Cytiva_APR21_EarlyProcessDevDecisions - 14

The role of CDMOs in Cell and Gene Therapy Process Development

identify options that will be suitable to regulators

(DoE) approaches and the use of liquid handling

and clinicians.

robotics to allow thousands of formulations to be

Challenges remain with manufacturing

tested in parallel. This capability will drive both a

reagents and consumables suitable for CGT devel-

more complete understanding of the underlying

opment. Smaller volume reagents are typically

biology of CGTs and a reduction in the cost

not provided in closed formats. And consumables

of goods.

are often hand-assembled, which can lead to
manufacturing inconsistency and failures. Though

CLINICAL AND LOGISTICAL CONSIDERATIONS

most culture media still come in bottles, bags with

For CGTs, the activities at a manufacturing facility

weldable lines are now becoming more common.

form the central component of the " vein-to-vein "

On the front end, acquiring
the input cell material often
depends on processes outside
of the manufacturer's direct
control. These processes can
include obtaining autologous
cell material, such as apheresis
units, from collection sites.
Despite the wider availability of ADCF

process. CGT developers must align manufacturing
decisions with clinical and logistical constraints.
On the front end, acquiring the input cell
material often depends on processes outside
of the manufacturer's direct control. These
processes can include obtaining autologous cell
material, such as apheresis units, from collection
sites. Scheduling and sophistication can vary
between sites. Similarly, handling the manufactured CGTs at clinical sites is both challenging

reagents, off-the-shelf reagents might not always

to standardize and subject to variability of both

support specific cell populations of interest in a

process and analytics.

cost-efficient manner. This could motivate the

CDMOs have experience interfacing with

development of custom media formulation. While

these sites and identifying solutions to minimize

several vendors offer custom media services,

risks. Typically, manufacturers aim to formulate

they often rely on conventional formulation

CGTs to minimize point-of-care (PoC) manipu-

techniques which typically lead, at best, to incre-

lations. This might include selecting a cryopro-

mental improvements on current formulations.

tectant that is safe for direct infusion to avoid the

Novel methods for media formulation involve

need for wash or dilution steps. Another example

the use of metabolomics- and proteomics-based

is developing processes that use automated cell

discovery combined with design-of-experiments

thawing systems.

14 |

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Cytiva_APR21_EarlyProcessDevDecisions

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