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4 Pharmaceutical Technology
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BioPharm International
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Trends in Manufacturing May 2025 PharmTech.com
D
espite the tremendous therapeutic prom-
ise of cell and gene therapies (CGTs) for pa-
tients globally, the space is at a crossroads.
Long-standing issues around patient acces-
sibility have contributed to investor pullback, biotech
companies shuttering, and even a few life-saving
therapies being pulled from markets.
The industry needs to do better to support all pa-
tients in need. The biggest obstacle to accessibility
has been pharma's need to effectively reinvent man-
ufacturing for living drugs made from human cells.
It has not been possible to develop large-batch man-
ufacturing as is done for most other therapeutic mo-
dalities, meaning commercial-scale manufacturing
has until now been unrealistic. Finally, the industry
is beginning to incorporate Industr y 4.0 concepts
that have worked well for other types of manufac-
turing, including automation.
Industr y 4.0 is more than just the t ypes of tech-
nology that are deployed. Rather, these approaches
underscore integration across the end-to-end patient
journey. Many biopharmaceutical companies are still
thinking about a black box (or several) to swap in for
specific manufacturing processes, but that won't
enable the kind of scale most therapies will need to
meet total patient demand. Still others are relying on
contract development and manufacturing organiza-
tions (CDMOs) to enable scale through next-genera-
Ushering in Industry 4.0 with
the IDMO Model to Solve the
CGT Manufacturing Bottleneck
John Tomtishen
is senior vice-
president and
general manager
(IDMO Business),
Cellares.
Global scale-up requires developing replicable processes that work
the same no matter where they are performed. This can be accomplished
with smart factories that utilize fully automated manufacturing platforms.
