Cytiva_APR21_EarlyProcessDevDecisions - 18

Cell Therapy Manufacturing Tries " Building the Plane While Flying It "

Designing for scalability is paramount, Fachin

highly efficient automated production. "

insists, because high manufacturing costs slow the

Technologies needed by the industry include

adoption of cell therapy products, even when they

those capable of supporting scalable processes,

can boast impressive clinical outcomes. Also, the

informatics applications, and the provision of

timelines between safety trials and pivotal studies

specialized raw materials. Fortunately, technolo-

for cell therapies are drastically shorter than those

gies to serve the industry are beginning to emerge

for biologics.

in response to burgeoning demand, which is due

" A lean, scalable manufacturing scheme

to the industry's rapid growth. For example, as

that can be mapped from early-stage to pivot-

Burger notes, technology companies are increas-

al-stage clinical trials with minimal modification "

ingly focused on automating closed-system cell

offers significant advantages, Fachin explains. It

processing and informatics.

can favor repeatability and controllability (and
therefore easier analysis of clinical data and


correlations with product specifications) as well

Fachin also sees automation as key. He suggests

as financial viability at the commercial stage. " This

that developers will need to switch from manual

is where automation can provide a clear benefit, "

processes if they intend to overcome their

he declares. " It can enable predictable workflows

processing challenges. " The aim of cell therapy

and sourcing requirements and even streamline

manufacturing is to deliver a consistent product

QA/QC. "

starting from an intrinsically variable starting

The paucity of bioprocessing technologies also

material, often from a diseased patient, " he says.
" That is a big task. "
" So far, " he points out, " the cell therapy industry

increases cell therapy manufacturing costs.

has relied on largely manual or at best semiauto-

Moreover, the most of the available bioprocessing

mated processes. " Going forward, however, a real

technologies are intended for trial-scale rather

inflection will be needed in the industry's ability

commercial-scale production.

to deliver the right product for each patient. This

" The commercial cell therapy industry is

inflection, Fachin insists, will occur " only when

indeed early in development, " says Scott

manual processing variability is removed from

R. Burger, MD, principal, Advanced Cell

the equation and when full automation will be in

& Gene Therapy. " [It] tends to use tools developed

place to optimize each manufacturing run " for the

for academic clinical trials, rather than scalable,

requirements posed by individual patients.

18 |


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