Solving the Implementation Challenges of Continuous Feedback Control in Cell Culture Processes
Webinar Date: October 6, 2015, 11:00 am EST
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.
Listen to recordings of past webinars from INTERPHEX' Spring Webinar Series. The Webinar Series aims to support our robust conference program and dedication to providing cutting-edge Innovation, Technologies and Knowledge.
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.
Taking Life Sciences to the Cloud
Speakers: John Niziolek, Practice Leader, Compliance, Cornerstone OnDemand and Aaron Weinstein, Senior Director - Validation Services, IPS - Integrated Project Services
Life science organizations face unprecedented compliance and transparency expectations today. In order to meet requirements, focusing on the development of your people has to be just as important as your improving upon your product. But is there a way to continually develop your staff to meet new requirements without it interfering with your core business?
Performance and Economics Analysis of Fully Automated Single-use Tangential Flow Filtration Process
Speaker: Engin Ayturk, Ph.D., BioPharm Applications R&D, PALL Corporation
Fully automated design approach to single-use tangential flow filtration (SUTFF) brings real-time process control, monitoring, flexibility and reliability in manufacture. Gamma irradiated Cadence™ Single-use TFF modules are scalable and easy to use, and form part of the fully automated UF/DF solution from Pall Life Sciences. This approach is well suited for R&D, clinical manufacturing or commercial production up to several hundreds of liters. The system can be implemented in multi-purpose or multi-product facilities, or CMOs (flexible facilities), for applications with containment or safety issues and processes targeting increased productivity. In addition to the application data showcasing SUTFF module performance, a detailed process economics modeling analysis will compare single-use versus conventional stainless steel TFF technologies and quantify the impact of key process parameters. In this context, the modeling strategy and the key points of SUTFF process economics will be presented via sensitivity and benchmark analyses under the main cost of goods categories of capital, materials, consumables, labor and facility operating costs.
Single Pass Tangential Flow Filtration for Bioprocessing
Speaker: Joseph Parrella, Biomanufacturing Engineer, Biomanufacturing Sciences Network, EMD Millipore
Downstream purification processes for biopharmaceutical products are being challenged by increasing bioreactor titers as well as demand for higher concentration final formulations. In some cases, these challenges may result in a reduction in facility run rate or process yield. Single pass tangential flow filtration (SPTFF) provides a simple and effective solution to overcome these challenges without requiring major changes to facilities or purification processes. This webinar reviews the advantages of SPTFF, discusses applications where SPTFF adds value, provides recommendations for process development, and presents guidance for scale up and implementation.
Going Beyond The Batch: Benefitting From Continuous Thermal Viral Inactivation & Sterilization
When used for viral inactivation, sterilization, or pasteurization of liquid biologicals such as media, pharmaceuticals, and nutraceuticals, Continuous Flow Thermal (CFT) Processing offers many crucial advantages over traditional processing.
Optimizing a Continuous Wet Granulation Process by Understanding Granule Properties
In developing a continuous wet granulation process, it is easy to produce a large number of samples by varying both the formulation as well as the process parameters. Commonly used granule measurements include loss-on drying of residual moisture content, and particle size measurements from which correlations including the Carr Index and Hausner ration may be calculated. However, it is seen that these measurements are not sufficient to differentiate between a large number of samples produced at conditions which are not drastically different. Using a powder rheometer, we have been able to repeatably measure and produce reliable trends at multiple points in the process train (powder feeders, wet granules, dry granules) to determine which powder properties are critical-to-quality in generating the desired tablet properties. In this study two formulations were studied to demonstrate how to use improved understanding of granule properties to develop the design space of a continuous manufacturing process.
Emerging Market Capital Sourcing
Speaker: Kevin Batche, Sr. Procurement Manager, IPS – Integrated Project Services
Evaluated from an operations standpoint rather than a technical standpoint, this webinar looks at common fears as they relate to sourcing process and packaging equipment from emerging markets. Of primary concern are the risks associated with material segregation, cross-contamination, test reports, qualification documentation, as well as parts and service after start-up.