In-House Training
Continuous biomanufacturing has the potential to improve product quality, reduce costs, and accelerate time to market. However, alongside these advantages, there are challenges that must be addressed when implementing continuous bioprocessing. These challenges include regulatory considerations, adapted technologies, development steps, and validation.
This short live online training course will help you understand the fundamentals of implementing a continuous manufacturing approach for unit operations, whether upstream and/or downstream processing. During the course, you will review the regulatory and quality framework for continuous bioprocessing to ensure compliance. You will also assess the major steps needed to develop a continuous approach and receive practical guidance for monitoring, controlling, and validating continuous bioprocessing.
Understand the essential concepts of continuous bioprocessing and technologies that will help you design and implement continuous manufacturing
Review regulatory and quality aspects (ICHQ13) of continuous biomanufacturing to ensure your continuous process is compliant
Examine key steps to develop a continuous process, including the upstream and downstream technologies available to implement a successful continuous approach
Appreciate the potential positives and negatives of adopting continuous biomanufacturing to your situation
Learn to implement monitoring and control strategies for your continuous bioprocess approach to ensure product quality
Examine continuous process validation to demonstrate consistency and maintain product safety and quality
This course is aimed at professionals working in biopharmaceutical manufacturing. It is suited to those who currently operate a continuous process or are considering a continuous approach.
Bioprocess Scientists
Upstream Professionals
Downstream Professionals
Bioprocess Development Personnel
Bioprocess Engineers
Production Personnel/Technicians
Quality Professionals
Regulatory Affairs Professionals
Introduction
• Introductions and overview of the course and format
Overview of continuous biomanufacturing
• History of continuous manufacturing
• Reviewing and understanding the pro’s and cons of a continuous approach in biotech
• Latest technologies for large-scale production of recombinant proteins
• The necessity for flexible manufacturing processes
• The challenge of managing manufacturing costs
• The implementation of single-use systems
Upstream perfusion technologies
• Principles of various cell culture modes: batch, fed-batch, intensified fed-batch, and perfusion
• Examine cell metabolism in fed-batch vs perfusion
• How to move from batch to perfusion system
• Cell retention technologies
Downstream technologies
• Fundamentals of continuous chromatography
• Available technologies based on chromatography resins
• Continuous buffer feed
• Continuous viral inactivation
Regulatory & quality considerations for continuous biomanufacturing
• Understand the current regulatory landscape
• ICH, EU and US FDA Guidelines
• Review of ICH Q13
• Steady state vs State-of Control
• Understand the diversion points
• Review the limitations for biopharmaceutical processes
• Expectations for Process Analytical Technologies (PAT)
Validation for continuous processes
• General principles of process validation
• Understand the key differences to classical batch processing
• Continuous process performance qualification and batch definition
• Setting-up the control strategy
• Residence time distribution
• Continuous viral clearance
• Continuous filtration
• Bioburden control
The future of continuous processing
• What are the latest purification technologies?
• Review the business case for continuous manufacturing
• Further development of Process Analytical Technologies
• Real-time of drug substance release (RTR)
Please contact us at mylene.talabardon@biotechnologyconsultant.com