Open Stage Seminar Oct. 13 (Fri.) ,2017 13:00-13:10

【Company Presentations】

Lonza Japan

FIRM

Takahiro Nakano

Senior Sales Manager, APAC Cell Therapy/Viral Therapy

Development of cGMP compliant manufacturing processes that ensure safety and quality of Cell Therapy products: Lonza’s approach and experience

 

Establishing manufacturing process under current Good Manufacturing Practices (cGMP) is the key for production of high quality Cell Therapy (CT) products. To ensure safety and quality of the CT products, it is necessary to establish a robust and reproducible cGMP compliant process through careful implementation of important design considerations during the process development activities. These design considerations must be applied to the entire manufacturing process. We will highlight our approach and experience by using the development of cGMP compliant manufacturing processes for clinical-grade iPSCs at Lonza Walkersville, as a case study.

 

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