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qƯ ¡ - EU-Guideline¿¡ ºÎÇÕÇÏ´Â Good Manufacturing Practice (GMP for active pharmaceutical ingredients) ½Ã¼³¿¡¼ Á¦Á¶µÈ ¼¼°è ÃÖÃÊÀÇ Collagenase - ±âÁ¸ Ÿ»çÀÇ Á¦Ç°º¸´Ù ÀûÀº ¾çÀ¸·Îµµ ¿ì¼öÇÑ activity Á¦°ø qÀû¿ë ½ÇÇè ¹× ÁÖ¹® ¾È³»
*PZ activity according to Wunsch, measured at 25oCSERVA Collagenase NB is not intended for use in humans. Responsibility for use of these enzymes in clinical applications and the methods to isolate, purify, cultivate and transplant cells lies solely with the providing physician/researcher. qCollagenase Qualities Isolation of Various Cell Types Optimal tissue dissociation using collagenase with a balanced ration of other proteolytic activities: Collagenase NB 4 Standard Grade Collagenase NB 4G Proved Grade Collagenase NB 5 Sterile Grade Collagenase NB 6 GMP Grade Mild and effective- Collagenase NB 4 Standard Grade for optimal isolation of a broad variety cells. Function tested- Collagenase NB 4G Proved Grade is especially suitable isolation of adipocytes, fibroblasts, hepatocytes and frog oocytes (protocol is available). Ready to use- Collagenase NB 5 Sterile Grade is produced aseptically according to the European Pharmacopoeia. qProduction Compliant to GMP Good Manufacturing Practice for Cell Isolation Production of cells or tissue engineering for transplantation into humans require quality standards according to GMP-guidelines: Collagenase NB 1 GMP Grade Neutral Protease NB GMP Grade Collagenase NB 6 GMP Grade These enzymes are critical raw materials and thus manufactured in compliance with the EU-Guide to Good Manufacturing Practice ¡°GMP for active pharmaceutical ingredients¡± and with the European Pharmacopoeial requirements for reagents used in cell production.For incoming components inspection according to GMP, Reference Collagenase are offeredby SERVA. All Collagenase NB qualities are manufactured at the pharmaceutical plant of Nordmark Arzneimittel GmbH & Co. KG in Uetersen, Germany, the world largest manufacturer of collagenase. The high quality standards of Collagenase NB production quarantee excellent lot-to-lot consistency. qData sheet Datasheet_CollagenaseNB1_GMP.pdf Datasheet_CollagenaseNB6_GMP.pdf Datasheet_NeutralProteaseNB.pdf Datasheet_NeutralProteaseNB_GMP.pdf qProtocol Protocol_adipocytes_pre_human.pdf Protocol_Cardiomyocyte-isolation_rat.pdf Protocol_Islet-isolation_human_GMP.pdf Protocol_Islet-isolation_humanNB1.pdf Protocol_Islet-isolation_rodent.pdf |