BIO Asia–Taiwan 2022 亞洲生技大會

BIO Asia–Taiwan 2022 亞洲生技大會

TEACHER

Christopher Hwang

Session 12 – Biologics Product Development and Manufacturing

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

Christopher Hwang

EVP, CTO
Transcenta HoldingHJB, a subsidiary of Transcenta Holding (CDMO)

 

 
Chris has over 30 years of experience in biopharmaceutical industry.  He is responsible for developing and implementing cutting-edge technologies to achieve best–in-class CMC development and manufacturing while dramatically reduce cost of goods to expand patient access to innovative biologics.  Prior to joining Transcenta in 2016, he spent 25 years at Genzyme and Sanofi, most recently as Senior Director in Late-Stage Process Development and was the program lead for the industry leading integrated continuous biomanufacturing (ICB) platform.  He has extensive experience in product and CMC development, technology transfer, GMP manufacturing and support.  Previously he managed departments responsible for cell culture and microbial fermentation development, process analytics, gene therapy development, clinical manufacturing, project portfolio management and was the Technical Lead for a number of clinical and commercial stage products at Genzyme and Sanofi.  He is a member of the Parenteral Drug Association’s (PDA) Biotechnology Advisory Board, and he received his Ph.D. in biochemical engineering from Massachusetts Institute of Technology.

 

Speech title & Synopsis

DEVELOPMENT AND INDUSTRIALIZATION OF ADVANCED BIOMANUFACTURING PLATFORM TO ADDRESS BUSINESS NEEDS AND AFFORDABILITY OF BIOLOGICS

Industry challenges stem from drug pricing pressure, demand uncertainty, increasing competition, and need for rapid response are driving innovations in biomanufacturing.  To achieve the high quality, speed, flexibility, and low cost needed to address these challenges, Transcenta/HJB is developing and implementing novel technologies to achieve our vision of “small and nimble” facility with “output of much larger”.  
Here, we present our vision of the future of biomanufacturing which integrates both advanced biomanufacturing platform and facility design, and our 5-year plan (2018 – 2023) to develop and implement this universal production platform in GMP manufacturing.  We will share our progress to-date on intensifying our processes and securing the technology needed to support industrialization.  From a process intensification perspective, we will share significant progress made in achieving high volumetric productivities and consistent product quality in continuous perfusion processes for multiple cell lines (achieved up to > 6 g/L-day state of control) and commercial scale GMP manufacturing.  In addition, in close collaboration with Merck KGaA, we will showcase for the first-time, a continuous downstream process equipment that includes a single-use integrated capture technology and single-use polishing downstream technology “Combo” that connects and automates four-unit operations.  These downstream technologies are part of the key enabling technologies for debottleneck plant output are on track for full scale GMP operation in Q1’23.  Lastly, we will also present our implementation strategy for our pipeline molecules at different stages in development; balancing risks (technical, operational, and regulatory), benefits, and speed of adoption, to ensure speed to clinic and a route to full implementation at commercial scale to maximize plant output and drive down cost of goods.


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