Meeting Challenging Market Demands: Can Traditional Column Chromatography Be Eliminated?
Sponsored by: Sartorius Stedim Biotech
- Rapid Cycling Chromatography
Date: 3 December
Time: 3PM London/10AM New York
Intensified mAb Capture with Rapid Cycling Chromatography
Two of the key challenges for the biopharmaceutical industry are pressure to reduce costs and uncertainties of drug production, especially in view of the strong competition in the market. To meet these drivers, the industry is looking for ways to cut costs in both the development of new biologics and bulk manufacture. In addition, the facilities must be flexible and able to handle multiple products. Finally, time to clinic and time to market needs to be shortened to ensure market leadership.
Process intensification is one possibility to meet these goals. In the past, the focus of process intensification was mainly on the upstream side, which pushed the bottlenecks into the downstream area. An important step in DSP is mAb capture. Here the mAb is very specifically captured by a protein A ligand, resulting in >95% of purity. For several decades the default technology has been the use of packed bed column chromatography and diffusion-limited affinity resins. This is a significant pain point in the downstream process, as the flow rate limitations and subsequent underutilization of these resins present considerable investments and process risks for drug manufacturers.
Rapid Cycling Chromatography (RCC) is one way to overcome the limitations of processes based on protein A resins. The development of new chromatographic materials in disposable ready-to-use devices were needed to meet the requirements of RCC, and chromatographic skids had to be adapted to maximize efficiency. The result is a large productivity increase from the mAb capture step and enhanced process flexibility. CoGs are reduced by full utilization of available ligand lifetime, and the one-batch-one-membrane approach significantly reduces key process risks of bioburden and carry-over.
In this exciting webinar, we will present how Sartorius addresses the needs for downstream process intensification with a newly developed Protein A membrane and an optimized RCC skid.
Please register now to reserve your spot and we look forward to welcoming you to our presentation.
Product Manager Chromatography Systems
Xindao Mao joined Sartorius in December 2019 as Product Manager for Chromatography Systems. Before joining Sartorius, he worked as a Corporate Product Manager at the IKA-Werke. In this position, he managed the global business of several product groups in laboratory and analysis technology and successfully led the global launch of several key products. He holds a master's degree in process engineering from RWTH University Aachen, Germany.
Dr. Ricarda Busse,
Product Manager Membrane Chromatography
Dr. Ricarda Busse joined Sartorius Stedim Biotech in February 2018 as Product Manager Membrane Chromatography. She has 6+ years of experience in the biotechnology and bioprocessing industry. Prior to joining Sartorius, she worked as Product and Marketing Manager for affinity chromatography solutions used for recombinant proteins.
She holds a Ph.D. in biology/biochemistry from the Georg-August University of Goettingen. During her time as a doctoral candidate at the Max Planck Institute for Biophysical Chemistry, Goettingen, she worked on upstream and downstream process optimization of recombinant proteins from bacterial, mammalian and insect cell cultures. She also holds an MBA from the European Fernhochschule Hamburg in General Management, where she specialized in digital and international marketing.
Key Learning Objectives
- Learn more about key challenges in mAb capture
- Find out about different approaches to downstream process intensification
- Understand how optimization of a chromatography skid and the development of a new membrane enables Rapid Cycling Chromatography
- Learn more about reducing process risks with Rapid Cycling Chromatography
- Process Development Scientists
- Process Development Managers
- Process Engineers
- Engineering Directors