sigma-Aldrich's tremendous development and manufacturing capability. SyntheChol is just another example of the Sigma-Aldrich commitment to provide the most advanced non-animal alternatives for biopharmaceutical production applications.
"We see the development of a SyntheChol as a major advancement in the formulation of animal-component free cell culture production media and for use in drug delivery systems (e.g. liposomes)," remarks Tom Gelineau, Sigma-Aldrich's Director of U.S. Sales. "We expect the full scale production process to be completed before year end."
Last month, Sigma-Aldrich announced the signing of a manufacturing and distribution agreement with ProdiGene for non-animal recombinant Trypsin called TrypZean(TM) in a continuing effort to develop safer alternatives to animal components used in pharmaceutical applications.
Cholesterol is the principal naturally-occurring sterol of higher animals and is found in all body tissues, especially in the brain, spinal cord and in animal fats and oils. At present, cholesterol is isolated and manufactured commercially from wool grease (lanolin). Cholesterol has found a wide variety of applications in products ranging from pharmaceuticals, cell culture media, cosmetics to food. With increasing concern about brain-related diseases in cattle and sheep, and the possibility that these diseases may be transferred to humans, there is considerable commercial interest in cholesterol from non-animal sources, particularly in the pharmaceutical industry where it would find application in drug delivery systems (e.g. liposomes and emulsifiers), and animal-component free cell culture media.
Recent European regulatory requirements stress the importance of justifying the use of bovine, caprine or ovine origin materials in the production of pharmaceutical products. Although fetal bovine serum has been used for many years in the production process of many medicinal products such as viral vaccines and recombinant DNA products, there is a justifiable trend to remove all material of animal origin from these manufacturing processes. Sigma-Aldrich has recognized this growing trend and works closely with customers to optimize animal free media formulations to meet each customer's cell culture requirements. The FDA, in its role of regulating all medicinal products for human use, has similar guidelines when accepting regulatory submissions.
Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and chemical manufacturing. We have customers in life science companies, university and government institutions, hospitals and in industry. Sigma-Aldrich operates in 34 countries and has over 6,000 employees providing excellent service worldwide. We are committed to the success of our Customers, Employees and Shareholders through leadership in Life Science, High Technology and Service.
This release contains forward-looking statements relating to initiatives, similar intentions and beliefs and other statements regarding the Company's expectations, goals, beliefs, intentions and the like, which involve assumptions regarding Company operations and conditions in the markets the Company serves. The Company does not undertake any obligation to update these forward-looking statements.
For more information about Sigma-Aldrich, please visit us online at sigma-aldrich.com.
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