Continuous Biomanufacturing of mAbs
Sponsored by: Sartorius Stedim Biotech
- Biosolve Cost Modeling Tool
Date: 14 November
Time: 3PM London/10AM New York
Challenges, Future Trends and the Significance of Cost Modelling
Managing the cost of highly expensive Biopharmaceutical products is critical for improving their access to patients. This is especially true for Biosimilars which must address the affordability of life saving treatments. Continuous and intensified processes have a potential to disrupt the high manufacturing costs of Biopharmaceuticals, such as monoclonal Antibodies (mAbs), and are the next step in the evolution of biopharmaceutical manufacturing facilities. The manufacture of Biopharmaceuticals using fully continuous processes is attracting great interest within the industry. Enzene is one of the first companies to develop a fully integrated continuous GMP manufacturing facility. Continuous manufacturing can significantly increase the volumetric productivity and at the same time lower Cost of Goods (CoGs).
In this talk, we will discuss the challenges associated with developing a continuous manufacturing process and facility. Additionally, we will present the capacity modeling and CoGs analysis of Enzene’s continuous manufacturing process by using the Biosolve Cost Modeling Tool.
In summary, continuous processing allows building of low investment, high productivity facilities, thus reducing the overall cost/gram of the product. By having a total single-use, continuous suite, the overall footprint of the manufacturing site was significantly reduced, thus resulting in a very attractive proposition for the development of an overall continuous process for mAbs.
Whole-Time Director and CSO, Enzene Biosciences
• Himanshu is a passionate leader and innovator who believes that critical healthcare should be accessible to everyone who needs it.
• He holds a PhD in Biochemistry from the University of Tennessee and has previously held various leadership roles at Waters Corporation, Amgen, Intas Biopharmaceuticals Ltd.
• Himanshu has participated in the launch of multiple Blockbuster products and has championed launch of a Biosimilar product in EU and 6 Biosimilar products in India.
• He has over 50 publics/patents in the field of Biological drug development.
Process Modeling Manager, Sartorius Stedim Biotech
Priyanka Gupta is the Bioprocess Modeling Manager for Sartorius Stedim Biotech based out of San Francisco, USA. In this current role she leads a team of professionals who establish business modes by analyzing Cost of Goods of any given manufacturing process using the cost modeling tool called Biosolve. Using this tool one can evaluate and incorporate the most cost efficient production processes for any given modality like mAbs, Vaccines, Gene Therapy and ADCs.
Priyanka has worked for Sartorius for 12+ years. Before the present position she was based in Seattle, USA as the Purification Process Scientist for Sartorius where she interacted with mAb, Vaccine, Recombinant Protein etc. downstream Scientists to establish and optimize their process. Before joining Sartorius she was part of the Process Development Group at Amgen for 4+ years. She has a Masters in Chemical Engg. from Florida State University, USA and a Bachelors and Masters Degree in Biomedical Engg. and Biotechnology from IIT Delhi.
Key Learning Objectives
- Continuous processes for mAbs and its advantages
- How Cost of Goods analysis can really shed light on manufacturing cost
- Lower footprint of single-use manufacturing facilities
- Head of Manufacturing
- Head of Research and Process Development
- Project Managers
- Process Development Scientists
- Manufacturing Engineers