BIO Asia–Taiwan 2022 亞洲生技大會

BIO Asia–Taiwan 2022 亞洲生技大會

講師

Karen Wen

Session 12 – Biologics Product Development and Manufacturing

Date:29 July (Friday)
Time:  10:40 – 12:10 (GMT+8)

Karen Wen

COO
​GenomeFrontier Therapeutics Inc.

Karen Wen is a pioneer in the field of biological product development specialized in process development and PIC/S GMP production including peptide, proteins, monoclonal antibodies, DNA vaccine and antibody-cell conjugate product and is expanding her professionals in the area of gene and cellular therapy. Karen is the co-founder and ex-CEO of Mycenax Biotech Inc. (2001~2011 as VP and 2011~2018 as CEO), the first biological CDMO in Taiwan. In her service in Mycenax, 17 projects in the development, more than 300 batches of GMP production, one follow-on biological product launched and one biosimilar product successfully out-licensed its European right to a European big pharmaceutical company in 2020. Besides of the product development, Karen set up the GMP system of the facility and led this facility as the first one to adopt single use technology in Asia and the first 2000L, the largest, disposable bioreactor in the world. She also led Mycenax to collaborate with Biosana to pursue the development of full-line continuous manufacturing as the pioneer getting into the clinical phase.

In March 2019, she joined GenomeFrontier Therapeutics Inc. (GF), a startup company for gene and cell therapy, as the Chief Operation Officer and Chief Strategy Officer to assist the founder, the technology inventor, to bring her research findings to the clinical phase. GF is the company using proprietary virus- free system to deliver gene to immune cell for gene and cellular therapy purpose and qCART™ system is the first system established for CAR-T therapy. This disruptive innovation is expected to provide CAR-T therapy for a better efficacy in the solid tumor treatment. This convivence and cost effectiveness of this virus-free gene manipulation system would lead the gene and cellular therapy into the new era. 

Karen served in DCB from 1993~2000 in the group of IVD products Karen after she got her Ph.D. degree in Biomedical Science in Old Dominion University/Eastern Virginia Medical school.  

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