CellSHIELD

Safeguarding Cell / Gene Therapy Manufacturing

CellSHIELD

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CellSHIELD® is an IP-protected fully closed device ensuring sterility throughout the cell / gene therapy manufacturing process. The product empowers 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.

/ Zero “Deadleg”

No wastage during sampling… and every single dose is crucial.

/ Low Shear

Device suited for sampling mammalian cells & cell transfer without impacting cell viability.

/ Consistency

High assurance of zero defects at point-of-use.

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.

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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