Catalent eBook - 10

Novel Approaches to Improve Cell Therapy Manufacturing

to the identification of Critical Quality Attribute (CQAs)

quality

manufacturing

followed by the categorization of the Critical Process

QbD - Quality by Design

MbD - Manufacturing by Design

Parameters (CPP), with the final goal being the estab-

TPP - Target Product Profile

TMP - Target Manufacturing Profile

lishment of a design space (figure 1) and its associated

CQA - Critical Quality Attribute

CMfA - Critical Manufacturing
Attribute

control strategy.

CPP - Critical Process Parameters

CMP - Critical Manufacturing
Parameter

QbD provides a solid foundation to improve
process and product understanding but presents two

table 1 QbD vs. MbD

limitations:
1. By definition, QbD is mainly focused on product quality. Other industrial considerations, such as process
efficiency, are less frequently captured through this methodology. An attempt to extend the QbD approach to
process efficiency and manufacturability was done in the A-VAX1 case study in the chapter related to applying
QbD to Live Vaccines. In the proposed approach, Key Process Attributes (KPA) are defined along with the
classical CQA. A typical KPA could be the upstream process yield or the overall process output.
2. This approach is mainly applied to the Drug Substance and less to the Drug Product

Our Approach
From an industrial perspective and taking into consideration the current development status of cell-based products, the need to integrate the aspects of process performance and economics along with an end-to-end vision
of the manufacturing process was identified. Catalent's Cell Therapy team internally developed a rationale-based
methodology to address T-cell manufacturing challenges based on the intended final manufacturing process.
This methodology is called Manufacturing by Design
(MbD) and uses a similar approach as QbD for its
implementation. table 1 shows the terminology compar-

f igure 2 Focus areas of MbD

ison of the two approaches.

economics

As previously mentioned, and as illustrated by figure 1,

Cost of goods
Business continuity

MbD is intended to optimize:
process efficiency such as process robustness, process
scalability and operability, supported by the definition of
Critical Manufacturing Attribute (CMfAs)

others
Regulatory
friendliness
Intellectual
property

manufacturing
by design

end-to-end vision from the starting material up to the
final Drug Product including supply chain management

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Scalability
Operability
Robustness

economics with Cost of Goods (CoGs) and business
continuity

process
efficiency

end-to-end vision
Drug substance & drug product
Analytical strategy
Raw material & supply



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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
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