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FINIA® Fill and Finish System
Overview Value Key Features Specifications Materials Cell Therapy Technologies

Automate Your Fill and Finish Process for Precision

Cell and gene therapy developers and researchers no longer have to rely on a highly manual and variable process. Now they can finish strong with precise, consistent results for suspension cells and adherent cells.

Take Control

See how to take manual variability out of your fill and finish process.



See How It Works

Automate Your Fill and Finish Process

Finia is a functionally closed benchtop system that automates these fill and finish steps:


MIXING

Maintain batch/cell suspension uniformity


COOLING

Maintain consistent environmental temperatures to support cell health


AIR REMOVAL

Remove air that can compromise your final product during cryopreservation


ALIQUOTING

Help ensure consistency with accurate volumes


SEALING

Help maintain sterility of the final product


DATA MANAGEMENT

Facilitate current Good Manufacturing Practices (cGMP) compliance with electronic data recording and reporting
Note: Finia users must qualify/validate the use of Finia and compliance to GMP within their own manufacturing (or laboratory) environment according to their own standard operating procedures (SOPs)/quality system.

Finia: The First of Its Kind in Automated Fill and Finish

Finia is an automated system that formulates and aliquots fluids, including cell suspensions, to prepare for cryopreservation. It consists of a device, a handheld barcode scanner, a monitor with a touch screen and functionally closed single-use disposable tubing sets.
Finia system

Reduce Variability in Your Fill and Finish Process*

  • Maintain post-thaw viability greater than 90% for cell products from healthy T-cell donors
  • Maintain post-formulation cell viability of greater than 95% of inlet cell viability
  • Maintain uniformity of cell concentrations to within 5%
  • Maintain final product temperature to within 3 ˚C (± 3 ˚C) of the user-defined target
  • Manage Finia with one operator and only 12 minutes of hands-on time per run

*Data on file.



Facilitates current Good Manufacturing Practices (cGMP) compliance

  • User authentication
  • Data capture and reporting
  • Workflow configuration and control

Functionally closed

Gamma-sterilized, single-use disposable sets


Optimizes processes

  • Custom formulations and dosage ranges from the outset
  • Intuitive user interface guides the operator
  • Accurate, consistent final product with less than 5% difference in cell concentration between bags


Note: Finia users must qualify/validate the use of Finia and compliance to GMP within their own manufacturing (or laboratory) environment according to their own standard operating procedures (SOPS)/quality system.
Fill and finish software

Cell Processing Application

Facilitate cGMP compliance with the Cell Processing Application. This stand-alone, server-based software manages the device and procedure data. Procedure data is automatically transmitted between the system and the application while the system is operating. Operators use the application to:
  • Specify processing protocols
  • Configure materials and the device
  • Define users and assign permissions
  • Track tubing sets and materials
  • Record alarms
  • Capture electronic data
  • Generate procedure reports


Users must qualify/validate the use of the Finia system and compliance with GMP within their own manufacturing (or laboratory) environment.

Specifications

Download Full Specifications
Specifications
EQUIPMENT TUBING SET VOLUME SPECIFICATIONS
Surface space required: 0.45 m2 (4.8 ft2)
Minimum clearance: 30 cm (11.8 in) around the perimeter of the device
Weight:
   Device: 66.9 kg (147.5 lb)
   Monitor: 4.4 kg (9.7 lb)
Height: 78.5 cm (30.9 in)
Width: 88.9 cm (35.0 in)
Depth: 49.8 cm (19.6 in)
FINIA 50 Tubing Set:
Quality control bag: 10 mL to 40 mL
Product bag 1: 10 mL to 28 mL
Product bag 2: 0 or 10 mL to 28 mL
Product bag 3: 0 or 10 mL to 28 mL
FINIA 250 Tubing Set:
Quality control bag: 10 mL to 40 mL
Product bag 1: 29 mL to 70 mL
Product bag 2: 0 or 29 mL to 70 mL
Product bag 3: 0 or 29 mL to 70 mL
Volume accuracy: ± 2 mL or ± 10% of the target volume, whichever is greater
Product volume range: 20 mL to 174 mL
Material volume: Product volume plus 6 mL residual volume

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