Closed-system compatibility CTS Xenon Lower Conductivity Electroporation Buffer is available in 100-mL bottle and 100-mL bag formats for convenient process development and closed-system manufacturing scale-up. CTS quality Gibco CTS products follow USP 'ancillary materials for cell, gene, and tissue-engineered products' within the responsibilities applicable to a supplier.* The products are supplied with harmonized documentation such as intended use statements, certificates of analysis, certificates of origin, and convenient access to our drug master file (DMF). Full documentation traceability is available to support your regulatory filing. Gibco CTS products are manufactured at a site that uses methods and controls that conform to cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing sites are ISO 13485-certified. *Other aspects of USP will be the responsibility of the end user to assess. Thermo Fisher Scientific cannot fulfill USP in regard to application and therapy-specific aspects (e.g., residual assessment and removal of the AM).
Caractéristiques techniques
| Marque | Gibco |
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| Réf. B-LABO | BL-RE-088241 |
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| Réf. fabricant | 17962171 |
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| Format | Bottle |
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| À utiliser avec (équipement) | CTS™ Xenon™ Electroporation System |
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| À utiliser avec (application) | Cell and Gene Therapy Research, Development and Manufacturing |
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| Type de produit | Electroporation Buffer |
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| Quantité | 1 Bottle |
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| Conditions d’expédition | Gel packs |
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| Volume (métrique) | 100 mL |
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| Qualité de fabrication | cGMP for Medical Devices, 21 CFR Part 820, and ISO 13485 |
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