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Novel Approaches to Improve Cell Therapy Manufacturing

Based on this mapping, the decision was made to focus on the following topics to strengthen the allogeneic
process platform:
* Formulation, Fill and Finish steps

* Processability and manufacturing strategy

* Cell expansion and purification steps

* Raw material strategy

These select topics of industrialization initiative will be further developed in future publications.

Conclusion & Analysis
Capitalizing on the well-established QbD methodology, Catalent's Cell Therapy team has developed a complementary methodology - MbD- to address challenges linked to the industrialization of cell-based manufacturing
processes. This methodology was applied to a generic allogeneic T-cell-based process enabling us to rationally
select the most critical aspects of industrialization in order to propose a robust, scalable, cost-effective and
sustainable allogeneic platform.
One of the key learnings from this exercise was the criticality of the fill and finish operations for allogeneic
products. Catalent offers a significant number of allogeneic projects with the intent to offer our customers a
state-of-the-art filling platform, that accounts for the specificity of allogeneic products.
In order to strengthen and speed-up the development of this commercial allogeneic process platform,
Catalent is looking to establishing collaborations with external service providers to develop and integrate
advanced technology that will provide solutions for today's cell therapy manufacturing challenges.
In conclusion, the same MbD methodology described in this study can be adapted to autologous manufacturing processes and analytical testing systems to provide an assessment platform for next-generation
manufacturing. n

Additional Content: Manufacturing Autologous Therapies
Hear f rom an expert panel featuring Professor
Gerhard Bauer & Catalent's James Crutchley
as they discuss challenges and an innovative
methodology to commercially scale autologous
cell therapies in this on-demand webinar.
Download

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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
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Catalent eBook - 12
Catalent eBook - 13
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Catalent eBook - 15
Catalent eBook - 16
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Catalent eBook - 20
Catalent eBook - 21
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