None

TARGET AUDIENCE: Individuals from academia and industry, that are involved in product and process development, regulatory, quality assurance and manufacturing of biopharmaceuticals. Attendees from regulatory agencies may also benefit depending on their areas of interest and level of experience.

The agenda discussed includes:
Tasks, Screening, Data to Information Handling, Modelling and Control
Upstream Processing, Down Stream Processing
Process Development, Process Characterization, Technology Transfer

Screening methods

• General differences of shaken and stirred bioreactors
• Designing suitable screening protocols in shaken bioreactors; scale-up to lab-scale stirred tank bioreactors
• Introduction to on-line measuring techniques on secondary screening level; generating big data sets; replacing in part lab scale stirred tank bioreactors for process development by highly parallelized shaken bioreactor systems
• Fed-batch operation of shaken bioreactors

Information generation

• Handling Big Data Sets: data quality, data consistency, data reduction
• automated extraction of information from historical/large data sets and generation of hypotheses
• Integrating dynamic process conditions for quicker and more knowledge

USP Development

• Converting information in scalable mechanistic knowledge using a physiological approach
• Physiological control strategies
   

Modelling & Control

• Models for bioprocesses: unstructured, structured, metabolic
• Model building tools
• Model-based estimation
• Advanced control concepts

DSP Development

• Process Characterization and Continued Process Verification
• Root Cause Analysis of Fail Batches using Historical Data analysis
• Identification of interaction effects between unit operations

QbD and PAT

• Define CQAs, explain the link between CQAs and Design Space, the role of Risk Assessment and finding the appropriate tool
• The role of PAT in QbD paradigm
• Overcoming challenges of implementing QbD
• QbD implementation for commercialization of biotech products