PROGRAMME
| Time | Monday, July 31 | Tuesday, August 1 | Wednesday, August 2 | Thursday, August 3 | Friday, August 4 |
| Fundamentals | Supporting technologies | Biopharmaceuticals | Vaccines | Other biologicals and regulatory aspects | |
| 9:30-10:40 | Biologics and animal cell culture: basic aspects Leda Castilho, UFRJ, Brazil |
Bioreactors and operation modes Marc Aucoin, Univ. of Waterloo, Canada |
Biopharmaceuticals: from r-insulin to monoclonal antibodies to ATMP's Manuel Carrondo, IBET, Portugal |
Basic principles of immunology and vaccination Herbert Guedes, UFRJ, Brazil |
Exosome-based biotherapeutics Konstantin Konstantinov, Codiak, USA |
| 10:40-11:50 | Development of recombinant cell lines I: constructs, vectors, gene transfer and clone selection Andrea Maranhão, UnB, Brazil |
Cell separation devices for perfusion processes Ricardo Medronho, UFRJ, Brazil |
Development of processes for manufacturing of therapeutic proteins Leda Castilho, UFRJ, Brazil |
High-throughput analysis of antibody VH/VL pairs to accelerate mAb discovery and vaccine design Brandon DeKosky, Univ. of Kansas (KU), USA |
Gene therapy Rafael Linden, UFRJ, Brazil |
| 11:50-12:10 | Break | Break | Break | Break | Break |
| 12:10-13:20 | Development of recombinant cell lines II: cell stability, gene amplification, targeted integration Hansjörg Hauser, HZI, Germany |
Purification of biopharmaceutical products Rimenys Carvalho, UFRJ, Brazil |
Integrated continuous biomanufacturing Konstantin Konstantinov, Codiak, USA |
Viral vaccine production in animal cell cultures Yvonne Genzel, Max-Planck Institute, Germany |
Applications of stem cells: from drug screening to cell therapies Stevens Rehen, UFRJ, Brazil |
| 13:20-14:30 | Lunch | Lunch and option for 5-min ride-MagLev levitation train | Surprise and Lunch | Lunch and visit to UFRJ Technological Park | Lunch and visit to UFRJ Technological Park |
| 14:30-15:40 | Cell metabolism and cell culture media Francesc Godia, UAB, Spain |
Biochemical and physico-chemical characterization of biologicals Guillermina Forno, UNL, Argentina |
Non-clinical assessments of Immunogenicity Zuben Sauna, FDA, USA |
Recombinant vaccines and virus-like particles Francesc Godia, UAB, Spain |
International regulations for biologicals: an overview Ricardo Castro, UNAM, Mexico |
| 15:40-16:50 | Post-translational modifications Guillermina Forno, UNL, Argentina |
Formulation and stability of biopharmaceutical products Mark Smales, Uiniv. of Kent, United Kingdom |
The biosimilar panorama in 2017 Ernesto Chico, CIM, Cuba |
Anti-viral vaccines from A (AIDS) to Z (Zika): entering a new era of vaccinology Barney Graham, NIH, USA |
Non-clinical and clinical development of biologicals Adriane Oliveira , ANVISA, Brazil |
| 17:00-19:00 | Case study sessions (see below) |
Case study sessions (see below) | Case study sessions . (see below) | Case study sessions (see below) | -- |
| from 19:30 | -- | -- | -- | Dinner at Churrascaria Carretão Lido" (see below) | -- |
CASE STUDY SESSIONS :
From Monday to Thursday , from 17h to 19h, several case study sessions will take place in parallel, allowing participants to choose among the several topics offered each day. Case study sessions will promote a greater interaction among participants by dividing them into small groups to discuss and propose solutions to case studies and technical problems proposed by the speakers.
Monday, July 31
Mon1: Instability of CHO cells: friends and foes, Hansjörg Hauser, Helmholtz Institute, Germany
Mon2 : Generation of stable cell clones using high speed cell sorting, Mariela Bollati, Pasteur Institute of Montevideo, Uruguay
Mon3: EPO case study: development of a biosimilar of Amgen's Epogen, Peter Kalinka, Bionovis, Brazil
Mon4: Rapid mycoplasma testing: key points to consider for implementation, Raphael Greiner, Roche Diagnostics, Germany
Mon5: Monitoring and identifying critical HCPs, Mark Smales, University of Kent, United Kingdom
Mon6: Next-generation sequencing of phage display libraries for antibody discovery, Andrea Maranhão, University of Brasília, Brazil
Tuesday, August 01
Tue1: Monitoring cell respiration rate, Aldo Tonso, University of São Paulo (USP), Brazil
Tue2: Mild hypothermia applied to cell cultures, Claudia Altamirano, Pontifical University of Valparaíso, Chile
Tue3: Modelling of animal cell processes, Elisabeth Augusto, Federal University of São Paulo (UNIFESP), Brazil
Tue4: Connect upstream: QbD enabling upstream platform, Javier Lobo, Sartorius, Spain
Tue5: Flow cytometry to study or characterize cell growth, metabolism, productivity and death, Mariela Bollati, Pasteur Institute of Montevideo, Uruguay
Tue6: Biosimilars: reduced clinical programs, extrapolation of indication, interchangeability and substitution, Laura Castanheira, Prati-Donaduzzi, Brazil
Wednesday, August 02
Wed1: Process economics for mAb production, Alex Xenopoulos, Merck MilliporeSigma, USA
Wed2: Elements of QbD applied to industrial animal cell culture for recombinant proteins production, Alvio Figueredo-Cardero, Biomanguinhos/FIOCRUZ, Brazil
Wed3: Integration of continuous upstream and downstream operations in MAb production, Andreas Castan, GE Healthcare, Sweden
Wed4: Facing media and process related performance variation in mammalian cell culture: Insight and case studies, Christoph Heinrich, Xell AG, Germany
Wed5: Cadence™ Acoustic Separator: Bench Scale, Scale Up, Perfusion, Juliana Groba, Pall Corporation, Brazil
Wed6: Regulatory approach for monoclonal antibodies with clinical indication for autoimmune diseases and oncology: quality issues related to comparability exercise, reduced clinical programs, extrapolation of indications and considerations related to substitution, Laura Castanheira, Prati-Donaduzzi, Brazil
Thursday, August 03
Thu1: Regulatory perspectives on control strategies in the manufacturing of biotechnology products, Richard Ledwidge, Food and Drug Administration (FDA), USA
Thu2: How to deal with antigen-antibody measurement, Roxane Piazza, Butantan Institute, Brazil
Thu3: Deciding on cultivation vessel & process strategy for cell culture-based viral vaccine production, Yvonne Genzel, Max Planck Institute, Germany
Thu4: Infliximab Production Development Partnership (PDP) involving Biomanguinhos, Janssen and Bionovis, Alexander S. Neves, Biomanguinhos/Fiocruz, Brazil
Thu5: Impact of a paradigm change in the production of biopharmaceuticals, João Trasmontano, Biolotus Biotech, Brazil
Thu6: Exploring the known and the unknown side by side - Mass spectrometry in the analysis of metabolomics and in the determination of extractables and leachables, Gabriel Duarte, Thermofisher, Brazil
Social programme - dinner with Brazilian live music at "Churrascaria Carretão Lido" on Thursday, August 3:
On Thursday (August 3) there will be a dinner at "Churrascaria Carretão Lido" (Rua Ronald de Carvalho, 55 - Copacabana - in the 3rd floor of the restaurant). We will head directly from the event to the restaurant, arriving there around 19:45h.
We will have the great musician Artur Elyachar playing nice Brazilian songs for us! We bet many of you will end up dancing great Brazilian hits, as in past editions of the event!
Our speakers are our guests, and for participants and accompanying persons the costs will be the special rate of BRL 65 for the "rodizio churrasco" plus drinks plus 10% service fee, on an individual basis, to be paid at the exit of the restaurant.
We ask the participants willilng to take part of the dinner to sign a list until Wednesday at the event registration desk, so that we can know if we will have more than 60 people, which entitles us to have a whole floor of the restaurant just for us. Signing the list helps us planning and is important for us!
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