Bench to the manufacturing suite: Scale-up, tech transfer

Commercialization of fermentation processes often involves scaling from very small volumes (~ 1 mL) to thousands of liters. Many parameters important to fermentation do not scale in a straight-forward manner and can be difficult to measure at large scale. This of course makes fermentation scale-up both challenging and rewarding when solved. Some of these challenges include differences in oxygen transfer, mixing, shear, raw materials, measurement systems, heterogeneity, and equipment capability. This session will give scientists and engineers a chance to share their research, experiences, and insights into delivering a process to the marketplace and sustaining that process after commercialization.

Conveners

Chris Stowers – Corteva Agriscience
Frank Agbogbo – Cytovance Biologics

Continuous manufacturing: Opportunities and limitations

Continuous Manufacturing is a relatively new and emerging field in the area of industrial fermentation, although well implemented in many other fields such as the oil, power, food and chemical industries.

The session welcomes contributions presenting both the opportunities and limitations of continuous bioprocesses. Opportunities and advantages of continuous manufacturing can include, for example: reduced plant size, increased consistency, reduced operation cost, single use (disposable) bioreactors, and more. Challenges and limitations met when trying to import this system can include fitness of Continuous Manufacturing to the Biotech and Pharmaceutical industries: for instance in the development of proper scale-down models, identification of stable clones, control of contamination, linking upstream processes to downstream processes, level of productivity, batch definition, regulatory issues and more.

Conveners

Ghil Jona – Weitzmann
Farzaneh Rezaei – Pivot Bio
Johan Westman – Chr Hansen

Cell factory design and engineering

With the advent of a more holistic approach in bioprocess development, cell factory design and engineering have reached the next level of sophistication. Systems-driven target identification and the widespread use of genome editing tools and automated HT scale-down systems, have enabled industry and academia to accelerate the design of optimized cell factories. This applies equally to classical microbial workhorses such as E. coli and S. cerevisiae, mammalian expression systems and novel hosts. However, the full benefit of these new workflows can only be harvested when critical product quality attributes and other regulatory requirements, eg. strain stability, also can be addressed in a high-throughput manner during the early stages of development. This session aims at showcasing recent advances in the development of microbial and mammalian expression systems and the methods used for screening to develop high-quality and high-titer processes for the production of recombinant proteins and value-added chemicals.

Conveners

Peter Becker – Glycom Denmark A/S
Shushil Machhi – Medimmune
Haitao Zhang – Bayer

Lessons learned, best practices, and case studies in fermentation – Opportunities, Challenges and overcoming them – Round Table

With recent advances in microbial strain development technologies, fermentation derived products are increasingly impacting diverse industries from pharmaceuticals, fuels and chemicals to food, textiles and personal care. This explosive growth in fermentation technology brings with it an improved understanding of best practices, key challenges and ideas on overcoming them. Whether it is variation in raw material quality, reliability of mathematical models, the small number of available direct process measurements, or dealing with contamination, partners or regulations, there are several challenges we have all faced in the course of scaling up and commercialization. In this session, we want to highlight some such challenges, discuss how to overcome them and identify opportunities for continued impact of fermentation processes.

Conveners

Smita Shankar – Impossible Foods
Katelijne Bekers – Ohly

Big data, AI and machine learning – Disruption in strain engineering and bioprocess development

Fast computation and inexpensive DNA synthesis enables opportunities to improve the design-build-test cycle in strain engineering and fermentation. Genomics and proteomics data are mined for potential metabolic pathways. Large, parallel, miniaturized experiments test numerous hypotheses in the microbial and fermentation design space and feed machine-learning models. Metabolic modeling and simulations can identify novel pathways, create genetic regulatory networks, and drive improvements in gene expression. High throughput fermentation platforms drive process optimization and media screening while generating data for modeling and process development. This wealth of information requires improvements in data analysis and decision making. This session will address recent uses of big data, AI, and machine learning towards improvements in strain and fermentation.

Conveners

Keith Alsaker – Evonik
Ashish Sharma – NIH
Firehiwat Tachea – Culture Biosciences

When the revolution comes: Matching supply and demand at the confluence of synbio, industrial biotech and manufacturing – Round Table

Supply and demand of manufacturing capacity is a critical factor in the growth of the Bioeconomy. On the demand side developers are often small companies with limited budgets developing drop in replacements in competition with powerful incumbents, or disruptive products where market pull is not established. In either case sales volumes and timing are notoriously difficult to establish. On the supply side contract manufacturing of bio-products is challenging partly due to the variety of process requirements, the large CAPEX and operational investment required to service clients and by the lack of market certainty.

Consequently, developers often struggle to raise finance due to limited manufacturing options, while contract manufacturers (CMOs) are unable to invest in capacity due to the inability of those developers to commit. This is a chicken and egg situation that is hampering the commercial penetration of biological products. With the rapid advances being made by synbio exponents and increased market pull for biobased and biodegradable materials will we suffer an enormous production capacity shortage or will CMOs be left sitting on empty assets?

This session will bring together industry experts from both sides of the fence to present their visions of the future and to debate the challenges and needs. The audience can participate fully with lively and thoughtful discussion and through a questionnaire that will be used to inform the discussion. We will seek to provide some clarity to the question of manufacturing capacity demand. CMOs and product developers are invited to submit abstracts to an associated poster session to inform the conference on challenges and production capacity and availability.

Conveners

Tim Davies – Rubus Scientific
Yaoping Zhang – University of Wisconsin – Madison

Poster Sessions (Sunday and Monday)

Conveners

Nancy Dowe – NREL