Successes and Challenges in Biomanufacturing Proceedings of a Workshop–in Brief (2023) / Chapter Skim
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Successes and Challenges in Biomanufacturing: Proceedings of a Workshop - in Brief
Successes and Challenges in Biomanufacturing: Proceedings of a Workshop - in Brief
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To share practices and potential solutions, by participants in the context of multiple topics (e.g., the National Academies of Sciences, Engineering, workforce development and biomanufacturing scaleand Medicine hosted a workshop titled Successes and up capacity) and were discussed as relevant to multiple Challenges in Biomanufacturing on October 24-25, sectors of biomanufacturing.
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bioeconomy stakeholders is funding startup biomanufacturing companies and can learn from these international policies and actions, its Regional Innovation Engines program aims to which include industry incentives for biogenic carbon catalyze a regional innovation ecosystem that includes capture and business models for sustainable mobilization biotechnology and biomanufacturing. and valorization of agricultural residues, including through industrial symbiosis.
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One advantage of biomanufacturing is that agriculturally produced carbon sources are local, creating the potential Fahie noted that there has been good work establishing to address supply chain issues, said Guillaume Lamy guidelines and metrics for measuring and reporting MARCH 2023 | 3
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He added expand manufacturing capacity; secure supply that detailed, prescriptive regulation might not be as chains, cybersecurity, and other infrastructure; and appropriate as well-articulated principles of practice streamline regulatory review and enable international because of this diversity and rapid innovation in the field. harmonization.
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said BioMADE has three Baker noted that one challenge to modernizing the focus areas in its workforce development program: biopharmaceutical industry is industry's increasing risk building awareness of bioindustrial manufacturing aversion in deploying new manufacturing technologies careers, preparing the future workforce with innovative and control strategies. He added that this comes education, and supporting the growth of the current from a perception that questions from regulatory workforce with world-class professional development.
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With colleagues communities so community leaders, parents, students, from the biomanufacturing industry, Ryder created a and educators can learn about the opportunities and Master of Bioprocess Engineering program that includes start conversations that can spark a student's interest in hands-on training with bench-scale and pilot-scale pursuing a biomanufacturing career. bioprocessing equipment common to biopharmaceutical, industrial biotechnology, and food technology processes.
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said there are common would kill the organism. Mukherjee said, in principle, themes for why companies in this space fail, starting he sees no constraints from a technology perspective with the fact that while a technology might be exciting, regarding industrial chemicals aside from the perspective technology is a feature, not a complete solution to of cost and life-cycle analysis.
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Friedman said has created a culture around shared manufacturing having customer validation, a positive economic analysis, technology innovation that enables companies to and robust technology opens the door to private capital share their experiences and knowledge and innovate investment and a promising business model. collaboratively.
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described how her diseases, Lee said NIIMBL aims to address a significant company captures waste carbon and transforms it into challenge -- the lack of a viable commercial market -- by sustainable products already on the market using biology, developing open platform processes for gene therapy another example of industrial symbiosis discussed at vectors that FDA could approve and developers could the workshop. Holmgren described how they do this use to deliver a specific gene of interest.
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Balakirsky said a that experimental data can then be used to estimate robust, open-source software community in the cell initial model parameters and iteratively improve a model. therapy manufacturing space is working on planning Data quality and reproducibility are critical for predictive and control algorithms and communication frameworks analytics, said Theresa Kotanchek (Evolved Analytics)
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, requires scaling mammalian cell production challenge, he said, is to develop a system for distributed methods developed by the biopharmaceutical industry manufacturing, a key feature of autologous cell therapy, by many fold and at a much lower cost. He added that that can gain regulatory approval.
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noted that million liters of fermentation capacity across different infrastructure innovation needs to go beyond fermentation scales, including the pilot scale (1,000-5,000 liter and include downstream processing, particularly given fermenters) through the commercial scale (190,000 liter the diversity of downstream processes required for fermenters)
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