Safeguarding Cell / Gene Therapy Manufacturing

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CellSHIELD® is an IP-protected fully closed family of devices ensuring sterility throughout the cell / gene therapy manufacturing process. The products empower biopharma companies and CDMOs alike to safely and efficiently scale-up manufacturing operations – often eliminating the need for a biosafety cabinet.

CellSHIELD

CellSHIELD™

is changing the game for Cell Therapy manufacturers.

/ 01

Fully closed device enabling all open cell therapy process steps to become closed.

/ 02

Low-cost, disposable device replacing costly biosafety cabinets and Grade A space.

/ 03

Eliminates the need for significant investments to close cell therapy manufacturing processes and (re-)train staff.

/ 04

ONLY Closed System spec’d into the manufacturing of an FDA-approved Cell Therapy today!

14

Years of Experience

25+

Countries

450+

Employees

3000+

Global Customers

Unique Benefits
to Cell /Gene Therapy Manufacturing

/ Fully Closed

Device chamber sealed and isolated from external environment. Fully integrity-tested before shipping.

/ Sterile

Pre-sterilized by validated method.

/ Biocontainment

Prevents release and ingress of extraneous biological agents and microbes.

/ Single-Use or Disposable

No cross-contamination risk.

/ Impermeable

To vapors or disinfectants. Compatible with cleanroom disinfectants via liquids or vhp.

/ Zero Leakage

Clinically-validated.

Applications

Quality Control

Therapy Manufacturing

Input Manufacturing

Discovery & Development

Engineered for Simplicity

CellSHIELD® offers a user-friendly and intuitive experience, requiring minimal training. This streamlines the onboarding process for newly-hired employees, allowing them to quickly adapt and contribute to the workforce.

Syringe unit for cellshield

Product Portfolio

CellSHIELD
Syringe Units

CellSHIELD
Vial Adaptors

CellSHIELD
Sampling Kits

CellSHIELD
Luer Locks

Quality by Design

Fully Closed

Fully encapsulated structure prevents syringe-plunger detachment and contamination; enables the device’s pressure equalisation system.

Fully Contained

After attaching the patient cells / media mixture, CellSHIELD® withdraws the cell mixture into the syringe while simultaneously releasing sterilized air to create equilibrium.

Fully Sterile

Air released to make way for the cell mixture flows through a needle in the syringe center and ultimately passes through a hydrophobic filter.

Multiple Uses

When the media is ultimately released from CellSHIELD®, incoming air passes through the filter to maintain sterility; the filter also allows EtO gas to pass through originally, before any product usage.

Supported by Peer-Reviewed Clinical Studies

Peer-Reviewed
2018
#air-tight

Application of the 2015 proposed NIOSH vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs

University of North Carolina
Peer-Reviewed
2021
#air-tight
#syringe unit
#syringe-contamination

An Assessment of Exposed Syringe Inner Walls as a Route of Exposure from Hazardous Drugs

UNC Eshelman School of Pharmacy
Peer-Reviewed
2015
#Head of Pharmacy
#Pharmacist
#plunger-contamination

Syringe plunger contamination by hazardous drugs: A comparative study

Journal Oncology Pharmacy Practice

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