Cytiva_APR21_EarlyProcessDevDecisions - 34

Cell Therapy Process Development and Validation

Table 3. Summary of regulatory categories and activities required for Phase 1 and 2
Regulatory
category

Safety/Purity

Identity

Strength

Quality

Potency

Source of testing
material

Example
Sterility, USP <71>

Verification

Endotoxon, USP <85>

Verification

Mycoplasma, USP <63>

Verification

Impurity testing

Qualification/Validation

Flow cytometry

Qualification/Validation

Karyotype

Qualification/For information only

STR

Qualification/For information only

PCR methods

Qualification/Validation

Cell counting/viability

Qualification/Validation

Performance test

Qualification/Validation

Proliferation testing

Qualification/Validation

Animal models

Qualification/Validation

Flow cytometry

Qualification/Validation

Compendial

Process development

Process development

Process development

Process development

Most cell therapies still use risky and expensive
open, manual processes. The goal is to move
towards closed and automated equipment in order
to reduce costs and risk, as well as to modernize to
meet regulatory and supply demands.
Review a case study on closing and automating a CAR T process.
Learn more about these topics and hear
answers to attendees' questions.

34 |

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Activity required (Phase I/II)

n

REFERENCES
1.	 Lipsitz YY, Timmins NE, Zandstra PW. Quality cell therapy manufacturing by design. Nat Biotechnol. 2016l34:393-400. doi: 10.1038/
nbt.3525.
2.	 Lipsitz YY, Milligan WD, Fitzpatrick I, et al. A roadmap for cost-ofgoods planning to guide economic production of cell therapy
products. Cytotherapy. 2017;19:1383-1391. doi: 10.1016/j.
jcyt.2017.06.009.


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