Luncheon

Oct. 12 (Thu.) ,2017 12:00-13:00

Annex Hall
F202

Simultaneous Interpretation

【L-4】 Nikon CeLL innovation / Lonza Japan

Development of cGMP compliant manufacturing processes that ensure safety and quality of Cell Therapy/Gene Therapy products for regenerative medicine: our approach and experience

Establishing manufacturing process under current Good Manufacturing Practices (cGMP) is the key for production of high quality Cell Therapy (CT) and Gene Therapy (GT) products. To ensure safety and quality of the CT/GT 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 regarding the development of cGMP compliant manufacturing processes at Lonza. Nikon CeLL Innovation will introduce GCTP/cGMP compliant CDO/CMO facility and its services located in Tokyo, under Nikon-Lonza Partnership.

Coordinator

Takahiro Nakano

Senior Sales Manager, APAC Cell Therapy/Viral Therapy, Lonza Japan

The Future of Gene Therapy Manufacturing - Addressing Growing GMP Demands with Flexible Facilities and Novel Technologies

Ryan Scanlon

Head of Viral Gene Therapy, Lonza Pharma & Biotech

Addressing Manufacturing Challenges for Expansion and Directed Differentiation of Pluripotent Stem Cells at Commercial Scale

Behnam Ahmadian Baghbaderani

Head of Cell Therapy Development, Emerging Technologies, Lonza Pharma & Biotech

CDMO Facility Introduction of Nikon CeLL innovation Co., Ltd.

Toshiyuki Nakayama

President, Nikon CeLL innovation

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