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Non-Animal Origin Components |
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Biochemical Manufacturing |
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The
proper handling and flow of materials are critical to our process. Accordingly,
our St. Louis, USA and Irvine, Scotland facilities were designed to minimize
or eliminate the introduction of normal environmental contaminants into clean
areas and to prevent cross contamination between different product types. For
example, materials of animal and non-animal origin are handled in self-contained
segregated areas.
The facilities are designed to manufacture bulk sterile-filled
liquids in separate buildings, built exclusively for animal free processing.
Along with
associated warehouse, processing controls and cleaning procedures, the manufacturing
zone is completely segregated from any possible sources of animal-derived
materials.
Our commitment to the development of animal-free products has entailed
re-evaluating the identity and source of all raw materials used. Additionally,
plant derived
or recombinant forms of essential growth factors and hormones have been identified.
This has also required the development of synthetic alternatives for such
components as cholesterol and lipids and the development of substitutes for
iron transport and lipid delivery systems. These efforts have lead to the
development of animal component-free media wherein all components can be
documented via a Certificate of Origin, to be isolated from non-animal sources
or synthesized using non-animal starting and processing materials.
SyntheChol™, SAFC's exclusive synthetic non-animal cholesterol supplement
developed for use in serum-free, chemically defined media formulations for
cholesterol dependent production cell lines, is an example of our focused
on the develop of non-animal alternative materials. Critical non-animal
components also include our Polysorbates 20R and 80R. SAFC's non-animal
Tweens utilize non-animal materials and processed in an non-animal environment.
SAFC is also proud to introduce TrypZean™ the first recombinant,
animal-free trypsin expressed in corn. The biological activity of TrypZean™
is comparable to the animal sourced alternative. |
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SAFC's expertise in organic synthesis is position to create many non-animal alternatives for use
in your drug development chain |
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SAFC continues to lead the industry in the development of recombinant alternatives from plant systems |
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Our manufacturing facilities segregate animal origin from non-animal origin materials and processes. |
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Minimizes costs associated with costly viral removal validation studies |
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Accelerate regulatory approval by eliminating the risk of TSE's and other adventitious agents in your upstream processes |
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Being a primary manufacturer, we can assist in your customized product requirements |
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Cell Culture cGMP Manufacturing & Quality Systems (661Kb) |
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