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 been 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 good sales. Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite, some challenges still exist in applying continuous manufacturing processing for biologics, that approach could address some of the current limitations of large-scale fed-batch processes.

Why should you attend?

• Understanding the continuous manufacturing alignment with data integrity and digital transformation to increasing manufacturing and operational productivity, excellence and product qualit
• Learn how to navigating and overcome key process challenges for successful implementation of continuous manufacturing:

• • • • • Develop control algorithms
        • Implement PAT technology
        • Design continuous equipment for all unit operations
        • Develop a strategy for bioburden control
        • Overcome lack of operational experience

Objectives

• Setting-up the context of the bioindustry leading to develop and implement 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 up a continuous proces
• Learn how to implement process analytical technologies (PAT) to providesoperators 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, media and small size 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

Speaker

Kossi Molley, Chemist; LSSBB; PMP