Event sessions
Lectures and posters will be included in 8 principal sessions
1. Cell line development and protein expression systems
Protein engineering for developability enhancement.
Protein expression systems. Transient and stable expression.
Cellular engineering. Glycoengineering.
Multimeric protein production.
Influence of culture conditions on protein production in mammalian cells.
Metabolic biomarkers on clone selection and process optimization.
Chairwoman: MSc. Tammy Boggniano
2. Culture for glycoprotein and antibody production
Cell culture media development for improvement of productivity in the perfusion process (feed-perfusion).
New trends in the Perfusion systems to fermentations of mammalian cells at commercial scale productions (retention devices).
Scale up of perfusion process.
Impact of multivariate analysis on improving the upstream process.
Future impact of technology 4.0 in the development of mammalian cell fermentations for production of recombinant proteins.
Omics in process development of glycoproteins and monoclonal antibodies.
3. Downstream platforms
Continuous downstream applications.
Novel chromatographic resins.
Pressure-Flow experiments, packing, and modeling for scale-up.
Strategies for development and purification of recombinant antibodies and proteins.
New developments in membranes for bioprocessing.
4. Formulation: Protein stability and Aggregation
Stability prediction.
Protein-protein interaction and impact on aggregation.
Novel excipients.
Lyophilization challenges and concentrated proteins formulations.
Complex formulation based in LPS platform.
5. Quality and regulatory trends
New approaches in quality management of COVID-19 vaccines. What can we learn for other new products?
Innovation, Regulations and Sanitary Registration during COVID-19 vaccines development.
cGMP on Multiproduct/Multipurpose management of biomanufacturing facilities.
Risk and control strategy of Mycoplasma in bioprocessing.
Comparability study during process development. Soberana Vaccine Case Study.
ISO 9001-2015 Quality Systems Certification in a Biotech company.
Process Analytical Technologies (PAT) and Data Analytics for the Manufacture of Monoclonal Antibodies (Scott R Rudge).
Correlation study between predictive clinical efficacy bioassay and bioassay for product release. Soberana Vaccine Case Study.
Approach for Supplier Evaluation and Selection in a Pharma company.
6. Modern techniques in biopharmaceutical products characterization
Chemical-physical methods for the characterization of immunotherapeutics products (development, standardization, etc).
Relationship between molecular structure and biological activity in biopharmaceutical products.
The rol of modern mass spectrometry for biosimilar development.
The characterization of the receptor binding domain (RBD) of the SARS-CoV-2 spike protein (S) using modern analytical methods.
Characterization of innovative products (including vaccines against covid19).
Chairwoman: MSc. Judey A. García
7. Challenges in logistics and supply chains in science
The Supply Management of Raw Materials and Materials in the Biotechnology Industry in the Current International Context.
Validation of the Cold Chain for the international transportation of biotechnological products (COVID-19 vaccines as study cases).
Warehouse Management in the Biopharmaceutical Industry. Supply Chain Resilience: Bottlenecks & Core Capacities.
8. Business challenges and process economics
Business challenges and process economics.
Chairman: MSc. Einard Blanco