TheraPEAK® P3 Primary Cell Nucleofector® Solution Set (22.5 mL + 5 mL)
TheraPEAK® P3 Primary Cell Nucleofector® Solution Set (22.5 mL + 5 mL)
For use in combination with TheraPEAK® Nucleocuvette® Cartridges, supporting the use of the 4D-Nucleofector® LV Unit in a GMP environment.
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Product Overview
TheraPEAK® Nucleofector® Consumables are aimed to support the use of the 4D-Nucleofector® LV Unit as manufacturing equipment in a GMP manufacturing process for advanced therapeutic medicinal products (ATMPs). In such a process, the 4D-Nucleofector® LV Unit and its consumables may be used for non-viral, electroporation-based genetic modification of primary cells, for example T cells or hematopoietic stem cells.
- Sterility (Ph.Eur. 2.6.1)
- Endotoxin (Ph.Eur. 2.6.14)
- Absence of RNAse/DNAse/RNA/DNA (validated methods)
- Sub-visible particles (Ph.Eur. 2.9.19, Method 1)
- Visible particles (Ph.Eur. 2.9.20)
- Chemical and physical parameters (Ph. Eur. methods)
- 1 vial TheraPEAK® P3 Primary Cell Nucleofector® Solution
- 1 vial of TheraPEAK® Supplement 1
- 22.5 mL and 5 mL
- 126 mL and 28 mL (higher volume size to support upstream sample preparation)
Benefits
- Chemically-defined, human and animal-component free composition
- Identity tested, Ph.Eur. grade raw materials
- Aseptically produced at a GMP certified site in a class A environment
- Filled in crimp-sealed glass vials
- Double-layer packaging supporting the clean room cascade
- Validated manufacturing and testing methods
Applications
- Supporting use of 4D-Nucleofector® LV Unit in GMP manufacturing
Storage and Content
- 22.5 mL TheraPEAK® P3 Nucleofector® Solution
- 5 mL TheraPEAK® Nucleofector® Supplement 1
SDS, CoA, and Instructions
Safety Data Sheets (SDS)
Choose a language to view the SDS.
Certificate of Analysis (CoA)
Please enter Lot Number, including all zeros, located on the product label and please take into account that it is case sensitive.
Educational Material
Brochures, White Papers etc.
Videos
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Large-volume Non-viral Genetic Modification in Cell and Gene Therapy
Discover this white paper and learn how researchers are using the 4D-Nucleofector® LV Unit in cell and gene therapy development and manufacturing.
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4D-Nucleofector® LV Unit for Cell and Gene Therapy Applications – Benefits and How it Works
From this video learn how it works and its benefits for cell and gene therapy manufacturing.