Upstream Processes

Area Coordinators: Ian Wheeldon, Nitin Agarwal, Inn Yuk

Upstream Processes:

Session: Automated Technologies and High-Throughput Systems in Biologics Production: Upstream Processing

Session: Disruptive Bioprocessing and Process Integration: Upstream Processing 

Session: Antibody Drug Conjugates and Novel Formats

Sessions I and II: Mammalian Cell Culture Process Development

Session: Control of Product Quality Attributes 

Session: Microbial and Non-Model Hosts: Strain Engineering and Process Development

Session: Metabolic Engineering and Synthetic Biology

Session: Systems Biology and Omics Applications

Session: Engineering Natural Products Biosynthesis


 

Session: Automated Technologies and High-Throughput Systems in Biologics Production: Upstream Processing

Session chairs:

Name: Albert Schmelzer

Affiliation: MedImmune

Email: schmelzera@medimmune.com

 

Name: Mike Jewett

Affiliation: Northwestern University

Email: m-jewett@northwestern.edu

 

Session description:

Automation has the potential to accelerate discovery of lead candidate biologics through realizing greater efficiencies, reduced timeframes and reductions in human error. In addition, timeline pressures due to intense competition require automation to develop well-characterized, scalable manufacturing processes for high-quality biotherapeutics.

In this session, we invite contributions focused on miniaturization, automation, and massively parallel synthesis and analysis of protein-based drugs — such as recombinant proteins and monoclonal antibodies. This includes the latest developments in (i) experimental approaches for high-throughput protein production, including microbioreactors, (ii) integration of online or at-line analytics for biomanufacturing, (iii) computational approaches necessary to support experimental innovations, and (iv) application of such approaches to key biomedical systems relevant in biotechnology, therapeutic development, and biologics production. Examples include but are not limited to: automated methods in protein expression; high-throughput perfusion scale-down models, self-tuning/optimizing bioreactors, and automation of nutrient additions via PID loops. Case studies as well as efforts evaluating these technologies are especially encouraged.

 

Session: Disruptive Bioprocessing and Process Integration: Upstream Processing 

Session chairs:

Name: Anli Ouyang

Affiliation: Lilly

Email: ouyang_anli@lilly.com

 

Name: Nanette Boyle

Affiliation: Colorado School of Mines

Email: nboyle@mines.edu

 

Session description:

Upstream manufacturing processes have become increasingly productive and scalable for a wide variety of therapeutic proteins. However, cost and timeline pressures motivate process development scientists and researchers – both industrial and academic – to find new, disruptive ways to produce consistent, high-quality proteins in our manufacturing processes. Recent advances in targeted integration, assurance of clonality of production cell line, process intensification, advanced process control, integrated continuous bioprocessing and single-use systems – among others – have enabled this new wave of innovation in process design and process integration. In this session, presentations discussing these disruptive technologies (but not limited to) are welcome. Case studies including using these disruptive new technologies to accelerate development, to reduce the cost or to improve the quality are especially encouraged. 


Session: Antibody Drug Conjugates and Novel Formats

Session chairs:

Name: Pani Apostolidis

Affiliation: BMS

Email: pani.apostolidis@bms.com

 

Name: Xin Ge

Affiliation: University of California, Riverside

Email: xge@engr.ucr.edu

 

Session description:

Molecular and cellular science and engineering efforts over the past decade have given rise to numerous novel approaches for treating disease. These approaches, utilizing novel biologic modalities beyond the traditional monoclonal antibodies, have substantial potential to provide highly specific and efficacious therapies for challenging disease targets, for instance, persistent pathogen infections, neurodegenerative disease, and cancer. This session will focus on upstream manufacturing and process development challenges for such novel biologic modalities. Applicable topics include case studies on process development, scaling-up and manufacturing of antibody-drug conjugates, bi-specific antibodies, gene therapy / RNA interference vectors as well as other novel therapeutic biologic formats.  Furthermore, case studies on facility fit considerations for manufacturing flexibility and equipment design for process development and manufacturing of novel biologic modalities are applicable to this session. 

 

 

Sessions I and II: Mammalian Cell Culture Process Development

Session chairs:

Name: Niraj George

Affiliation: GSK

Email: niraj.p.george@gsk.com

 

Name: Sarah Harcum

Affiliation: Clemson University

Email: harcum@clemson.edu

 

Name: Michael Cunningham

Affiliation: MilliporeSigma

Email: michael.cunningham@emdmillipore.com

 

Name: Inn Yuk

Affiliation: Genentech

Email: inn@gene.com

 

Session description:

Mammalian cell culture has become an essential means for production of an ever-increasing number of viral vaccines, recombinant proteins, monoclonal antibodies and other biopharmaceuticals. In addition, the role of cell culture is even further expanded with the advent of cell-based therapy and gene therapy, where the desired products are the cells (e.g., t-cells and stem cells) or viral capsids encoding the gene of interest. The field has matured into a multidisciplinary activity including genetic manipulation of cell lines to obtain highly productive clones, medium and feed development, bioreactor characterization, and process control to optimize conditions for desired productivity and product quality. This session will encompass multiple aspects of mammalian cell culture development, including advances in the development of improved production vectors, novel clone selection strategies, engineering of host cell lines, cell expansion strategies, metabolic pathway analysis, media development, multivariate analysis of processes and innovative process development. Papers relevant to these topics are highly encouraged, including those focusing on process and equipment strategies for ultra-high cell mass and productivity, new technologies to improve and/or characterize process performance, case studies on issues encountered during late stage process development including persistent or newer issues of low productivity, scale-up for commercialization, and management of raw material changes. 


Session: Control of Product Quality Attributes 

Session chairs:

Name: Melissa Mun

Affiliation: Genentech

Email: mun.melissa@gene.com

 

Name: Yongku Cho

Affiliation: University of Connecticut

Email: cho@engr.uconn.edu

 

Session description:

This session will focus on advances in tools to control product quality attributes through process or raw material modifications, cell line engineering, or other strategies. The session welcomes papers describing improved post-translational processes such as cellular quality control, glycosylation, and chemical functionalization. Papers that link process conditions and product quality with underlying cell physiology and metabolism, either experimentally or computationally, are encouraged. All recombinant production host systems will be considered, including but not limited to bacteria, yeast, insect cells, mammalian cells, and plant cells. Advances in cell-free protein expression will also be included.

  

Session: Microbial and Non-Model Hosts: Strain Engineering and Process Development

Session chairs:

Name: Karthik Veeravalli

Affiliation: Genentech

Email: veeravalli.karthik@gene.com

 

Name: Kevin Solomon

Affiliation: Purdue University

Email: kvs@purdue.edu

 

Session description:

Microbial hosts are versatile chemical factories used for production of biopharmaceuticals, biofuels, bulk chemicals, and added value/specialty chemicals. These hosts are increasingly supplanted with non-model hosts such as algae, mycelial fungi, and photosynthetic microbes whose unique metabolism and physiology offer superior, robust performance under demanding industrial conditions. Driving the development of these processes are a wealth of new tools and approaches in systems biology, synthetic biology, metabolic engineering, next generation sequencing, and other enabling -omics technologies, which have improved our understanding and ability to engineer these microbial and non-model hosts. This session will focus on the interplay between the micro-scale (host engineering, protein expression, metabolic pathway analysis, and -omics characterization) and the macro-scale (fermentation strategy, process parameter optimization and quality control). We invite abstracts ranging from molecular and genetic tool development to global pathway engineering and process development for both endogenous and novel products. We also welcome efforts to accelerate design-build-test loops by systematizing workflows to enable better designs through cell-free systems, machine learning and other approaches, from both industrial and academic contributors. 

 

 

Session: Metabolic Engineering and Synthetic Biology

Session chairs:

Name: Jacob Latone

Affiliation: DuPont

Email: jacob.latone@dupont.com

 

Name: Tom Mansell

Affiliation: Iowa State

Email: Mansell@iastate.edu

 

Session description:

Biotechnology and its associated disciplines are the focal point for the design and construction of efficient cell factories for robust production of desired chemicals and biological products. Metabolic engineering aims to develop methods and concepts to analyze and engineer cell factories, while synthetic biology concentrates on the design and construction of non-native biological systems. The synergy between these two distinct yet complementary approaches holds great promise to further advance the manufacturing of biotechnological products. The topics of this session include, but may not be limited to, synthetic biology tools, metabolic pathway engineering, design and engineering of whole cell biocatalysts, and other biological networks for different market applications such as fuels, chemicals, pharmaceutical products, etc.

 

Session: Systems Biology and Omics Applications

Session chairs:

Name: Huong Le

Affiliation: Amgen

Email: huongl@amgen.com

 

Name: Nathan Lewis

Affiliation: University of California, San Diego

Email: n4lewis@ucsd.edu

 

Session description:

Living systems are dynamic and complex, and their behavior may be hard to predict from the properties of individual components. Systems biology focuses on the study of biological entities as a whole. Such studies aim to understand a defined system by comprehensively measuring its components, analyzing them in cellular pathways, and accounting for their functions using computational modeling, followed by perturbation, and manipulation of its elements. The quantitative analyses of interactions between components are applied to study these biological systems ranging from molecules and cells to organisms or entire species. Recent technological advances have improved quantification of the intracellular components and their interactions. This session will focus on recent progress in the development and utilization of cutting-edge tools and the application of integrated methodologies (both experimental and computational) to elucidate or exploit the internal mechanisms of a biological system in the context of observed phenotypes. Areas of interest include the development and application of individual or combined -omic analysis, biological network models, metabolic flux analysis, metabolic pathway simulations, protein or genome engineering based on systems-level understanding, etc. This session will highlight the insights and opportunities provided by these tools to drive biological systems to new levels of performance.

 

 

Session: Engineering Natural Products Biosynthesis

Session chairs: 

Name: Janice Wee

Affiliation: TerraVia

Email: jwee@terravia.com

 

Name: Yanran Li

Affiliation: University of California, Riverside

Email: yanranucla@gmail.com

 

Session description:

Today natural products remain an important source of biopharmaceuticals, biochemicals, and biofuels. Advances in bioinformatics-driven gene discovery, protein engineering, and metabolic engineering have continued to stimulate the discovery of complex small molecules with new scaffolds and functionalities and widened the opportunities for natural products to be produced through alternative means for commercial markets. This session will focus on the discovery of novel natural products through combinatorial biosynthesis, as well as the development and optimization of native or heterologous host systems for the industrial production of high-value natural products.