Continuous Manufacturing Processes for Biopharmaceutical Products
Continuous Manufacturing Processes for Biopharmaceutical Products
Description
The biopharmaceutical industry is driven by the need to increase production and reduce costs while maintaining product quality and has increasingly focused on intensification of processes to accomplish this goal. The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of goods sold. Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite some challenges that still exist in applying continuous manufacturing processing for biologics, this approach could address some of the current limitations of large-scale fed-batch processes.
Why should you attend?
- Understand how continuous manufacturing aligns with data integrity and digital transformation to increase manufacturing and operational productivity, excellence, and product quality
- Learn how to navigate and overcome key process challenges for the successful implementation of continuous manufacturing:
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- – Develop control algorithms
- – Implement PAT technology
- – Design continuous equipment for all unit operations
- – Develop a strategy for bioburden control
- – Overcome a lack of operational experience
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Objectives
- Setting up the context of the bioindustry, leading to the development and implementation of new manufacturing technologies for recombinant proteins
- Understand the upstream and downstream manufacturing technologies, past, present, and future, their respective benefits and drawbacks
- Propose methods to build a continuous process
- Learn how to implement process analytical technologies (PAT) to provide operators with greater control of the cellular environment and metabolism
- Understand the benefits of applying continuous manufacturing (regulatory flexibility, manufacturing flexibility, productivity, and economics)
- Understand the regulatory expectations on continuous manufacturing (ICH Q13)
- What are the challenges?
- Learn the specificities of continuous manufacturing when considering its validation
- Understand how to set up a control strategy for continuous processes
Who should attend
- Big, medium, and small-sized pharma companies, medical device companies, biopharma companies
- Process development
- CMC development program
- Manufacturing Science and Technology
- Manufacturing and Operation
- QC and stability control
- Quality Assurance & Validation
- Drug Regulatory Affairs
Education approach
- Lecture sessions are illustrated with practical questions and examples
- Practical exercises include examples and discussions
