Biotechnology Production Operations

What You Will Learn

• 1 Learn the fundamental principles of bioprocess engineering and the stages of biological production.
• 2 Understand upstream processing techniques including cell culture, media preparation, and inoculum development.
• 3 Apply downstream purification methods such as chromatography, filtration, and virus inactivation.
• 4 Analyze bioreactor configurations, control strategies, and scale-up considerations for microbial and mammalian systems.
• 5 Implement quality control systems and regulatory compliance frameworks including cGMP and ICH guidelines.
• 6 Utilize process analytical technology (PAT) and automation tools for real-time monitoring and control.
• 7 Develop sterilization and aseptic processing protocols to maintain product integrity.
• 8 Evaluate facility design principles, HVAC systems, and cleanroom classifications for biotech manufacturing.
• 9 Manage supply chain and logistics challenges specific to cold chain storage and distribution of biologics.
• 10 Explore emerging technologies such as continuous processing, cell and gene therapy manufacturing, and single-use systems.