2 BioPharm International eBook Quality and Regulatory Sourcebook eBook March 2024 www.biopharminternational.com
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I N T E R N AT I O N A L
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Contents
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CELL AND GENE THERAPIES
Phase-appropriate Compliance
for Cell and Gene Therapies
Zhongren Wu, Siegfried Schmitt, and Lynne Ensor
Understanding how to apply phase-appropriate GMPs
is crucial for achieving successful regulatory approval. 4
RISK MANAGEMENT
Shining a Light on the Long Shadow of
Subjectivity in Quality Risk Management
Amin Ziaie, Anne Greene, and Marty Lipa
This article explores the emergence
of subjectivity in ICH Q9 (R1). 7
QUALITY BY DESIGN
Digitalization of QbD Risk Assessments
Gayathri Acharya, Matthew Pincus,
Hervé Gressard, and Phil Borman
Quality-by-design risk assessment workflows
digital transformation can improve efficiency,
reduce human errors, and facilitate integration
within a much broader digital ecosystem. 12
MANUFACTURING
Review of SUT Adoption
in Biopharma Manufacturing
Ramesh Raju Mavuleti, K. Vasantakumar Pai,
K. Sreedhara Ranganath Pai, Subhasis Banerjee,
Somasundaram Gopalakrishnan, and Tathagata Ray
The evolution of therapeutic modalities
drives the adoption of single-use technologies. 19
Quality and Regulatory
Sourcebook March 2024
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EDITORIAL
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Curia ................................................................................................. 3
Entegris........................................................................................... 13
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