TY - GEN
T1 - From Discovery to Production
T2 - 2022 Winter Simulation Conference, WSC 2022
AU - Xie, Wei
AU - Pedrielli, Giulia
N1 - Funding Information:
We acknowledge Hua Zheng and Keqi Wang (Northeastern University) for their help on the paper preparation. This work was partially supported by the grants NSF#2046588-2007861 (PI Pedrielli) and NIST#70NANB21H086 (PI Xie).
Publisher Copyright:
© 2022 IEEE.
PY - 2022
Y1 - 2022
N2 - The increasingly pressing demand of novel bio-drugs (e.g., gene therapies) with unprecedented levels of personalization, has put a remarkable pressure on the traditionally long time required by the pharma R&D and manufacturing to go from design to production of new products. In fact, practitioners are increasingly moving away from the classical paradigm of large-scale batch production to continuous biomanufacturing with flexible and modular design, which is further supported by the recent technology advance in single-use equipment. In contrast to long design processes, low product variability (one-fits-all), and highly rigid systems, modern pharma players are answering the question: can we bring design and process control up to the speed that novel production technologies give us to quickly set up a flexible production run? In this tutorial, we present key challenges and potential solutions in terms of new bioprocess modeling and control strategies for integrated design and manufacturing of next generation bio-drugs.
AB - The increasingly pressing demand of novel bio-drugs (e.g., gene therapies) with unprecedented levels of personalization, has put a remarkable pressure on the traditionally long time required by the pharma R&D and manufacturing to go from design to production of new products. In fact, practitioners are increasingly moving away from the classical paradigm of large-scale batch production to continuous biomanufacturing with flexible and modular design, which is further supported by the recent technology advance in single-use equipment. In contrast to long design processes, low product variability (one-fits-all), and highly rigid systems, modern pharma players are answering the question: can we bring design and process control up to the speed that novel production technologies give us to quickly set up a flexible production run? In this tutorial, we present key challenges and potential solutions in terms of new bioprocess modeling and control strategies for integrated design and manufacturing of next generation bio-drugs.
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U2 - 10.1109/WSC57314.2022.10015464
DO - 10.1109/WSC57314.2022.10015464
M3 - Conference contribution
AN - SCOPUS:85147416689
T3 - Proceedings - Winter Simulation Conference
SP - 238
EP - 252
BT - Proceedings of the 2022 Winter Simulation Conference, WSC 2022
A2 - Feng, B.
A2 - Pedrielli, G.
A2 - Peng, Y.
A2 - Shashaani, S.
A2 - Song, E.
A2 - Corlu, C.G.
A2 - Lee, L.H.
A2 - Chew, E.P.
A2 - Roeder, T.
A2 - Lendermann, P.
PB - Institute of Electrical and Electronics Engineers Inc.
Y2 - 11 December 2022 through 14 December 2022
ER -