Catalent eBook - 11

Novel Approaches to Improve Cell Therapy Manufacturing

Manufacturing by Design
generic allogeneic process
For the first roll-out of this approach, a case study with a generic allogeneic process illustrated in figure 3 was
used. The process steps considered are cell acquisition, preparation/selection, activation, electroporation and
transduction, expansion, purification and formulation, fill and finish.

figure 3 Typical process steps in a generic allogeneic T-cell therapy manufacturing process.
cell acquisition

preparation
& selection

Activation

engineering
Viral vector transduction

engineering
Electroporation

+

Fresh vs. frozen
formulation,
fill & finish

release testing

purification

expansion

Patient

Vials

Dynamic system

methodology overview
The MbD methodology was established after a series of internal workshops and similar tools (risk assessments,
process analysis) as found in the QbD methodology. The different steps selected for the MbD methodology are
summarized in figure 4 (below).

figure4 MbD methodology overview

Manufacturing
challenges
definition

Selection of
manufacturing
attributes

Process
analysis

Process
heat map

Critical process
step analysis

Impact
mapping

GENengnews.com

| 11



http://www.GENengnews.com

Catalent eBook

Table of Contents for the Digital Edition of Catalent eBook

Contents
Catalent eBook - 1
Catalent eBook - 2
Catalent eBook - 3
Catalent eBook - Contents
Catalent eBook - 5
Catalent eBook - 6
Catalent eBook - 7
Catalent eBook - 8
Catalent eBook - 9
Catalent eBook - 10
Catalent eBook - 11
Catalent eBook - 12
Catalent eBook - 13
Catalent eBook - 14
Catalent eBook - 15
Catalent eBook - 16
Catalent eBook - 17
Catalent eBook - 18
Catalent eBook - 19
Catalent eBook - 20
Catalent eBook - 21
Catalent eBook - 22
Catalent eBook - 23
Catalent eBook - 24
Catalent eBook - 25
Catalent eBook - 26
Catalent eBook - 27
Catalent eBook - 28
https://www.nxtbookmedia.com