4 BioPharm International
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Emerging Therapies eBook September 2024 www.biopharminternational.com
KESTUTIS
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STOCK.ADOBE.COM
O
ver the past two decades, 32 cell and gene
therapies (CGTs) have been approved by
the regulatory authorities worldwide,
and more than 2000 novel products are
under clinical investigation (1). However, many
patients do not have access to these life-saving
therapies, partly due to the complexity and high
cost of manufacture (2). But how can CGTs be made
more cost-efficient given the high labor and facility
costs?
According to Miguel Forte, CEO, of Kiji Therapeu-
tics, France, and president of the International So-
ciet y for Cell & Gene Therapy, "It is clear that CGTs
have the opportunit y to deliver enormous value to
patients; nonetheless, manufacturing is complex,
and it has been challenging to deliver the product.
I n nov at ive te c h nolog ie s a nd s e r v ice s h ave e n-
abled the industr y to move towards an automated,
closed-system approach that is easier and safer to
operate and is less costly and closer to the patient."
Technological advances in manufacturing
Cell therapies can be derived ex vivo f rom autolo-
gous cell therapies (patient to patient), allogenic cell
therapies (donor to patient), or in vivo cell therapies
(cell line to patient). Each approach requires manu-
facturers to tailor the biomanufacturing process to
generate specific cell types (and/or vectors), safely,
efficiently, and cost-effectively. Manufacturing tools
have tended to lag beh ind scient if ic adva nces in
CGTs leading to bottlenecks in cell production. Cur-
rently, most CGT manufacturers use disconnected
single-step/modular or semi-automated solutions;
however, the industry is migrating towards fully au-
tomated cell therapy manufacturing processes (3).
And this approach could significantly reduce man-
ual intervention, risk of contamination, and human
error; improve product quality and speed of delivery;
and reduce production costs (4).
According to David Smith, vice president of Devel-
opment, BioCentriq, "Labor costs, and facility costs
Frontrunners in
Automated Cell and Gene
Therapy Manufacturing
Cheryl Barton, PhD
is director of PharmaVision,
info@pharmavision.co.uk.
Innovative solutions are making personalized
cell and gene therapies accessible to all.
