HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner


Sep, 2023


Sep, 2023

Presenting on Cell Culture & Upstream Processing



Establishing comparability between fed-batch and intensified perfusion: Journey from batch to integrated continuous commercial biomanufacturing process

Industry challenges stem from increasing competition, demand uncertainty, drug pricing pressure 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, H has developed a novel bioprocessing platform (HiCB) that is operating in our flexible single-use modular facility to achieve our vision of “small and nimble” facility with “output of much larger”. Here, we share our progress to-date on process intensification and securing the technology needed to support industrialization. We have achieved very high volumetric productivities for multiple cell lines (up to 7 g/L-day) in continuous perfusion platform while maintaining product quality in state of control. To ensure HiCB process is implemented for late stage and commercial manufacturing, we will share a case study where we successfully converted a fed-batch process to intensified continuous perfusion, increasing process output by 8X and established product comparability and received go ahead from FDA and CDE. Lastly, to ensure downstream processing is highly intensified to maximize output in a multi-product facility, we will showcase our hybrid continuous downstream platform that includes a single-use integrated capture multi-column chromatography system (MCC) and single-use flow through polishing technology (“Combo”) that connects and automates four-unit operations. User requirement and design principles for this intensified downstream platform will be discussed, balancing risks (technical, operational, and regulatory), benefits, and speed of adoption.

Cell Culture & Upstream Processing - Room 210C
 4:00pm - 4:30pm

EST/EDT (Eastern Daylight, GMT-4)



Christopher Hwang

Chief Technology Officer, HJB

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