Date：29 July (Friday)
Time: 10:40 – 12:10 (GMT+8)
Transcenta HoldingHJB, a subsidiary of Transcenta Holding (CDMO)
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.