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Bisschops, Marc

Fuente, Ruth de la

English

Engineering Conferences International

 Poster Number 50 MODEL ASSISTED DESIGN OF AN INTENSIFIED BIOPROCESS  Ruth de la Fuente, Pall Corporation, Germany ruth_delafuente@pall.com Marc Bisschops, Pall Corporation, Germany   Key Words: Process Modeling; Process Optimization; Intensified process design  Over the past decade, various case studies have been presented to demonstrate the feasibility of integrated intensified and continuous bioprocessing platforms [1 – 6]. The design of these intensified or continuous manufacturing processes relied on establishing process conditions in the reference batch process steps. In all case studies presented, the product quality obtained in the intensified process aligned very well with the profile generated in the reference batch process.   This suggests that the decision criteria for designing an intensified bioprocess can be based on the overall design space based on critical process parameters obtained from (lab scale) batch process experiments. In this poster, a model assisted process design will be presented that allows tailoring the manufacturing platform to meet the business needs and/or constraints of the overall manufacturing operations. This could include facility fit considerations, cost considerations, buffer consumptions or any other business driver. The model accommodates the design of the process steps based on the critical process parameters for each unit operation and allows the user to assemble an intensified platform in which continuous process steps, repetitive (rapid) cycling process steps and traditional batch process steps are combined. By aligning the cyclic nature of various unit operations, regulatory aspects such as material traceability can be considered. The poster will present some examples how one (bench scale) reference process can lead to different process platforms, depending on the specific optimization criteria and boundary conditions of the manufacturing environment.    References: 1. GEN: “First mab produced via fully continuous biomanufacturing”, Genetic Engineering News (24 SEP 2019) 2. BiosanaPharma: “BiosanaPharma announces successful outcome of comparative phase I study of BP001, a biosimilar candidate to Xolair® (omalizumab)”, Press Release (30 MAR 2020) 3. M. Brower and D. Pollard: “Monoclonal Antibody Continuous Processing Enabled by Single-Use”, in: G. Subramanian (ed.): “Continuous Processing in Pharmaceutical Manufacturing”, Wiley VCH (2015) 4. V. Warikoo et al.: “Integrated Continuous Production of Recombinant Therapeutic Proteins”, Biotechnol.Bioengng., 109 12 (2012) pp. 3018-3029 5. L. David et al.: “Side-by-side comparability of batch and continuous downstream for the production of monoclonal antibodies”, Biotechnol.Bioengng., 117 (4) (2020) pp. 1024-1036 6. O. Ötes et al.: “Moving to CoPACaPAnA: Implementation of a continuous protein A capture process for antibody applications within an end-to-end single-use GMP manufacturing downstream process”, Biotechnololgy Reports, 26 (2020)  7. A. Utturkar et al.: “A Direct Approach for Process Development Using Single Column Experiments Results in Predictable Streamlined Multi‐Column Chromatography Bioprocesses”, Biotechnol.J., 14 (4) (2019)  

Model assisted design of an intensified bioprocess

https://dc.engconfintl.org/cgi/viewcontent.cgi?filename=0&article=1083&context=biomanufact_v&type=additional

Model assisted design of an intensified bioprocess

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Engineering Conferences International