Provide an introduction to industry 4.0 and how the principles of industry 4.0 have been applied to the (bio)pharmaceutical industry and specifically process control.Provide an introduction to novel and advanced medicinal products such as combination products and their manufacture.

 

Module Content 

• Process Control in biopharma manufacturing via automation
• Data management systems in biopharma
• Industry 4.0 and its application biopharma manufacturing i.e., Pharma 4.0
• Digitisation and digitalisation of processes within the biopharma manufacturing environment
• Rapid Micro Methods and digital advances in QC analysis
• Achieving Real time release
• Computational Fluid Dynamics and Modelling in biopharma
• Role of machine learning, artificial intelligence, in the future of biopharma
• Introduction to marketed biopharmaceutical combination devices such as pre-filled syringes, auto-injectors, inhalers and antibody-drug conjugates
• Material and physical science of primary and secondary packaging of biopharmaceuticals
• Manufacturing considerations for combination products
• Device design and verification including human factor studies
• Design History File
• Regulatory requirements around combination devices (EU MDR, 21CFR820 etc.)
• Next generation digital Combination devices
• Cell and Gene Therapies