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| Sunday September 16 |
PM |
18:00 - 21:00 |
Keynote Speaker - Welcome reception
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| Monday September 17 |
AM |
09:00 - 10:45 |
Session 1: Expression System Design
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10:45 - 11:15 |
Coffee break |
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|
11:15 - 12:30 |
Session 1: Expression System Design
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|
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13:00 |
lunch |
|
PM |
14:00 - 16:15 |
Session II: Gene Delivery |
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16:15 - 16:45 |
Coffee break |
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16:45 - 18:00 |
Short Talks
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18:00 -18:30 |
Coffee break |
|
|
19:15 - 20:00 |
Poster Session - Cocktail Reception |
| Tuesday September 18 |
AM |
08:30 - 10:15 |
Session III: Cell Engineering Session |
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10:15 - 10:45 |
Coffee break |
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10:45 - 11:45 |
Session III: Cell Engineering Session |
|
PM |
11:45 - 13:00 |
Industrial Workshops |
|
|
11:45 - 12:15 |
SAFC Bioscience |
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12:15 - 12:45 |
Invitrogen |
|
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19:15 - 20:00 |
Poster Session - Cocktail Reception
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| Wednesday September 19 |
AM |
09:00 - 12:00 |
Session IV: Post-translational modifications/product integrity
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|
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10:45 - 11:15 |
Coffee break |
|
|
11:15 - 11:45 |
Session IV: Post-translational modifications/product integrity
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|
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11:45 - 13:00 |
Industrial Workshops |
|
|
11:45 - 12:15 |
Kemp Biotechnologies |
|
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12:15 - 12:45 |
Wave Biotech |
|
PM |
14:30 - 16:15 |
Session V Integrated process development
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|
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16:15 - 16:45 |
Coffee break |
|
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16:45 - 18:00 |
PEIS General Assembly |
|
|
20:00 |
Gala diner |
| Thursday September 20 |
AM |
08:30 - 11:30 |
Session VI: Viral Vaccines |
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|
Preliminary partial program
|
| Keynote Speaker |
| Jorge Kalil |
Universidade de Sao Paulo |
Sao Paulo |
Brasil |
|
| *Towards a vaccine to prevent rheumatic fever* |
|
MONDAY, SEPTEMBER 17
|
Session 1: Expression System Design
|
9:00 - 12:00
|
| Chair: Kenneth Lundstrom |
Flamel Technologies |
Vénissieux |
France |
|
| Co-chair: Mike Betenbaugh |
John Hopkins University |
Baltimore |
USA |
|
Expression system design involves the optimization of expression vectors at the molecular level to bring about desirable downstream effects at the cellular level. The technologies presented here are targeted to the engineering of mammalian or insect cell expression vectors. The molecular basis of stable expression will be discussed as one of the key aspects of ensuring high quality protein production and reproducibility. Translational control is also important for further improvement in the enhancement of productivity. Furthermore, the choice of promoter has a significant effect on protein expression. The question concerns not only the strength of promoter activity as for many expression systems cell type specific and time-dependent (early and late) promoters exist. Closely related to promoters is the issue of generating inducible expression systems. The advantage of this approach is that expression can be turned on and off in a controlled manner to maximize protein production. Additionally, the session will deal with site-specific integration and insulators. In the context of engineering stable cell lines it has become evident that the chromosomal integration site plays an important role for construct stability and expression levels. Introduction of insulator sequences or matrix attachment regions have a strong influence on stability and protein production. |
|
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|
|
|
| T1.1: Alan Dickson |
University of Manchester |
Manchester |
UK |
|
| "Characterisation of molecular mechanisms that determine stability/instability of recombinant gene expression in NS0 myeloma cell lines" |
| T1.2: Beate Stern |
UniTargetingResearch AS |
|
Norway |
|
| UTRtech as a means to improve mRNA translatability and the productivity of mammalian cells |
| T1.3: Jackie Sheng |
Amgen |
|
USA |
|
| The use of expression vector engineering for improved genomic stability and enhanced protein production |
| T1.4: Nicolas Mermod |
EPFL |
|
Switzeland |
| "High-level transgene integration and expression in mammalian cells using MAR elements" |
| T1.5: Eelco Docter |
AstraZenica |
|
|
|
| "Comparison of different mammalian expression vector for transient transfection in HEK EBNA cells |
| T1.6 |
|
|
|
|
| Session II: Gene Delivery |
|
|
14:30 - 16:15 |
| Chair: Reingard Grabherr |
Univ.f.Bodenkultur Wien |
Vienna |
|
Austria |
| Co-chair: Tom Kost |
GlaxoSmithKline |
Research Triangle Park |
USA |
| The development of vectors and methods that are capable of efficient gene delivery is crucial to the success of recombinant protein production, studies of cellular mechanisms, assay development and gene therapy. This session will include presentations that highlight advances in the development and application of adeno-associated virus (AAV), baculovirus and adenovirus vector gene delivery systems as well as improvements in non-viral gene delivery systems. |
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|
|
|
| T2.1: Boro Dropulic |
Lentigen Corporation |
|
Baltimore |
USA |
| The Generation of Protein Expressing Cell Lines using Lentiviral Vector Mediated Gene Delivery |
| T2.2: Jude Samulski |
University of North Carolina |
Chapel Hill |
|
USA |
| Gene Therapy and Muscular Dystrophy: Results from Phase I clinical trial where do we go from here |
| T2.3: Raj Haldankar |
Amgen |
Thousand Oaks |
USA |
| Transient Recombinant Antibody Expression in HEK 293EBNA cells at greater than 100 mg/L |
| T2.4: Wang Shu |
The Institute of Bioengineering and Nanotechnology |
Singapore |
| Baculoviral Vectors for Gene Transfer into Human Embryonic Stem Cells |
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| Short Talks |
|
|
|
16:45 -19:00 |
| Chair: Kenneth Lundstrom |
Flamel Technologies |
Vénissieux |
France |
|
The topics of the Short Talk Session is a good indication of the diversity of topics presented at the PEACe meeting. The oral presentations were selected by the Scientific Organizing Committee from submitted abstracts with the following intentions:
o Enhance active participation of delegates
o Provide the opportunity for younger scientists to present their data
o Improve information exchange in a cross-field manner
The session will include presentation on cell engineering, vector engineering, improvement of cell culture conditions and enhanced recombinant protein production. Drosophila melanogaster S2 cells were used for enhanced recombinant production of Rabies virus glycoprotein through the control of culture conditions (Swiech, Brazil). Furthermore, the influence of oxygen concentration on the performance of S2 cells will be described (Batista, Brazil). Cell engineering by introduction of anti-apoptotic genes in relation to production will also be presented (Nivitchanyong, USA). A genomics approach for the identification of endogenous CHO promoter elements will be discussed (Pontiller, Austria). Additionally, Dr. Puchacz (USA) will present the use of the UCOE (Ubiquitous Chromatin Opening Elements) gene expression technology for protein production. Engineering of CHO-K1 cells to improve Baculovirus-based expression in mammalian cells will also be described (Clay, USA). Moreover, the session will contain talks on enhancing antibody expression in CHO cells by using chromatin remodeling elements (Saunders, UK) and the Gene Stripper system for the FACS selection of protein producing clones (Zang-Gander, USA).
|
| Camilo Calderòn |
Universidad Arturo Prat |
|
|
Brazil |
| "Enhanced production of recombinant rabies virus glycoprotein (rvgp) by drosophila melanogaster s2 cells through control of culture conditions" |
| Ângela Moraes |
State University of Campinas |
|
Brazil |
| "Influence of dissolved oxygen concentration on recombinant s2 cells performance" |
| Shilpa Shroff |
BioMarin Pharmaceutical |
|
|
USA |
| "Application of anti-apoptosis genes for perfusion-mode production of recombinant proteins by CHO cells" |
| Jens Pontiller |
ACBT, IAM, |
Vienna |
|
Austria |
| "Identification of CHO endogenous promoter elements based on a genomic library approach" |
| Ela Puchacz |
Millipore Corporation |
|
|
USA |
| "Accelerated Method for Production of Recombinant Proteins using UCOE Gene Expression Technology" |
| William Clay |
GSK |
|
|
USA |
| "Engineering an improved CHO-K1 host cell line for BacMam-mediated protein expression and cell-based assay d"evelopment. |
| Fay Saunders |
UCB Celltech |
|
|
UK |
| "The use of chromatin remodelling elements to increase antibody expression in cho-k1 cells" |
| Josef Mittermaier |
Eugenex Biotechnologies |
|
|
Switzerland |
"GeneStripper: System for Selection of the Best"
|
TUESDAY, SEPTEMBER 18
|
| Session III: Cell Engineering Session |
|
8:30 -12:45 |
| Chair: Mark Smales |
University of Kent |
Canterbury |
|
U.K. |
| Co-chair: Andy Racher |
Lonza Biologics |
Slough Berkshire |
U.K. |
Cell engineering is considered as any manipulation that results in some change to the cell of interest. The subjects and topics within the area of cell engineering are wide, covering a diverse range of topics including, but not limited to, stem cell research, metabolic engineering, the up-regulation/knockdown(out) of target genes and proteins, the development of new cell lines and media, and many other topics besides. As suchcell engineering could be considered a seamless subject that transcends into many other areas, lying directly at the research interface between engineers, biological scientists, mathematicians and product manufacturing specialists. Perhaps a more encompassing description of cell engineering would therefore be the investigation manipulation,and enhancement of the biological processes that underpin cellular performance. This session intends to promote discussion of current leading edge research in this diverse area. |
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|
|
|
|
| T3.1: Ineke Braakman |
Utrecht University |
Utrech |
The Netherlands |
| Role of Calnexin & calreticulin Ero1 & PDI and Novel ER proteins in protein folding in the ER; ER expansion during B cell differentiation; Effects of ER stress on the proteome of mammalian cells |
| T3.2: Kim Stutzman- Engwall |
Pfizer Global Research & Development |
Groton |
USA |
| "Engineering a CHO Cell Line to Express a High Value Drug Target - Cholesteryl Ester Transfer Protein (CETP)" |
| T3.3: Linda M. Hendershot |
St. Jude Children's Research Hospital |
|
USA |
| Building an Antibody Factory: A Job for the Unfolded Protein Response |
| T3.4: Trevor N. Collingwood |
Sangamo BioSciences |
Richmond, |
CA |
USA |
| "Rapid Targeted Gene Knockout and Site-Specific Gene Integration using Zinc Finger Nucleases" |
| T3.5Joseph Shiloach |
NIH |
|
|
USA |
"Identifying genes that affect cell behavior and protein production using microarrays"
|
|
WEDNESDAY, SEPTEMBER 19
|
Session IV: Post-translational modifications/product integrity
|
|
9:00 -13:00 |
| Chair: Ana Maria Moro |
Instituto Butantan |
Sao Paolo |
Brazil |
|
| Co-chair: Mike Butler |
University of Manitoba |
Winnipeg |
Canada |
|
Many proteins depend on complex post-translational modifications (PTM) relating structure to appropriate functionality. PTM has influence on biological activity, half-life of the protein, its immunogenicity and stability. The choice of host cells for expression of recombinant therapeutic proteins is of utmost importance. Nowadays a lot of research is carried out trying to humanize other expression systems than mammalian cells, still considered the biological system of choice. Glycosylation is often very accurate and precise causing serious impact on product consistency. As many natural proteins present molecular heterogeneity and glycan isoforms, it can be a problem to understand the acceptable biological range. Other frequent PTM include amination, phosphorylation, carboxylation, hydroxylation, sulfation, folding, and pegylation. The regulatory authorities are raising the standards for demonstrating product consistency thus making process development and in-process control of great impact at industrial level. Endeavors for the development of sophisticated analytical tools have demonstrated the feasibility of ensuring consistent quality of products, synthesized as expected and not degraded by impurities or additives. To understand naturally occurring PTM, build biological systems capable of accomplishing PTM at acceptable levels, design and operate large-scale processes, and develop analytical tools to control PTM and protein integrity depend on multidisciplinary efforts with many interfaces. This session will present and discuss examples of PTM and product integrity both at development and industrial levels. |
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| T4.1: Nigel Jenkins |
Dublin City University |
Dublin |
|
Ireland |
| Post-Translational Modifications of Amino Acid Residues in Recombinant Proteins: Significance for Biopharmaceuticals |
| T4.2: Roy Jefferis |
Birmingham University |
Birmingham |
|
UK |
| The influence of glycosylation on antibody function: challenges and opportunities |
| T4.3: Mike Betenbaugh |
Johns Hopkins University |
|
|
USA |
| Glycosylational Processing in Animal Cells |
| T4.4: Rod Keck |
Genentech |
|
|
USA |
| Oligosaccharides: Impact on recombinant monoclonal antibody clearance |
| T4.5: Randal Kaufman |
University of Michigan |
Ann arbor |
|
USA |
| "Protein Folding in the Endoplasmic Reticulum and the Unfolded Protein Response" |
Session V Integrated process development
|
|
14:30 - 16:15 |
| Chair: Beth Augusto |
Instituto Butantan |
Sao Paolo |
|
Brazil |
| Co-chair: Konstatin Konstantinov |
Genzyne |
|
|
USA |
This session will highlight advances and challenges in accelerating cell culture process development and scale-up for clinical and commercial manufacturing of proteins as biopharmaceuticals. Topics for the session include enabling tools and technologies, including Process Analytical Technology (PAT), that stimulate real-time monitoring, process control and early product characterization, novel approaches and practices for rapid and efficient process development or characterization, such as scale-down, optimization, scale-up and improved integration with downstream processing. Industrial best practice examples to improve culture productivity, while ensuring product quality, are particularly welcome. |
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|
|
| T5.1: Octavio Ramirez |
UNAM |
Cuernavaca |
|
Mexico |
| Integrated process monitoring and development for the production of synthetic viral structures: from cell culture to purified metallic nanoparticles |
| T5.2: Ron Taticek |
Genentech |
San Francisco |
USA |
| Quality by Design & its Impact on Cell Culture Process Development |
| T5.3:Anne Bondgaard Tolstrup |
Symphogen A/S |
Denmark |
|
| One-pot production of recombinant human polyclonal antibody drug product |
| T5.4 |
|
|
|
|
THURSDAY, SEPTEMBBER 20
|
Session VI: Viral Vaccines
|
|
8:30 -11:45 |
| Chair: Amine Kamen |
Biotechnology Research Institute |
Montréal |
|
Canada |
| Co-Chair: Americo Craveiro |
Vallée |
|
|
Brazil |
Cell culture derived viral vaccines play an increasingly important role in current clinical approaches and recently a number of good new targets have been successfully evaluated. Also, there is a growing interest in the use of advanced technologies for efficient manufacturing. The session will include presentations on topics related to the development and production of viral vaccines, such as attenuated or inactivated influenza virus, sub-unit cancer vaccines and development strategies for emergent or emergency vaccines. This will include cell line and vector development based on new animal-cell based expression systems, improvement of viral vector design or safety. New analytical technologies related to the determination of viral titers, infectivity, safety and process robustness will be discussed as well as strategies for improved productivity and downstream processing. |
| T6.1: Carlos Augusto Pereira |
Instituto Butantan |
|
Sao Paolo |
Brasil |
| Synthesis of viruses and viral proteins by insect cells |
| T6.2: John C. Aunins |
Merck |
|
USA |
|
| "Development of adenovirus-vectored HIV-1 Vaccine Candidates" |
| T6.3: Manon Cox |
Protein Sciences Corporation |
Meriden |
USA |
| A recombinant hemagglutinin protein vaccine for influenza produced in insect cells |
| T6.4: Matt Coffey |
Oncolytics Biotech Inc. |
|
Calgary |
Canada |
| Large Scale Production Process for the Oncolytic Agent REOLYSIN® Human Reovirus |
| T6.5: Johannes Gach |
|
|
|
|
| Anti-idiotypic antibody 3H6. A novel promising vaccine against HIV-1? |