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.
Like their research-grade counterparts, TheraPEAK® P3 Primary Cell Nucleofector® Solution and TheraPEAK® Nucleofector® Supplement 1 provide a protective environment that allows high transfection efficiency and cell viability, while helping to maintain physiologically relevant cellular functions. They are used in combination with the TheraPEAK® 1 mL Nucleocuvette® Cartridges (coming soon) or TheraPEAK® LV Nucleocuvette® Cartridges and TheraPEAK® Nucleofector® LV Reservoirs.
The compositions of the TheraPEAK® Nucleofector® P3 Solution and Supplement 1 remain unchanged to the corresponding research-grade versions. However, the TheraPEAK® Solutions comprise a higher quality level in terms of used raw materials and production process. Manufacturing and testing takes place according to Eudralex GMP Annex 1.
Specifications of chemical parameters (pH, osmolality, conductivity) for TheraPEAK® Nucleofector® P3 Solution and Supplement 1 are identical to the corresponding research-grade P3 Nucleofector® Solution and Supplement 1 and biological performance was tested to be in the same range.
TheraPEAK® Nucleofector® P3 Solution and Supplement 1 are tested for
- 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)
TheraPEAK® P3 Nucleofector® Solution Sets comprise two components which are mixed together prior to use:
- 1 vial TheraPEAK® P3 Primary Cell Nucleofector® Solution
- 1 vial of TheraPEAK® Supplement 1
The sets are available in two different sizes:
- 22.5 mL and 5 mL
- 126 mL and 28 mL (higher volume size to support upstream sample preparation)
Disclaimer: TheraPEAK® Nucleofector® Products are produced according to applicable GMP standards and are intended to support GMP manufacturing. TheraPEAK® Nucleofector® Solutions are manufactured at a GMP certified site. TheraPEAK® Nucleofector® Products are not intended for in vivo and/or diagnostic purposes.
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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
