
The Top Line
Advancements in cell & gene therapy manufacturing (Part II)
May 17, 2024
Delara Motlagh, Becky Butler Cap, and Kevin Kyle discuss cell collection, scaling projects from lab to clinic, and Germfree's decentralized manufacturing mission. Topics include locking in process decisions early, Catalent's new production site, and Germfree's recent asset acquisition from Orgenesis.
31:23
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Quick takeaways
- Locking in process decisions early is crucial in advanced therapy manufacturing.
- Transition towards closed system manufacturing in controlled environments is essential for reproducibility and reduced risks.
Deep dives
The Vital Role of Manufacturing Process in Cell and Gene Therapies
Manufacturing in cell and gene therapies is crucial due to the unique nature of living therapies. The process is essential as cells for these therapies exhibit inherent variability. Additionally, the intellectual property is linked to the manufacturing process, emphasizing its criticality and role in commercialization. The industry is advancing towards standardization, improved analytics, and quality management to address these complexities.
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