Acoustic Wave Separation, An Enabling Technology for Continuous Downstream Processing
Speakers: René Gantier, Ph.D., R&D Director, Pall Life Sciences and Chris Leidel, VP of Operations, FloDesign Sonics
The biopharmaceutical industry has implemented single-use and/or disposable technologies in bioprocesses for the past ten years with clear benefits in terms of reduced product cost of goods, capital expenses and facility footprint while process productivity and flexibility is increased. The same key benefits are also expected from the implementation of continuous bioprocessing. There is an obvious synergy existing between those two approaches for biotech processes. Disposable technologies facilitate process step integration and further reduce process cost when implemented for an extended period of time within a continuous bioprocess.
Pall Life Sciences has a number of cutting edge technologies that facilitate process intensification and continuous processing to support the adoption of continuous downstream processing in biotech applications. These technologies include the BioSMB® multicolumn continuous chromatography platform and the Cadence™ Inline Concentrator.
On June 15, 2015 Pall Corporation announced the signing of an exclusive license for acoustic wave separation (AWS), a disruptive technology from FloDesign Sonics (FDS) for cell culture clarification for both fed-batch and perfusion applications. The AWS technology enables very high-efficiency continuous removal of the cells in a closed system without centrifugation, thereby streamlining a challenging step in the biologics manufacturing process within a small operating footprint. The technology will complement Pall's industry-leading STAX™ depth filtration products to enable continuous clarification of cell culture, enabling integration of the bioreactor with downstream processing.
This webinar will provide a brief overview of continuous processing technologies and will highlight the AWS technology.
Solving the Implementation Challenges of Continuous Feedback Control in Cell Culture Processes
Speaker: Jane Ring, Research Scientist, Integrated Pharm Solutions Applications Development, EMD Millipore Corporation
Traditionally, industrial scale mammalian cell culture processes have been controlled through monitoring of temperature, pH and DO (dissolved oxygen) concentration using a continuous feedback control system developed to maintain these parameters at specific set points. As our understanding of the factors impacting cell culture processes increases, implementation of its principles of Quality by Design into cell culture performance is likewise expanding. Therefore, the need to develop and implement new sensor technologies that enable feedback control based on the measurement of additional parameters such as viable cell density (VCD), dissolved carbon dioxide or glucose concentrations is apparent. As these new sensor technologies are developed, users are challenged with their implementation in the context of fixed bioreactor designs.
Our platform of pilot- and clinical-scale single-use bioreactors addresses this challenge through its Mobius® SensorReady technology, an external circulation loop that is connected to the bioreactors via sterile connectors. This webinar will demonstrate the flexibility and effectiveness of bulk process measurements, and applicability of this sensor technology to both suspension and adherent cell culture processes.
Engineering and Cell Culture Performance of a New Large-Scale Single-Use Bioreactor Design
Speaker: Bojan Isailovic, Principal R&D Engineer, Pall Life Sciences
Panelists: Michael Kradolfer, Global Product Manager, Pall Life Sciences and Byron J Rees, R & D Applications Manager, Pall Life Sciences
Pall Life Sciences invites you to learn the latest details of a new range of large scale single-use bioreactor systems specifically designed to address the needs of commercial scale biotechnology production operations. Hear directly from members of the team that developed the Allegro™ STR range of single-use systems as they discuss in detail their approach to incorporating a large format, bottom mounted impeller into single-use bioreactor. A comparison of Computational Fluid Dynamics predictions to the actual observed mixing, mass transfer, and temperature stability characteristics at the 200 liter scale will be presented with CFD projections for the soon to be introduced 1000 liter and 2000 liter scale devices. The team will also address robustness and operational simplicity enhancements that make the Allegro STR family ideally suited to industrial scale operations. Finally, the panel will present cell culture performance data from an industrial CHO cell line demonstrating the utility of the Allegro STR systems in achieving the benefits of single use technology with far reduced risks and with minimal operational complexity.
Demonstration of Crimp Cleanliness and Microbial Integrity During Sterile Sampling of Bioprocess Products
Speaker: Corinne Miller, R&D Manager, Virology & Microbiological Sciences
When it comes to biopharmaceuticals, a critical step in any sampling is disconnection of the sampling container from the process container. Separation and isolation of compartments, including vessels, containers, or single-use assemblies, can be a cause of contamination.
During this webinar, we will present results of a NovaSeal™ crimping tool study where the cleanliness and integrity of the tubing crimp to both bacterial and viral passage have been evaluated. Crimp cleanliness and integrity to virus outgress has been demonstrated for both silicone and thermoplastic elastomer (TPE) tubing.
When CIP Spray Systems are not Recommended or Unavailable: Then What? A Scientific Perspective
Speaker: Jeff Phillips, Director, Science and Marketing, Alconox, Inc.
This webinar will cover general chemistry of aqueous cleaning with a focus on the use of high foaming detergents or non-spray ball CIP cleaning. Also covered will be the 9 variables in effective cleaning. This will cover things such as how a surface is treated before it’s cleaned through how these surfaces are stored when cleaning has been completed and everything in between. A focus will be paid on the often forgotten examples when more powerful emulsifying detergent use may be necessary or preferable compared to those detergents with little or no emulsifying capability. By attending this webinar you will understand the chemistry of aqueous cleaning, understand the variables and how to utilize them to achieve optimal cleaning, and when to use manual and/or high foaming detergents for cleaning pharmaceutical manufacturing equipment.
Performance and Fluid Contact Extractables Evaluation of Polyethylene Films
Speaker: Karen Green, Senior Product Manager, Mobius® Single-use Assemblies
Biopharmaceutical companies are using single-use containers and assemblies for upstream and downstream processes at an ever increasing rate. Since process fluids come in contact with the inner film layer of these single-use containers, there is a need to understand the extractables profile at room and elevated temperatures and over prolonged time of exposure. This webinar will outline the study that determined the extractables profile of our new PureFlex™ Plus film and original PureFlex™ film. By attending this event, you will learn about the model stream approach used in the study and why we chose this approach instead of conducting actual formulations. We will present out the results of the extractables profile for the new PureFlex™ Plus film and answer any questions you may have about extractables and leachables as they relate to single-use technologies.