Bioprocess and Analytical Method Development - Online Academy
The biotech industry is growing at an exponential rate. Therapies such as monoclonal & polyclonal antibodies, recombinant DNA proteins and viral gene therapies provide exciting opportunities, but also unique challenges in their development and manufacture.
Over 4 weeks and 7 modules, this course offers an accessible look at process and analytical method development for such products. Beginning with the fundamentals of bioprocessing analysis and characterisation, learners will progress through the production process from upstream to harvesting and purification to downstream and formulation. Other aspects such as use of analytical methods, viral safety and regulatory considerations will also be explored.
Suitability - Who should attend?
This course is designed for all professionals directly or indirectly involved with bioprocessing facilities such as:
- Regulatory professionals
Outcome / Qualification etc.
- Learn to define key terms within biopharmaceutical manufacturing
- Consider the use of analytical methods for process monitoring
- Find out how to analyse and characterize biopharmaceuticals and explore technologies such as cloning and cell banking
- Determine what is needed to establish viral safety and maintain compliance with quality and regulatory requirements for bioprocessing
- Develop your understanding of upstream and downstream processing, and formulation
Training Course Content
- Module 1: Introduction
- Module 2: Main steps of the production process: Part 1 - Cell constructs & upstream processing
- Module 3: Main steps of the production process: Part 2 - Product harvesting, purification and formulation
- Module 4: Further investigating upstream, downstream and formulation
- Module 5: Process and analytical method development activities
- Module 6: Viral safety aspects
- Module 7: Main quality & regulatory requirements
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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