Event sessions
Lectures and posters will be included in 8 principal sessions
1. Cell line development and protein expression systems
Cell line engineering ensuring stability, quality and developability.
Cell line to produce multi specific antibodies.
Strategies in cell line development to speed-to-clinic.
Cell lines for therapeutic development.
Chairwoman: MSc. Tammy Boggniano
2. Culture for glycoprotein and antibody production
Perfusion mammalian cell culture for recombinant protein manufacturing.
Development technologies for improvement of productivity in the perfusion processes - Scale up of perfusion process.
Impact of multivariate analysis of metabolites on improving the upstream process.
Technology 4.0 use in the mammalian cell fermentation for production of recombinant proteins.
The used of metabolomics tools in the improving the production processes of glycoproteins and monoclonal antibodies.
3. Downstream platforms
Process intensification in downstream processing: continuous processing, single use technologies, novel filtration strategies and novel chromatographic materials.
Unit operations and purification strategies innovations for mAb processing.
Research approaches in downstream processing of pharmaceutically relevant proteins.
Downstream process design for personalized medicine.
Modelling strategies for product and process understanding.
Downstream process development strategies.
4. Formulation: Protein stability and Aggregation
Al/machine learning in the development of therapeutic protein formulation. Excipient screening, formulation design and predicting stability.
Biophysical methods for formulation screening and monitoring stability: Predictive parameters of stability.
Protein Aggregation: controlling aggregation and particle formation.
Sub-micron particle characterization and quantification.
High protein concentration formulations: Reducing viscosity and aggregation.
Improving sryngeability and delivery of high protein concentration formulations.
Vaccines characterization and manufacturing.
Delivery systems of tumoral antigens for therapeutic cancer vaccines.
Novel drug delivery systems: nucleic acid formulation and delivery for gene therapy and vaccines.
Lipid nanoparticles and virus-like particles.
Quality by design of therapeutic protein formulation.
Stress testing and forced degradation studies of therapeutic protein formulations.
Stability and charactertization of therapeutic protein co-formulations.
Novel excipients.
Recent developments in lyiophilization and alternatives drying techniques of therapeutic protein formulations.
Getting ready for the IPO process.
5. Modern techniques in biopharmaceutical products characterization
Chemical physical methods for the characterization of Immunotherapeutic products (development, standardization…)
Relationship between molecular structure and biological activity in biopharmaceutical products.
The rol of modern Mass Spectrometry for Biosimilar Development.
Characterization of innovative products.
6. Quality and regulatory trends
cGMP on Multiproduct/Multipurpose management of biomanufacturing facilities.
Risk management and control strategy of adventitious agents in bioprocessing.
Comparability study during process development. An ISO 9001-2015 Quality Systems.
Certification in a Biotech company.
Process Analytical Technologies (PAT) and Data Analytics for the Manufacture of Monoclonal Antibodies.
Correlation study between predictive clinical efficacy bioassay and bioassay for product release. Case Studies.
Approach for Supplier Evaluation and Selection in a Pharma company.
Chairwoman: PhD. Mercedes Cedeño
7. Improvement of regulatory challenges: logistics and technology vision
The Supply Management of Raw Materials and Materials in the Biotechnology Industry in the Current International Context.
Warehouse Management in the Biopharmaceutical Industry.
Circular Economy and Industry 5.0.
Supply Chain Resilience: Bottlenecks & Core Capacities.
Automatization of critical systems as support of production.
Critical systems as support for production processes.
Risk-based maintenance management to improve the quality and availability of critical equipment and systems in biotech industry.
Energy efficiency and renewable energy sources.
8. Business challenges and process economics
Current trends in biotech products and financing landscape.
Challenges for developing and financing early stage biotech pipelines.
The role of business models in attracting venture capital investment.
Getting ready for the IPO process.
Chairman: MSc. Einard Blanco