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TheraPEAK^® P3 Primary Cell Nucleofector^® Solution Set (126 mL + 28 mL)

Name: TheraPEAK ® P3 Primary Cell Nucleofector ® Solution Set (126 mL + 28 mL)
Brand: Lonza

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TheraPEAK^® P3 Primary Cell Nucleofector^® Solution Set (126 mL + 28 mL)

Catalog #: G4LP3-126000

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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126 mL + 28 mL 22.5 mL + 5 mL

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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.

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

126 mL TheraPEAK^{^®} P3 Nucleofector^{^®} Solution

28 mL TheraPEAK^{^®} Nucleofector^{^®} Supplement 1

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SDS, CoA, and Instructions

Safety Data Sheets (SDS)

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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.

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Educational Material

Brochures, White Papers etc.

Videos

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.

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Non-viral Methods for Ex Vivo Cell and Gene Therapy: Is the Future
Non-viral?

Podcast

Listen in as our experts discuss the types and benefits of non-viral methods for ex vivo cell and gene therapy as well as the readiness of electroporation-based technologies for use in GMP manufacturing.

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