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Cambridge Healthtech Institute’s 22nd Annual

Recombinant Protein Expression and Production
( 組み換えタンパク質の発現と製造 )

Enhancing Expression, Performance, and Process

1月21日~22日

Part of the Biotherapeutic Expression & Production pipeline

Great strides have been made in the expression, production, and purification of biotherapeutics. However, hurdles remain to improving the quantity and quality of the efficient expression and production of these valuable biomolecules while minimizing time and cost. There is a greater demand for higher-throughput expression and purification, as well as more flexible expression platforms. Unfortunately, there is no “universal” production system which can guarantee high yields of recombinant protein, particularly as every biomolecule causes issues in terms of its own expression. Cambridge Healthtech Institute’s 22nd Annual Recombinant Protein Expression and Production conference explores the newest data and innovations relating to the best choices in hosts/systems, as well as ways to “rescue” existing systems and make them work more effectively to produce the quality and quantity of the desired biotherapeutic.

Final Agenda

1月21日(火)

1:00 pm Registration

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing

独自バイオプロダクトの効果的な発現と製造

2:00 Chairperson’s Opening Remarks

Henry Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific

 

KEYNOTE PRESENTATION

2:05 Gene Editing and Robotics Solve Upstream and Downstream Problems in HIV Vaccine Manufacturing in CHO Cells

Phillip Berman, PhD, Distinguished Research Professor, Biomolecular Engineering, University of California, Santa Cruz

The envelope protein, gp120, is a major component of vaccines designed to prevent HIV infection. However, production of gp120 in CHO has been challenging due to low expression, a complex glycosylation structure, and sensitivity to proteolysis. We have used gene editing of the MGAT1 and C1s genes and robotic selection to solve all three problems while at the same time improving the structure of glycan dependent epitopes recognized by monoclonal antibodies.

2:45 Recombinant HIV-1 Envelope Glycoprotein Trimers for Vaccine Development

Richard Wyatt, PhD, Professor, Immunology and Microbiology, Scripps Research Institute

3:15 Presentation to be Announced

 

3:30 Microbial Secretion of Complex Biotherapeutic Proteins by ESETEC® - Case Study with Akari Therapeutics

Dietrich_ArndtArndt Dietrich, PhD, Senior Expert DSP Development, BioProcess Development, Wacker Biotech GmbH

The innovative and highly efficient E. coli expression system ESETEC® enables the secretion of native recombinant proteins into the fermentation broth at high titer, thereby greatly simplifying the purification processes. This has recently been demonstrated in collaboration with Akari Therapeutics, a Biotech company focused on development anti-inflammatory Biopharmaceuticals.

3:45 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 Engineering Cells for Heparin and Heparan Sulfate Production

Glass_CharlesCharles Glass, PhD, President and CSO, TEGA Therapeutics, Inc.

Heparin and heparan sulfate (HS) are polysaccharide chains that serve as cofactors for specific protein binding and therefore have potential therapeutic qualities as drugs or drug targets. Protein binding specificity is determined by sulfate modifications along the polysaccharide backbone, which are cell type specific and which can be engineered through genes in the heparin/HS biosynthetic pathway. Through cell engineering, TEGA is testing a library of heparin/HS compositions for therapeutic applications.

5:00 Scalable Production and Purification of Single-Stranded DNA for Therapeutic Nucleic Acid Delivery

Bathe_MarkMark Bathe, PhD, Associate Professor, Biological Engineering, Massachusetts Institute of Technology

Viral-like structured DNA and RNA assemblies, also known as DNA or RNA origami, offer the ability to co-formulate gene-length single-stranded DNA or RNA with CRISPR-RNPs, siRNAs, or ASOs, with integration of active cellular targeting and uptake moieties including sugars and peptides. Scalable bacterial production of custom length and sequence single-stranded DNA will be presented together with co-formulation of siRNA and CRISPR therapeutics with pre-clinical in vivo biodistribution and toxicity studies in mouse that offer a platform for next-generation nucleic acid therapeutic delivery.

5:30 Close of Day

5:30 - 5:45 Short Course Registration

5:45 - 8:45 Recommended Dinner Short Course*

SC6: Assembling an Effective Toolbox of Expression Systems to Support Your Drug Discovery Efforts

Instructors:
Richard Altman, Field Application Scientist, Protein Expression, Biosciences Division, Life Sciences Solutions Group, Thermo Fisher Scientific
Henry Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, PhD, Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research

 

*Separate registration required

1月22日(水)

7:45 am Registration and Morning Coffee

組み換えタンパク質の効果的な発現と製造

8:15 Chairperson’s Remarks

Phillip Berman, PhD, Distinguished Research Professor, Biomolecular Engineering, University of California, Santa Cruz

FEATURED PRESENTATION

8:20 Analysis of the Immunoglobulin G (IgG) Secretion Efficiency in Recombinant Chinese Hamster Ovary (CHO) Cells

Omasa_TakeshiTakeshi Omasa, PhD, Professor, Department of Material and Life Science, Graduate School of Engineering, Osaka University

In this study, a CHO cell line producing IgG1, which was genetically fused with fluorescent proteins, was established to directly analyze intracellular secretion. The relationship between the amount of intracellular and secreted IgG was analyzed. An immunofluorescent microscopy study showed that the established clones could be used to analyze the intracellular secretion bottleneck. Also, to improve the production of various therapeutic antibodies, we analyzed the protein secretion process in CHO cells producing the DTE IgG infliximab.

8:50 Novel Prediction Tool to Evaluate Synonymous Changes in Recombinant Therapeutic Proteins

Katagiri_NobukoNobuko Katagiri, PhD, Research Biologist, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER, FDA

Accurate prediction of phenotype based on the genotype is a fundamental goal in the medical genetics field. In silico tools to predict the effects of single missense variations are available from various sources. On the contrary, prediction of synonymous or multiple mutations remains highly challenging and yet valuable because these sequence changes are often seen in recombinant therapeutics. Our recent efforts towards improvement of such tools will be discussed. 

Validogen 9:20 Boosting VHH Expression Using UNLOCK PICHIA

Dib_IskandarIskandar Dib, Principal Scientist Process Development & Analytics, VALIDOGEN GmbH

VHHs, single-domain antibodies derived from camelid species represent the third generation of antibodies and are currently developed for an increasing number of different applications.

Efficient production of VHHs is enabled by VALIDOGEN’s yield-enhancing protein production toolbox known as UNLOCK PICHIA comprising a broad diversity of molecular tools and expression strategies for Pichia. We demonstrate significant enhancement of VHH expression by a set of helper factors acting along the way from transcription to secretion.


9:50 Coffee Break in the Exhibit Hall with Poster Viewing

10:35 Recombinant Protein Production in Research at Novo Nordisk

Brian Vandahl, PhD, Corporate Vice President, Recombinant Technologies, Global Research Technologies, Novo Nordisk A/S

A discussion of challenges and opportunities in recombinant protein production seen from a Novo Nordisk Research perspective.

11:05 Recent Advances in Screening and Production of Recombinant Proteins in Plants and Plant Cells

Buyel_JohannesJohannes Buyel, Dr rer nat, Dr-Ing, Head, Bioprocess Engineering, Fraunhofer Institute for Molecular Biology and Applied Ecology IME

High-throughput screening systems in 96-well plate format have been developed for plant-based expression. This can facilitate the production of novel and innovative protein biopharmaceuticals that can otherwise be difficult to express in mammalian or microbial hosts due to toxicity or complexity respectively. We also discuss the translation from screening to production for plant-based systems.

11:35 Antibody Production Using an Inducible CHO Cell Line: Process Development and Intensification

Henry_OlivierOlivier Henry, PhD, Associate Professor, Chemical Engineering, Polytechnique Montréal

Mammalian-inducible expression systems are increasingly available and offer an attractive platform to produce recombinant proteins. Inducible systems allow to uncouple the growth and the production phases. We have conducted process development for a cumate-inducible GS-CHO cell line expressing rituximab. We have explored the use of fed-batch and continuous perfusion strategies applied during the pre-induction phase to enhance process performance in terms of product yield and quality.

12:05 pm Session Break

thermofisherscientific_no_tagline 12:15 LUNCHEON PRESENTATION I: Optimized Protein and Virus Production in the Expi Expression Systems

Jonathan Zmuda, PhD, Cell Bio R&D, Thermo Fisher

 

12:45 Luncheon Presentation II (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break


1:45 PLENARY KEYNOTE PANEL

R&D CHALLENGES IN AN ERA OF INNOVATION

 

The PepTalk Plenary Keynote Panel convenes a group of leading scientists working across novel therapeutic modalities and R&D technologies to explore the many challenges associated with discovering, developing, and advancing today’s novel biotherapeutics. The Panel, via a highly interactive format, encourages discussion among both the panelists and the audience members. Please come prepared with your questions and ideas for this spirited discussion.

  • Advances and challenges in expression and production for novel modalities
  • Implementing next-generation informatics: data collection, standardization, analysis, ML/AI, and considerations for IP landscape and protection
  • Implementing R&D and production capacity for gene and cell therapies – where are we heading?
  • Modality-specific challenges: multi-specifics for cancer, improving the ADC therapeutic window, improved safety and pharmacology, novel delivery/targeting
  • Preclinical and clinical development of drug combinations with focus in IO: How do we select the right combination dose so we can accelerate clinical development?

Moderator:

Mohammad Tabrizi, PhD, Senior Director, Pharmacology, Ascendis Pharma A/S

 

 

PANELISTS

Edward Kraft, PhD, Senior Scientific Manager, Biomolecular Resources, Genentech

 

 

Ilya Shestopalov, PhD, Associate Director, Cell Analytics, bluebird bio

 

 

David E. Szymkowski, PhD, Vice President, Cell Biology, Xencor, Inc.

 

 

Alayna George Thompson, PhD, Senior Scientist I, Drug Discovery Science & Technology, AbbVie

 

 

3:05 Refreshment Break in the Exhibit Hall with Poster Viewing

発現困難なタンパク質の効果的な発現と製造

4:00 Chairperson’s Remarks

Johannes Buyel, Dr. rer. nat., Dr-Ing, Head, Bioprocess Engineering, Fraunhofer Institute for Molecular Biology and Applied Ecology IME

4:05 Statistical Design for Effector Function Engineering of Hexameric Fc Domains

Shirley Peters, PhD, Principal Scientist, UCB

We used antibody engineering and recombinant expression to produce Fc with controlled hexa-valency, “Fc-multimer”. Fc-multimer may have clinical potential as a recombinant protein replacement of intravenous immunoglobulin (IVIG) for the treatment of auto-inflammatory immune disorders. Fc-multimer engages with FcgR’s on multiple cell types and was engineered to maximize potency whilst minimizing potential safety concerns. We used a statistical design approach (‘Design of Experiments’) to explore the two effector function extremes defined by IgG1 and IgG4.

4:35 Which Sugar Do You Want: Tailormade Glycosylation of Therapeutic Proteins

Voldborg_BjornBjørn Voldborg, MSc, Director, CHO Cell Line Development, The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark


5:05 High-Level Expression of Thermostable Human Cannabinoid Receptor CB2 in Expi293 Cells for Biophysical Studies

Yeliseev_AlexeiAlexei Yeliseev, PhD, Staff Scientist, Group Leader, LMBB, National Institute on Alcohol Abuse and Alcoholism, National Institute of Health

G protein-coupled receptors (GPCR) comprise a large class of integral membrane proteins important for pharmaceutical drug development. We expressed a full-length cannabinoid receptor CB2 in suspension expi293 HEK cells and purified and solubilized it in a Façade-TEG detergent. The receptor was homogenous and did not lose its functional activity even after several hours of exposure to elevated temperature. We propose that post-translational modifications of CB2 are essential for its structural stability.

5:35 Two Cytoplasmic Ubiquitin E3 Ligases and an ER Protease Mediate ER-Associated Degradation of Unfolded Antibody Heavy Chains

Tang_DanmingTang Danming, PhD, Technical Development Scientist, Cell Culture, Genentech

Accumulation of unfolded antibody chains in the ER triggers ER stress that may lead to reduced productivity in therapeutic antibody manufacturing processes. We identified UBR4 and UBR5 as ubiquitin E3 ligases involved in HC ER-associated degradation, while an ER protease PDIA3 cleaves ubiquitinated-HC molecules to accelerate HC dislocation. Proteins characterized in this proteolysis/proteasome-dependent pathway of unfolded antibody HC degradation may be novel targets for CHO cell engineering.

6:05 - 7:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Recombinant Protein Expression and Production Conference

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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