|
|
|
General Information |
 |
|
|
|
| |
|
| |
Through continuous product and process improvements, we help set the industry standard for innovative, quality media products.
We have expanded our line of EX-CELL™ proprietary serum-free formulations and continue to collaborate with the world's leading biopharmaceutical companies in the development of customized media and reagents for their projects. SAFC Biosciences is recognized as the largest supplier of dry powder media (DPM) worldwide and we continue to improve our capabilities to meet demand.
The goal of our media development, optimization and customization process is to help simplify your process and accelerate your progress from discovery through development and to manufacturing.
|
| |
|
| |
back to top |
| |
SAFC Biosciences is registered as a Class 1 Medical Device manufacturer, and as such, is subject to audit and inspection by the Food and Drug Administration (FDA). SAFC Biosciences is also certified to ISO 9001:2000 standards. Every aspect of our quality management system, from product development through production, quality assurance and supplier qualifications, meets the international quality standards outlined in the ISO guidelines. SAFC Biosciences maintains its quality standards consistent with the Quality System Requirements (the new cGMPs), including Design Controls as outlined in 21CFR Part 820.
All SAFC Biosciences' manufacturing facilities welcome customer audits and visits. SAFC Biosciences places great value on these visits, which satisfy our customer's requirements for regulatory oversight of key vendors, and help us understand new developments in the regulatory environment faced by our clients. |
| |
|
| |
back to top |
| |
All large-scale media and salt mixtures are produced in accordance with current Good Manufacturing Practices (cGMPs) and are suitable for manufacturing or research applications.
Chemicals used in the manufacture of cell culture media and salt mixtures conform, where applicable, to the published standards of the United States Pharmacopeia (USP), American Chemical Society (ACS), National Formulary (NF) or Food Chemical Codex (FCC). Chemicals meeting European Pharmacopoeia (EP) specifications are available upon request. Certificates of Analysis to support purity and performance claims are obtained from manufacturers or vendors.
Most of our media formulations contain amino acid and vitamin components that are manufactured via fermentation. None of these components are derived from animal materials. The fermentation medium is mainly comprised of sugars, minerals and salts.
For several amino acids, small quantities of milk casein hydrolysate may be used in the early laboratory seed stages as an essential nitrogen source. Also, milk derivatives are generally used in the industry for cryopreservation of microorganisms. Porcine enzymes from Japan or plant enzymes are used during the digestion process of milk casein. We have confirmed that casein hydrolysates are derived from the milk of dairy cattle from Australia or New Zealand, USDA regulated and approved sources determined to be free of BSE. The milk is obtained from healthy animals and collected under the same conditions as those required for material collected for human consumption. Some cultures also may contain fish meat extract from bonito sourced from Japan.
Each medium manufactured by SAFC Biosciences is according to the original published formulation, accepted modifications or modifications essential to the consistent performance and stability of the product. To address the demands of today's technology, SAFC Biosciences' skilled personnel combine the highest grade raw materials available in state-of-the-art equipment and facilities.
Where no standards or grade designations are given for a specific component, it must meet SAFC Biosciences' specifications and be found suitable for the intended use before incorporation into a finished product.
Our partnership philosophy is not limited to our customer relationships. We also maintain key relationships with our suppliers. At SAFC Biosciences, the supply chain management, quality assurance, technical and purchasing departments work together to ensure the raw materials and manufacturing processes from which they are derived are safe, compliant and available when needed. We hold our suppliers to the same strict standards and accountability that our customers demand of us. |
| |
|
| |
back to top |
| |
SAFC Biosciences currently utilizes classical ball mill and blending techniques, as well as a new technology based on pin milling, in the manufacture of its dry powder media. Completed in June 2005, our newest facility provides dry powder media customers with options for media preparation. Two manufacturing sites for dry powder media support risk management concerns and provide continuously milled dry powder media that is completely comparable in quality to SAFC Biosciences' existing media.
All dry powder media (DPM) and salts are manufactured in environments controlled for relative humidity levels and temperature. Individual processing rooms and packaging areas are designed with pressure differentials to control air flow to prevent cross contamination.
Where appropriate, liquid media are produced using pretested base powder media to ensure total quality assurance and product integrity. Alternatively, other media products are manufactured from first principles. First principles constitute a method whereby components of a medium or salt solution are added individually to Water for Injection (WFI) to prepare a liquid product. It differs from our standard production method in that the biochemicals are not milled before hydration.
All water used in the manufacture of liquid media, balanced salts, reagents and liquid specialty products meets the criteria as specified in the USP and EUP monographs for Water for Injection (WFI). Water produced is monitored on a regularly scheduled basis for endotoxin, bioburden and mycoplasma.
Serum-free, classical and specialty media products are membrane filtered using fully validated, microbe retentive filters with a porosity of 0.2 µm or less. Filter integrity tests are performed before and after filtration using a pressure hold method and bubble point test. All filtered media meet the sterility assurance of 10-3.
Catalog bottled liquid media and reagents are dispensed under aseptic conditions in validated Class 100 filling stations into containers that have been sterilized by validated procedures. |
| |
|
| |
back to top |
| |
|
Liquid media and reagents are typically stored at 15 to 30 C or 2 to 8 C. Dry powder media is stored at 2 to 8 C. Product labels and individual product listings on the website include recommended storage conditions. |
| |
|
| |
back to top |
| |
Liquid medium for cell culture is an enriched biochemical solution that, when properly stored, will provide nutrition for cells in culture many months after the manufacture date. In addition to storage at 2 to 8 C, liquid media should be kept away from light sources.
Energetic, ultraviolet light can create toxic photoproducts from riboflavin, tyrosine and tryptophan, which can destroy cells1. Visible light, even from ordinary fluorescent light fixtures, can also degrade media components or create toxic photoproducts2. Experimental fluorescent light was shown to cause a dramatic decrease in plating efficiency of adherent mammalian cells.3.
|
| |
|
| |
back to top |
| |
|
Although many media and reagents included recommended refrigerator storage conditions at a temperature of 2 to 8 C, SAFC Biosciences ships these products at ambient temperatures. These conditions have been shown to not affect the quality or performance of the products. |
| |
|
| |
back to top |
| |
SAFC Biosciences recognizes that each cell culture project is different. Because of this, we understand the importance of tailoring our products and services to satisfy our customers' unique needs. When your requirements go beyond our catalog offering, contact us.
We welcome the opportunity to discuss our ability to provide you with:
- customized media formulations
- specialized packaging and labeling
- precise quality control testing you require for your application
- volume and delivery options to meet your requirements.
|
| |
|
| |
back to top |
1 Stolen, J. & Wang, R. Proc Natl. Acad. Sci. U.S. Vol. 71, pp. 3961-3965, 1974.
2 Wang, R. Photochem. Photobiol., Vol. 21, pp. 373-375, 1975.
3 Wang, R. In Vitro Vol. 12, No. 1 pp, 19-22, 1974.
|
|
|
|
|
