Cytiva_APR21_EarlyProcessDevDecisions - 33

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

Agency

Guideline

ICH

Q2(R1) Validation of Analytical Procedures

USP

<1225>: Validation of Compendial Methods

USP

<1226>: Verification of Compendial Methods

USP

<1224>: Transfer of Analytical Procedures

FDA

Analytical Procedures and Method Validation for Drugs and Biologics (2015)

FDA

Bioanalytical Method Validation Guidance for Industry (2018)

Table 2. Key regulatory guidelines for cell therapies marketed in the US

PROCESS ROBUSTNESS

SUMMARY

Process robustness is an important manufactur-

We have described the requirements to get a

ability parameter, to make sure that the process

process ready for manufacturing. And while

will work not only in a perfect research and devel-

manufacturing process validation is not required

opment space but also during the normal repeat-

for an early phase project, it does apply for the

able conditions of manufacturing operations.

analytics in the early phases.

For example, if samples have to be collected and

Tip: It is so important to make decisions when

tested immediately, does that mean lab analysts

designing a process, so that there is a pathway to

have to work 24 hour shifts, when that sample is

guide your decision making throughout the devel-

pulled? The goal is to perform a robustness study

opment life cycle.

and demonstrate stability of the sample on the

Process qualification is always designed and

bench, in a fridge, or in a freezer, until morning

evaluated to determine and reduce variability

when it can be analyzed on a scheduled timetable.

as much as possible, in order to support the end

Tip: Qualification is actually a subset of method

goal of commercial manufacturing. And when

validation, before Phase III. Eventually, these

you've completed all this development work, you

methods will need a full validation, so if early indi-

still monitor and continue to improve the vari-

cations show that there may be issues that would

ability and reduce failure risk during the product

impact a validation, a new strategy may be required.

life cycle and as projects go forward.

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