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.
• Understand the terminology of biopharmaceutical manufacturing
• Investigate analysis and characterisation of biopharmaceuticals
• Explore key technologies used for cloning, cell banking and characterisation
• Comprehend harvesting technologies and purification steps
• Develop your understanding of upsteaming, downstreaming and formulation
• Consider the use of analytical methods for process monitoring
• Determine what is needed to establish viral safety
• Ascertain quality and regulatory requirements for bioprocessing
Margit is a specialist in process, product and analytical methods development for preclinical and clinical production phases as well as for commercial supply. After completing her doctorate in Vienna, Margit began working at Boehringer Ingelheim, eventually establishing and becoming the head of the new division of manufacturing sciences.
She moved on to become the Quality Director and later on the Technology, R&D and Innovation Director for NOVASEP in France, before setting her own consultancy. She now assists clients in the evaluation, optimization and development of processes, analytics and technologies including innovative ones for Up & Downstream processing and Formulation. She has 25 years of experience in the industry and worked on more than 50 different products.
This course is designed for all professionals directly or indirectly involved with bioprocessing facilities such as:
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
Once you have registered you will be given login details to access the course