The role of analytical characterization is ever-evolving with the advent of new modalities and as new product formats move into the regulatory process. There is a near-constant cycle of adaptation and innovation, which is fuelled by the need to provide ever more complex data across a wide range of analytical methods. Unique product features, software, and feature combinations are explored consistently and further feed into the progression of the analytical development field.
The need to ensure quality is designed and built into the product, to set in place appropriate and documented processes and procedures, to validate designs and processes, to create and maintain a feedback loop for corrective and preventive actions are among the many responsibilities and requirements of every biopharmaceutical company. As Good Manufacturing Practice (GMP) regulations evolve, quality concepts are changing as well. Today, biologic manufacturers are faced with new quality systems, invoking a huge paradigm shift.
BioAnalytics as part of Biologics Manufacturing Asia is bringing together key stakeholders in Analytical Method Development, Product and Process Characterization, Validation, Quality Assurance and Quality Control amongst others to convene at the largest bioprocess business and technology convention in Asia Pacific! In 2020, 500+ biomanufacturing stakeholders from BIG Pharma, Biopharma, Contract Manufacturing Organisations, Academic & Research Institutes, Regulatory Authorities across Singapore, South Korea, Taiwan, Japan, Australia, India, Indonesia, Malaysia, and China will congregate to discover, discuss and debate on the best practices in analytics and quality to make better biologic drugs cheaper and faster!
MULTI-ATTRIBUTE METHODS AND PROCESS CHARACTERISATION
- Integrative multi-omics data and model-driven approaches for enhanced bioprocessing
- Multivariate Tools for Design, Data Acquisition and Analysis
- Implementing High Throughput Process Development (HTPD) Approach into mAb Downstream Process Characterization
- Case Study: Automated Functionally Closed Platform
REAL-TIME CONTINUOUS MONITORING & RELEASE
- Changes in Requirements to Data Management and Bioprocess Data Analytics when Establishing Data Integrity
- Tools for Real Time Monitoring and High Throughput Analytics
- Residence time modelling of continuous integration biomanfacturing processes
ASSAY AND PRODUCT CHARACTERISATION OF CELL THERAPY PRODUCTS
- Identifying Critical Quality Attributes (CQAs) and Development of New Technologies for In-Line, Rapid Quality Measurements
- ‘Combinatorial testing of serial process parameters for optimal cell and gene therapy manufacturing’
- Mass Spectrometry for Higher Order Structure
- Flow Cytometry Assay Validation
FLEXIBLE MULTI-PRODUCT FACILITY DESIGN & ENGINEERING
- Facility Layout Planning with SHELL and Fuzzy AHP Method Based on Human Reliability for Operating Theatre
- Challenges and Key Technologies in Robotic Cell Layout Design and Optimization
- 100% SUT based Facility and Operations
- Design and Qualification of Aseptic Manufacturing Facilities for Cell and Gene Therapy