Current prospective on biosimilars: Development to the marketplace
The first regulatory application for a biosimilar monoclonal antibody was submitted to the EMA in 2012. Today there are a number of Biosimilars that have been approved and many more in development at companies around the world. Biosimilars offer companies the opportunity to expand their product portfolios without having to discover a new molecule/treatment and offer patients a therapeutic at a potentially lower cost than the originator thus increasing availability. The timelines to develop a biosimilar are becoming shorter and shorter and at the same time the analytical requirements continue to increase as analytics improve and “biosimilarity” is further defined. There have been significant improvements in cell lines and productivity for new products launched over the last few years, but those productivity improvements are not always captured in processes for biosimilars because of the requirement to be similar. In this session, the presentations will explore the development and commercialization process for biosimilars including the process and analytical data packages needed for scale-up and commercialization.
Frank Agbogbo – Cytovance Biologics
Tiffany Rau – BioProcess Technology Consultants, Inc.
Advances in fermentation of microbial communities/mixed cultures session
With few exceptions (e.g., wastewater treatment), industrial microbiology has centered on the optimized cultivation of single microbial strains. Increasingly, it is becoming clear that microbial consortia may provide viable, even preferable, alternatives for the production of bio-based compounds. This session will feature presentations that describe the development, characterization and utilization of microbial communities/mixed cultures in biotechnology
Kris Prather – MIT
Gionata Scalcinati – Genomatica
Microbial lipid production
Microorganisms synthesize a wealth of different lipid molecules that have many application potentials in food and non-food industrial sectors. With the advancement of bioprocessing technology including strain improvement and fermentation innovation, many of these microbial lipids have/will become commercial reality. Papers in this session will present advances in the fermentative production and application testing of several microbial lipids with high commercial potential.
Dan Solaiman – USDA-ARS
Inge Van Bogaert – Ghent Univ.
From zero to hero – Integrated approach for strains, fermentation, process & DSP developments
The ultimately goal of process development is commercialization of a high quality biological product with best cost performance. From sophisticated engineered strains to none-GMO production organisms, from applications such as agriculture, detergents to biopharmaceuticals, with products such as chemicals to proteins to microbes, using fermentation processes as simple as batch or fed-batch to continuous or fully automated fermentation, through whole-cell product recoveries or highly purified ones, formulated as liquids or dry powders or granules, the challenges are plentiful and the variables are endless. In this session, we want to discuss how to create process knowledge, achieve commercialization and manage risks by highlighting the interdependency of all process functions.
Janine Reimann – BASF
Jeff Pucci – DuPont
Non-GMO base strain and fermentation process development
Recent advancement in synthetic biology has led to great progress in our ability to modify microbial genomes for improved industrial application. However, in certain areas, in particular food and environmental release applications, the use of genetically engineered microorganisms (aka GEMs) may be limited due to regulatory concerns and public resistance. This session will focus on non-recombinant DNA techniques to improve base strain performance in industrial fermentation. This includes bioprospecting for new strains with unique characteristics, improving strain performance by classical mutagenesis, adapting strains to a set of cultural conditions (adaptive evolution), as well as combining traits by natural mechanisms such as conjugation and transduction. Techniques employed to screen large numbers of variants for beneficial mutants will also be included. Finally, appropriate safety evaluation methodology will be reviewed: what really matters to microbial safety?
Haowen Xu – BASF
Vincent Sewalt – DuPont
Frontiers in fermentation: Uncommon microbes
Industrial fermentation is dominated by a handful of reliable mainstays like S. cerevisiae and E. coli. Yet there is an almost unlimited potential for innovation that only recently has started to come into focus through the use of lesser known microorganisms in a variety of applications. The products of these fermentations range from human health to renewable fuels, from bioremediation to new bio materials. In this session, we will explore the advantages and challenges of cultivation, analysis, scale-up, and commercialization in these (as of now) unusual fermentations.
Sabrina Trupia – AB Mauri
Fermentation process development for non-conventional feedstocks or cell-free systems
Recent years have seen rapid development of processes that utilize non-conventional feedstocks and/or make use of cell-free systems to enhance biorefinery economics and provide significant environmental benefits. Non-conventional feedstocks including CO2/CO (e.g. waste streams of power or processing plants), syngas, methane, lignin and other waste streams provide a low-cost alternative to the use of sugars and offer significant greenhouse gas reduction potential. Cell-free systems allows to bypass the complexity and constraints of living cells and provide safeguards for biocontainment. Importantly, both the use of non-conventional feedstocks and cell-free systems allow for high-yields. This session will focus on development of new processes for utilization of non-conventional feedstocks and application of cell-free systems for production of fuels, chemicals and other products and will cover the challenges from bio-discovery over the proof-of-concept stage, prototyping and process optimization to full scale industrial production.
Michael Koepke – LanzaTech
Katy Kao – Texas A&M Univ.