TheraPEAK^® Nucleofector^® Products
GMP transfection solutions for cell and gene therapy

Helping you to expedite your translational path with the 4D-Nucleofector^® LV Unit we have established GMP grade TheraPEAK^® Nucleofector^® Consumables to support the use of the system in a GMP environment.

TheraPEAK^® Nucleofector^® Consumables deliver the same proven performance as their research-grade counterparts, but are produced under higher quality standards using validated manufacturing and testing methods with proper documentation.

• High quality raw materials
• Produced at GMP or ISO 13485 certified sites
• Manufactured and tested with validated methods
• Accompanied by proper documentation and regulatory expertise

TheraPEAK^® P3 Primary Cell Nucleofector^® Solution Sets

• 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>
• Tested for sterility (Ph.Eur. 2.6.1), endotoxin (Ph.Eur. 2.6.14), absence of RNAse/DNAse/RNA/DNA (validated methods), non-visible particles (Ph.Eur. 2.9.19, Method 1), visible particles (Ph.Eur. 2.9.20), chemical and physical parameters (Ph. Eur methods)
• Double-layer packaging
• Available in two sizes (27.5 mL and 154 mL)

TheraPEAK^® LV Nucleocuvette^® Cartridges (weldable)

• Single-use consumables
• Use of biocompatible material, medical grade (where available)
• Produced at an ISO13485:2016 certified site in a class C environment
• Sterilized by ethylene oxide (validated process)
• Testedfor endotoxin (Ph. Eur. 2.6.14), cytotoxicity (EN ISO 10993-5:2009), visible particles (Ph. Eur. 2.9.20), sub-Visible particles (Ph. Eur. 2.9.19), biology (Nucleofection)
• Double-layer packaging
   

TheraPEAK^® 1 mL Nucleocuvette^® Cartridges – coming soon

TheraPEAK^® 4D-Nucleofector^® LV Reservoir (weldable)

• Single-use consumables
• New design allowing for closed filling from top
• Use of biocompatible material, medical grade (where available)
• Produced at an ISO13485:2016 certified site in a class C environment
• Sterilized by ethylene oxide (validated process)
• Tested for endotoxin (Ph. Eur. 2.6.14), cytotoxicity (EN ISO 10993-5:2009), visible particles (Ph. Eur. 2.9.20), sub-Visible particles (Ph. Eur. 2.9.19), biology (Nucleofection)
• Double-layer packaging

Do you have any questions, need support or would like to discuss your transfection scale up with one of our experts? We are here to support you, contact us.

the next scale in cell and gene therapy... Let's reach it together.

* All TheraPEAK^® Products are produced according to applicable GMP standards and follow the USP/EP guidance for cell and gene therapy raw materials. It is the end user's responsibility to ensure full compliance with local regulations in terms gf safety assessments and effective removal prior to patient exposure. TheraPEAK^® Nucleofector^® Solutions are manufactured at a GMP certified site. TheraPEAK^® Nucleofector^® Cartridges and Reservoirs are produced at manufacturing sites with an ISO13485 certified quality management system. TheraPEAK^® Nucleofector^® Products are not intended for in vivo and/or diagnostic purposes.