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FEATURED REPORT
BioProcess
International
Manufacturing
Cell and Gene
Therapies
APRIL 2026
01 Introduction: Getting Advanced Therapies into Patients
Cheryl Scott
04 Overcoming Data Sharing and Standardization Hurdles
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07 Blood Centers: A Ready Partner
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09 CAR-T Operations: Making Personalized Medicine a Reality
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12 Exploring Nonviral, In Vivo CAR-T Therapy Production
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18 Integrating Quality by Design (QbD) Principles
into Gene-Therapy CMC Programs
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23 Designing for Manufacturability
and Product Quality
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28 Supporting a Maturing Modality
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Choose experience
over trial and error
Your
FEATURED REPORT BioProcess International Manuf
Choose experience over trial and error Your CDMO
Introduction Getting Advanced Therapies into Pati
selection for gene therapies and in vivo cell the
Devices increasingly are codeveloped alongside co
Data Sharing and Standardization Hurdles Accelera
standards and platforms are necessary, persistent
checks. The industry also must enhance its unders
Blood Centers A Ready Partner in Building Reliabl
The path from collection to treatment in CGT deli
CAR-T Operations Making Personalized Medicine a R
STRATEGIC OPERATIONS Chain of identity and chain
GUIDANCE AND COLLABORATION As CAR-T programs expa
Exploring Nonviral, In Vivo CAR-T Therapy Product
endotoxins, host-cell proteins (HCPs), and genomi
Achieving SELECTIVE T-cell transfection represent
targeted LNPs efficiently deliver mRNA to T cells
For bioprocess engineers and manufacturing scient
higher in target T-cell populations, with robust
Integrating Quality by Design Principles into Gen
· input material controls — e.g., qualificat
manufacturers to tighten acceptance criteria as d
validated for accuracy, precision, specificity, a
inseparable, and a well-structured QbD framework
Designing for Manufacturability and Product Quali
options. However, such operations require multipl
MANUFACTURABILITY TRADE-OFFS AAV manufacturing is
)LJXUH ɄBalancing innovation in adenoassociated v
therapies progress, next-generation programs will
Supporting a Maturing Modality Large-Volume Manuf
differentiate inadvertently into non–stem-cell ph