PHCbi-Panasonic eBook - 20

Cell Therapy Today * New Developments in Immunotherapy * The Cleanroom Alternative to CAR T-Cell Therapy and Regenerative Medicine Facilities

a closed-loop, aseptic environment where cells
are isolated from one patient to another.
Regardless, the nature of regenerative medicine
demands careful redeployment or the upgrading
of basic support systems such as cell culture
incubators, centrifuges, ultra-low temperature
freezers, biological safety cabinets, medical
storage refrigerators and other products fundamental to the cell culture equation. This type of
cellular engineering requires a level of reproducibility that is unprecedented in laboratory
medicine. From controlled temperature storage of
media, reagents and other materials used in the
CAR, T process, through incubation, biopreservation, and recovery of engineered cells, the highest
standards for reliability, reproducibility, and accuracy are in demand.
CAR T-cell therapy and related research and
clinical treatments require a highly stable,
contamination-free environment throughout all
phases of the process. This environment is typically created within a conventional cleanroom
where Class 10,000 air quality is compliant with
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| GENengnews.com

cGMP manufacturing and processing whereby all
laboratory equipment essential to these processes
is located inside the cleanroom.
The cell processing work station consolidates
these components into a single space-saving
ubiquitous piece of equipment. It offers a seamless
transition from cell culture research and investigation to clinical trials and direct patient therapies.

Overcoming the Economic Challenge
Cleanrooms are expensive. Their initial costs,
facility space requirements, operating costs, and
maintenance allowances are prohibitive in situations where clinicians and researchers want
to explore the promises of cell therapy or laboratories that do not have the volume to satisfy
a conventional return on investment model.
While it is possible to delegate these protocols
to contract research manufacturers (CRMs) with
existing cleanroom capacity, researchers must
trade-off cGMP compliance with the loss of
direct process control to third parties geographically removed from the core work.

Successful clinical outcomes associated with CAR
T cell, regenerative, stem cell, and a myriad of
other emerging sciences will increase demand for
cGMP space throughout the medical community.
Thus, the need for a self-contained alternative
to the conventional cleanroom has led to the
development of a cell processing work station
that provides a Class 100 environment to meet
cGMP requirements as well as to satisfy economic
models of small to emerging growth enterprises
in the private and public sectors.
Instead of relying on a singular cleanroom service
center within or outside the facility, the cell
processing work station offers a fully distributed
model that includes one or more work stations
located adjacent to both research and patient
care areas.

Benefits of the Cell Processing Work
Station Offer Clear Advantages Over
a Cleanroom
1. The work station is self-contained, relatively
portable, and can be placed in existing labora-


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PHCbi-Panasonic eBook

Table of Contents for the Digital Edition of PHCbi-Panasonic eBook

Contents
PHCbi-Panasonic eBook - 1
PHCbi-Panasonic eBook - 2
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PHCbi-Panasonic eBook - Contents
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