IBC Life Sciences and the Scientific Advisory Committees are currently accepting speaker proposals for Process2Product. If you are working in any of the following scientific/business topic areas, you are invited to submit a proposal for a podium presentation Friday, April 13, 2012.

Please consider submitting an abstract using the form below in one of the following topic areas:

Phase-Specific Approaches for Process and Product Monitoring in Unit Operations

• Case studies and examples in unit operations
• Phase 1 and Phase 2 Clinical Manufacturing
• Phase 3 Clinical Manufacturing
• Post-Phase 3 Commercial Manufacturing

Raw Material Variability and Control Strategies

• MVDA approaches
• PAT applications for raw material process control
• Correlating raw materials to cell cultures
• Raw material variability and global supply chain management for monitoring
• Control and monitoring of raw materials and the challenges they represent for process control 2
• RAMAN screening approaches
• Analytical methods for hydrolysates

Novel Process Analytical Technologies (PAT) and QbD Applications

• PAT applications for raw material control process development
• Cell-level PAT approaches
• Integration of PAT elements into process development and process characterization
• Novel PAT technologies
• Use of PAT in continuous (or connected) processing
• QbD in the context of continuous process verification

Multivariate Data Analysis Models for Process Monitoring and Control

• Validating MVDA models
• Strategies for developing models for clinical manufacturing, when there is a lot less data
• Process modeling and troubleshooting in MVDA
• Raw control strategies using MVDA
• Using -Omics techniques with MVDA (proteomics, transcriptomes, metabolomics, etc)
• Case studies of successful BLA's using MVDA
• Monitoring large scale chromatography operations using MVA
• Statistical methods (MVA, SPC, PCA)
• Fully real-time applications on MVDA (MV Monitoring)

Data Integration and Knowledge Management throughout the Product Lifecycle

• How to apply knowledge management tools to incorporate data into your next process design phase or your next molecule?
• Case studies of data Integration and solutions
• Bridging the gap from academia to industry
• Product lifecycle knowledge management
• Novel data management systems
• How to handle the deluge of data?
• Tools and systems to handle information from various sources in various forms

Scale-up/Scale-down Models for Bioprocesses and Process Verification/Process Improvement

• How to develop a scale-down bioreactor model that accurately reflects what is happening in manufacturing?
• How to develop design space using a scale-down model?
• Qualifying scale-down models - for cell culture, purification, formulations and other unit operations in a compressed timeframe
• Ultra-scale down methods and process miniaturization
• Scale-up processes from bench scale to manufacturing scale
• Process biomodels and mathematical models for various process steps
• Scale-up/scale-down models for biopharm manufacturing process

Implementation of Advanced Analytical Measurement Methods for Process Monitoring and Control

• What to measure? How to measure it? How to qualify measurement methods?
• Ensuring accuracy of measurement methods
• Automated sampling and sample analysis from a bioreactor - what is the best approach?
• Real-time process monitoring, control and analysis
• Offline measurement methods
• Process monitoring throughout the product lifecycle
• Approaches to identify CPP's/CQA 's and manage a monitoring program
• Strategies for cell culture processes
• KMOQ (Key Measures of Quality) in Processing
• Spectral and chemometric methods (Raman, NIR, FTIR)

Implementation of Novel Sensors, New Technologies and Automation for Process Improvement

• What is the current state of the art in sensor technologies for continuous process improvement?
• Optical sensors
• Co2 sensors
• How to bring new technologies to bear on GMP
• How to bring automation into the manufacturing plant (i.e. automated cell density measurements)
• Nanotechnologies and Miniaturization for monitoring subvisible particulates

Strategies for Continued Process Verification as part of the Validation Lifecycle