Overview

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Date: Sunday, September 22, 2019
17:00-18:00
Registration
Foyer
18:00-20:00
Welcome reception

A get together with plenty of finger food to replace dinner

Date: Monday, September 23, 2019
07:30-08:30
Breakfast
Rose Island
08:30-09:00
Introductory Remarks

Carlos Bosques

Grand Ballroom
09:00-10:10 Big Data in Cell line and Process Design and Protein Production I

In vivo, animal cells have the capacity to produce and secrete proteins at an order of magnitude higher than seen in leading clones in industrial bioprocesses. Furthermore, each protein has its set of post-translational modifications that can be relevant to its function. Novel technologies have emerged that are elucidating the mechanisms underlying protein secretion and identifying approaches to increase cell productivity, boost protein yields in bioprocessing, and control product quality. These include high throughput screens, omics data, systems biology models and machine learning. Speakers in this session will present work on technologies enabling the development of novel strategies for enhancing and controlling protein production through the generation and analysis of biological big data.

Nathan Lewis, Claes Gustafsson , Co-Chairs,
Grand Ballroom
10:10-10:40
Coffee Break
Exhibition Room
10:40-11:30 Big Data in Cell line and Process Design and Protein Production II

In vivo, animal cells have the capacity to produce and secrete proteins at an order of magnitude higher than seen in leading clones in industrial bioprocesses. Furthermore, each protein has its set of post-translational modifications that can be relevant to its function. Novel technologies have emerged that are elucidating the mechanisms underlying protein secretion and identifying approaches to increase cell productivity, boost protein yields in bioprocessing, and control product quality. These include high throughput screens, omics data, systems biology models and machine learning. Speakers in this session will present work on technologies enabling the development of novel strategies for enhancing and controlling protein production through the generation and analysis of biological big data.

Claes Gustafsson Nathan Lewis , Co-Chairs,
Grand Ballroom
11:30-12:30
Peace Keynote Lecture

Dr. Mathias Uhlen

The Human Secretome Project – generation of all human secreted proteins in mammalian cell cultures

Mathias Uhlen
Science for Life Lab, Karolinska Institutet and Royal Institute of Technology, Stockholm, Sweden

The Human Protein Atlas (HPA) is an international program with the aim to map of all the human proteins in cells, tissues and organs using integration of various omics technologies, including genomics, transcriptomics, antibody-based imaging, mass spectrometry-based proteomics and systems biology. The current version (www.proteinatlas.org) consists of three separate parts, each focusing on a particular aspect of the genome-wide analysis of the human proteins; (1) the Tissue Atlas showing the distribution of the proteins across all major tissues and organs in the human body, (2) the Cell Atlas showing the subcellular localization of proteins in single cells, and (3) Pathology Atlas showing the impact of protein levels for survival of patients with cancer. This year we plan to also launch a new Brain and a new Blood Atlas. All the data in the knowledge resource is open access to allow scientists both in academia and industry to freely access the data for exploration of the human proteome. We have used this resource to launch various efforts in the field of Precision Medicine. We have also launched a Human Secretome Project to produce in mammalian cell cultures all human secreted proteins (4). The progress of this project will be discussed and the results from phenotypic screening of this resource will be presented.
1. Uhlen et al (2015) Science 347: 1260419
2. Thul et al (2017) Science 356 (6340): eaal3321
3. Uhlen et al (2017) Science 357 (6352): eaan2507
4. Uhlen et al (2018) BioRxiv, https://doi.org/10.1101/465815

Grand Ballroom
12:30-14:00
Lunch
14:00-15:30 Protein Quality Control I

Recombinant proteins produced from animal cell culture are characterized by their high degree of complexity and the selected expression system as well as process conditions have a significant impact on protein quality. For this session we invite presentations that cover novel approaches to evaluate the biological, chemical and physical properties of a product. In-depth bio-analytical characterization plays a critical role in establishing comparability of a product following process, scale and site changes. This session will focus on testing strategies and case studies high-lighting the pivotal role of analytical characterization in development, licensure, and post-licensure life cycle management.

Manon Cox, Chair,
Grand Ballroom
15:30-16:00
Coffee Break
Exhibition Room
16:00-16:35 Protein Quality Control II

Recombinant proteins produced from animal cell culture are characterized by their high degree of complexity and the selected expression system as well as process conditions have a significant impact on protein quality. For this session we invite presentations that cover novel approaches to evaluate the biological, chemical and physical properties of a product. In-depth bio-analytical characterization plays a critical role in establishing comparability of a product following process, scale and site changes. This session will focus on testing strategies and case studies high-lighting the pivotal role of analytical characterization in development, licensure, and post-licensure life cycle management.

Manon Cox, Chair,
Grand Ballroom
16:40-19:00 Poster Session I (Odd numbered Posters) & Cocktail

Exhibition room
19:30-20:30
Dinner at Gurney's
Rose Island
Date: Tuesday, September 24, 2019
07:30-08:30
Breakfast
Rose Island
08:30-09:50 Expression Systems I

CHO cells are the predominant host for the industrial manufacturing of recombinant protein therapeutics. However, the R&D environment often moves beyond the transient and stable mammalian expression systems to utilize a multitude of expression platforms including in-vitro translation, bacteria, plants, fungi, insect cells, and yeast. The choice of expression system selected can be influenced by the class of recombinant proteins such as multi-span membrane receptors, multi-chain bispecifics, and other “difficult-to-express” candidates. This session will cover the expanding repertoire of expression platforms used for producing recombinant proteins including the use of synthetic biology approaches and powerful gene editing technologies for tailoring host capabilities to match specific process and product quality attributes important for biological functions. Relevant topics will include innovative CHO modalities (transient, stable, inducible, transposases, random and targeted plasmid integration) and other mammalian and non-mammalian expression systems.

Yves Durocher, René Hubert, Co-Chairs,
Grand Ballroom
09:50-10:20
Coffee Break
Exhibition Room
10:20-11:00 Expression Systems II

CHO cells are the predominant host for the industrial manufacturing of recombinant protein therapeutics. However, the R&D environment often moves beyond the transient and stable mammalian expression systems to utilize a multitude of expression platforms including in-vitro translation, bacteria, plants, fungi, insect cells, and yeast. The choice of expression system selected can be influenced by the class of recombinant proteins such as multi-span membrane receptors, multi-chain bispecifics, and other “difficult-to-express” candidates. This session will cover the expanding repertoire of expression platforms used for producing recombinant proteins including the use of synthetic biology approaches and powerful gene editing technologies for tailoring host capabilities to match specific process and product quality attributes important for biological functions. Relevant topics will include innovative CHO modalities (transient, stable, inducible, transposases, random and targeted plasmid integration) and other mammalian and non-mammalian expression systems.

Yves Durocher, René Hubert, Co-Chairs,
Grand Ballroom
11:10-11:05
Short Break
Exhibition Room
11:05-13:05 Industrial Workshops

Industrial Workshops

Carlos Bosques, Chair,
Grand Ballroom
13:00-14:00
Lunch
14:30-18:00
Tours
20:00-22:00
Dinner in local restaurant
Date: Wednesday, September 25, 2019
07:30-08:30
Breakfast
Rose Island
08:30-09:40 Cell Engineering 1

The production of complex biopharmaceutical proteins primarily uses mammalian cell expression systems due to the ability of these systems to produce and secrete correctly folded, functionally active recombinant proteins. Advances in synthetic biology tools for cell engineering have expedited cell line development for the production of high-quality biologics. This session will focus on new or novel methods and emerging technologies to modify or select cells to develop and establish recombinant cell lines. Topics of interest may include vector design and clone/host selection, codon optimization, synthetic biology approaches, genome engineering and editing tools, recombination mediated integration, cell redesign, non-coding RNAs, inducible systems, and cell line stability.

Mark Smales , Peter Tessier, Co-Chairs,
Grand Ballroom
09:40-10:10
Coffee Break
Exhibition Room
10:10-11:05 Cell Engineering 2

The production of complex biopharmaceutical proteins primarily uses mammalian cell expression systems due to the ability of these systems to produce and secrete correctly folded, functionally active recombinant proteins. Advances in synthetic biology tools for cell engineering have expedited cell line development for the production of high-quality biologics. This session will focus on new or novel methods and emerging technologies to modify or select cells to develop and establish recombinant cell lines. Topics of interest may include vector design and clone/host selection, codon optimization, synthetic biology approaches, genome engineering and editing tools, recombination mediated integration, cell redesign, non-coding RNAs, inducible systems, and cell line stability.

Mark Smales , Peter Tessier, Co-Chairs,
Grand Ballroom
11:10-12:10
Peace Keynote Lecture

Kathrin Jansen

Maternal immunization- An update where we stand with protecting neonates and young infants from infectious diseases

Kathrin U Jansen, SVP and Head of Vaccine Research and Development, Pfizer Inc.

Maternal immunization to protect the most vulnerable in many countries- neonates and young infants- has become more mainstream and widely accepted globally. Stunning public health results to address neonatal and young infant disease and mortality caused by tetanus, pertussis and influenza have been achieved by vaccinating pregnant mothers with vaccines that were never licensed for use in pregnancy 1-4. In fact, maternal and neonatal tetanus was a common life-threating infection resulting from unclean delivery and umbilical cord care practices leading to at least 900,000 neonatal deaths in the 1980s. Today the common implementation of maternal immunization in LMICs with tetanus vaccines for example has reduced neonatal tetanus mortality by ~ 92% worldwide5. Very importantly, maternal immunization has also been proven to be safe6 and routine maternal immunization with influenza and TdaP vaccines are currently recommended in many countries. Success stories like these have encouraged vaccine companies to embark on the development of maternal vaccines and regulatory agencies have charted a pathway for the potential licensure of such vaccines. We will discuss the status of 2 maternal vaccines in development, a bacterial vaccine to protect against Group B streptococcus (GBS6) and a viral vaccine against Respiratory Syncytial Virus (RSV). GBS6 is a six-valent polysaccharide conjugate vaccine composed of polysaccharide capsule of the six major GBS serotypes conjugated to the carrier protein CRM197. The GBS6 vaccine was highly effective in preclinical maternal immunization models. The initial Phase 1/2 data are now available and will be presented. The RSV vaccine is based on the stabilized prefusion F antigen that has been shown to elicit superior RSV neutralizing antibody responses compared to a licensed monoclonal antibody and postfusion F constructs (unpublished observation). The data demonstrating that the prefusion F vaccine candidate elicits strong protection in animal models will be presented.

1. Zaman K, et al. N Engl J Med 2008; 359: 1555-64.
2. Madhi SA, et al. N Engl J Med 2014; 371: 918-31.
3. Amirthalingam G, et al. Lancet 2014;384:1521–8.
4. Dabrera G, et al. Clin Infect Dis 2015; 60: 333-7.
5. Healy CM. Clin Obstet Gynecol. 2012 Jun; 55(2):474-86.
6. WHO 2014, Safety of immunization during pregnancy-a review of the evidence.

Grand Ballroom
12:20-13:50
Lunch
14:00-15:30 Protein Engineering 1

The engineering and production of proteins are crucial components of the biopharmaceutical industry. Over the last decades, innovative protein engineering have led to the development of multiple classes of therapeutic proteins including antibodies, bispecifics, fusion proteins, and many others. Protein engineering applications include both rational design and directed evolution to generate proteins with desired physicochemical or functional characteristics. This session will focus on recent progress and examples on the field of protein engineering. For example, this session will cover discussions on: novel protein design, antibody design to create novel antibodies or antibodies with optimized Fab or Fc-mediated functions, optimization of protein stability, generation of antibody-drug conjugates (ADCs), glycoengeeniring to optimize protein structure or function, directed protein evolution, etc.

Carlos Bosques, Traian Sulea, Co-Chairs,
Grand Ballroom
15:30-16:00
Coffee Break
Exhibition Room
16:00-16:45 Protein Engineering 2

The engineering and production of proteins are crucial components of the biopharmaceutical industry. Over the last decades, innovative protein engineering have led to the development of multiple classes of therapeutic proteins including antibodies, bispecifics, fusion proteins, and many others. Protein engineering applications include both rational design and directed evolution to generate proteins with desired physicochemical or functional characteristics. This session will focus on recent progress and examples on the field of protein engineering. For example, this session will cover discussions on: novel protein design, antibody design to create novel antibodies or antibodies with optimized Fab or Fc-mediated functions, optimization of protein stability, generation of antibody-drug conjugates (ADCs), glycoengeeniring to optimize protein structure or function, directed protein evolution, etc.

Carlos Bosques, Traian Sulea, Co-Chairs,
Grand Ballroom
16:45-17:30
General Assembly PEIS
Grand Ballroom
17:30-19:00 Poster Session II (Even numbered Posters) & Cocktail

Exhibition Room
19:30-24:00
Gala Dinner
Date: Thursday, September 26, 2019
07:30-08:30
Breakfast
Rose Island
08:30-09:40 Bio-Processing 1 Sponsored by Evonik

Production of efficacious and safe biologicals using animal cell culture continues to pose significant challenges in upstream and downstream processing. Enormous improvements in productivity have been made over the past decade throughout the process resulting in protein yields exceeding grams per liter. This session aims to discuss the latest development in process optimization for various protein expression platforms including media optimization (towards defined media), feed-strategies, continuous processing, with an emphasis on Quality by Design. Abstracts describing recombinant protein production strategies specifically aimed to improve productivity and ease of manufacturing are welcome.

Zahia Hannas, Nicolas Seve, Co-Chairs,
Grand Ballroom
09:40-10:10
Coffee Break
Exhibition Room
10:10-11:30 Bio-Processing 2 Sponsored by Evonik

Production of efficacious and safe biologicals using animal cell culture continues to pose significant challenges in upstream and downstream processing. Enormous improvements in productivity have been made over the past decade throughout the process resulting in protein yields exceeding grams per liter. This session aims to discuss the latest development in process optimization for various protein expression platforms including media optimization (towards defined media), feed-strategies, continuous processing, with an emphasis on Quality by Design. Abstracts describing recombinant protein production strategies specifically aimed to improve productivity and ease of manufacturing are welcome.

Zahia Hannas, Nicolas Seve, Co-Chairs,
Grand Ballroom
11:30
AWARDS AND CLOSE
Grand Ballroom