Rapid Cycling Chromatography drives intensified mAb capture
Sponsored by: Sartorius Stedim Biotech
Date: 2 October
Time: 3PM London/10AM New York
Optimized process performance and productivity with a newly developed protein A membrane
As the biopharmaceutical industry continues to grow and offers new therapies, it also needs to address the following four important pillars: reducing cost, high flexibility, speed to market and increased quality/process robustness. Intensified/connected bio-manufacturing is a hot topic in our industry as it addresses these pain-points by increasing productivity, efficiency, lowering footprint and being cost-effective.
Intensification of the mAb capture step can be achieved by Rapid Cycling Chromatography (RCC). Implementing RCC requires the tuned interaction of a purpose-designed membrane, suitable devices and a supporting skid technology: We developed a new â€œconvecdiffâ€ base membrane that delivers high mass transfer and high permeability, thus resolving the limitations of diffusional and purely convective materials for RCC. To ensure suitability for bioprocessing, providing adequate bed height in a scalable and proven device portfolio is a must. An optimized skid needs to deal with the challenges of running many cycles in a short time - fast flow rates, rapid buffer changes, and handling and analysis of data.
Highly flexible processes using Rapid Cycling Chromatography for mAb capture are enabled by cycle times of 5 to 8 minutes and residence times of seconds. Our prototype membrane exhibits excellent alkaline stability, allowing use of 1 M NaOH for effective bioburden and process risk control. The membrane can be used for more than 100 cycles per batch at low pressure drops, has low fouling propensity, and delivers state-of-the-art performance in terms of contaminant removal and recovery.
Through full lifetime utilization within low batch number processes (e.g. for trial material) and via miniaturization of full-scale manufacturing processes, this new â€œconvecdiffâ€ membrane offers new possibilities for production of clinical and commercial drug substance.
Please register to reserve your spot for this exciting webinar and we look forward to welcoming you to our presentation.
Product Manager Membrane Chromatography
Dr. Ricarda Busse joined Sartorius Stedim Biotech in February 2018 as a Product Manager for Membrane Chromatography. She started her career in 2014 in the biotechnology industry and specialized in affinity chromatography for protein production and bioprocessing.
She has a doctoral degree in biology/biochemistry from the Max Planck Institute of Biophysical Chemistry and holds an MBA from the European Fernhochschule Hamburg.
Global Technology Consultant| Intensified and Continuous BioManufacturing
Ganesh Kumar has over six years of experience in the bio-pharmaceutical industry both as an end-user and as a solution provider. He holds a Master’s degree in Chemical and Bioprocess Engineering from Hamburg University of Technology (TU Hamburg), Germany.
He started off his career in 2013 as a DSP Process Development Engineer within the Manufacturing Sciences and Technology (MSAT) group at Lonza, Singapore.
Ganesh joined Sartorius in 2016 as a Process Engineer | Consultant within the Integrated Solutions team based in Guxhagen, Germany. In this role, he managed as well as executed several single-use | stainless steel DSP projects and was one of the key contributors in shaping the P4SÂ® conceptual design platform that enables customers to choose a process centric approach towards SU facility design.
Since April 2019, Ganesh holds a position as a Global DSP Tech Consultant in the area of Intensified and Continuous Biomanufacturing within Sartorius.
Key Learning Objectives
- New â€œconvecdiffâ€ base membrane allows intensified mAb capture employing Rapid Cycling Chromatography (RCC)
- It takes 3 to RCC: â€œconvecdiffâ€ membrane, scalable device portfolio, optimized skid
- Short cycle time, caustic stability, low pressure drops and low fouling propensity of the membrane ensures optimal process performance
- Lifetime utilization and process miniaturization facilitate cost effective production of clinical and commercial drug substance
- Process Development Scientists
- Process Development Managers
- Process Engineers
- Engineering Directors