| Production |
The production facility is carefully planned to create an environment for
efficient production and stringent quality control. To promote efficient
production and secure quality, the personnel flow is naturally divided between
production and quality control. Quality control measurements and analysis are
performed in well-defined areas. The microcarriers are manufactured with a
set of well-defined and optimized procedures. In-process controls are
implemented at carefully selected critical stages. Chemicals used in the
production are carefully analyzed for identity, purity and functionality.
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Gelatin |
Gelatin is derived from the connective tissue protein, collagen. Due to its excellent compatibility with human tissue, gelatin is widely used in the pharmaceutical industry. Not only for making capsules but also in wound treating procedures as well as in blood plasma substitutes. Gelatin used for the production of CultiSpher microcarriers is produced in one of Europe's largest facilities. The gelatin used for production of CultiSpher microcarriers is of pharmaceutical quality. This type A porcine gelatin is processed from connective tissue from young healthy animals. Pork skin is acid treated, hot water extracted, purified by ion exchange followed by heat sterilization. Drying and grinding finally yields a product that meets USP requirements with high Bloom strength and low bioburden. CultiSpher microcarriers are produced from selected lots of this purified material
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BSE |
According to U.S. Food and Drug Administration "there does not to appear to a basis for the objection to the use of gelatin produced from porcine skins, from any source country, in FDA-regulated products for human use.", Guidance for Industry: The Sourcing and Processing of gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use, Docket No. 97D-0411, U.S Department of Health and Human Services, Food and Drug Administration, September 1997.
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CoA |
Additional parameters which can be determined at request, such as; virus content and residues of organic solvents.
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Documents |
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Master File |
Percell Biolytica has a Master File for a device at the US Food and Drug Administration, MAF - 1065, CultiSpher, a gelatin microcarrier which is used in vivo. To use this Master File in connection with your registration application, please contact us.
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