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The role of CDMOs in Cell and Gene Therapy Process Development

of-concept and preclinical studies. Turning this

not compatible with target scales. For example,

process into one that will be robust and cost-ef-

a suspension-based solution might be better for

ficient enough requires a strategic approach to

commercial production where an existing labora-

scaling with diligent planning and proper docu-

tory process uses adherent cell types.

mentation. Experienced experts can guide the
process to avoid the pitfalls and prevent delays in


time to market.
CDMOs have access to, and experience with,

Analytical methods are needed for raw material

varied solutions that allow companies to evaluate

characterization, in-process testing, and quality

different platforms and assess different technolo-

control (QC) release of final products. When

gies for process development (PD). Working with

starting out, it can be difficult to know what

a CDMO at this stage can help alleviate capital

the critical quality attributes (CQAs) of the drug

costs and training burden of performing these PD

product will be. So CGT developers often aim

studies in house.

to capture as much data as possible about their

Process changes between clinical trial phases

product during process development. Identi-

are costly and time consuming to develop. For

fying the correct method for a measurement is a

CGT developers, outsourcing the engineering

challenge, and one option for the field is to adopt

aspects of process optimization can save time. At

some of the best practices from design controls

each development stage, equipment, methods,

used in the development of medical devices and

and materials might require process optimization

in vitro diagnostics. These include defining design

or recreation. Also, changes can result in process

inputs of a method by building a user require-

variability. CDMOs can oversee the alignment of

ments specification for each analytic, so that the

changes with aggressive clinical programs and

assay chosen is truly fit for purpose. Examples of

assure process variability is understood.

specifications to consider are sensitivity, spec-

CDMOs can also help identify the biggest

ificity, turn-around time, cost per test, and the

value-add process modifications and recommend

robustness and ruggedness of the assay. Working

a step-wise program for development, optimi-

with CDMOs who have expertise in assay devel-

zation, and comparability studies. One point to

opment and qualification can guide the choice of

consider is understanding where the greatest

the appropriate specifications. Leaning on estab-

sources of risk or variability are in the current

lished methods at CDMOs, or transferring existing

process; another is changing process steps that are

methods for further development and qualifica-

10 |


Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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