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The role of CDMOs in Cell and Gene Therapy Process Development

nication and collaboration between CGT developers and the CDMO. Transparency is a key factor.
Understanding a CDMO's requirements up front
helps to set clear expectations.
When working with a CDMO, tech transfer is not
just a hand-off - it is the beginning of an ongoing
relationship. It is important to establish a strong,
cooperative rapport with the main contact at the
CDMO and to maintain quality oversight on an

the CGT team choose to bring a process back

ongoing basis to facilitate the smoothest possible

in-house for commercial production.

transmission of knowledge. CGT developers
should plan to engage in the tech transfer process


throughout, to assure both parties are documenting plans and developments in detail.

Working with CDMOs who have expertise in assay

The goal of tech transfer documentation is

development and qualification can assure appro-

to improve the effectiveness, efficiency, quality,

priate specifications are incorporated. Leaning on

and compliance of the biomanufacturing tech

established methods at CDMOs, or transferring

transfer process. A thorough, reliable tech transfer

existing methods for further development and

methodology will go a long way towards assuring

qualification, can also form the basis of small

success both in technical aspects and in building

projects to determine if a particular CDMO is the

the business relationship.

right partner.

Tech transfer documentation serves as a critical

Analytical methods are needed for raw

guide, forming the basis from which standard

material characterization, in-process testing, and

operating procedures (SOPs) are developed. This

quality control (QC) release of final products.

transfer roadmap outlines important parameters

When starting out, it can be difficult to know

of a process and product, including materials

what the CQAs of a drug product will be. CGT

and analytical procedures and critical quality

developers often aim to capture as much data

attributes (CQAs). The more defined the process

as possible about their product during process

specifics, the more effective this document can


be in assuring a smooth transfer of technology.
This documentation will also be critical should

12 |

Identifying the correct method for a measurement is challenging. One option is to adopt best


Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

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