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 | Flow Cytometry Analysis of Clinical Trial Samples
Duration: 1 hour
Presented by: Kevin Maskell, Bioanalytics Project Manager, Millipore
Abstract:
Flow cytometry, a multiparameter technique applied to pharmacodynamic analysis in clinical studies, can provide an enormous amount of cost effective, precise data that is relevant to mechanisms of action. Data interpretation, however, is complex and sound scientific knowledge is required from the initiation of the clinical study including sample collection considerations, reagent sourcing, quality control procedures and data analysis rules.
We invite you to attend our webinar, including a live Q&A session, where we will discuss strategies to prevent anomalous and misleading reporting, important if planning assays in-house, and essential if outsourcing to a service provider.
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 | Characterization and Performance of the Mobius® 200L CellReady Bioreactor System: Novel Monitoring Technology and Comparison Between Scales and Systems.
Duration: 1 hour
Presented by: Lee V. Madrid, PhD., Consulting Engineer, Millipore
Abstract:
Upstream processing in the Biopharmaceutical industry is shifting to single-use bioreactors because of the advantages they have over traditional stainless steel bioreactors. To be successful, single-use bioreactor systems must be able to accurately and effectively monitor and control critical process parameters. In this regard, the Mobius® CellReady 200 L single-use bioreactor is uniquely designed with the novel Mobius® SensorReady technology, an external loop that enables configurable, flexible and functional monitoring and control. Bioreactor characterization properties such as mixing time, volumetric mass transfer capabilities, temperature mapping and power input define the process design space wherein accurate and effective monitoring and control can occur. Each of the aforementioned characterization properties were explored and evaluated for the Mobius® CellReady 200 L single-use bioreactor system. Mixing studies were performed using conductivity probe response curves and comparing samples drawn from the Mobius® SensorReady module compared to samples drawn from the bulk liquid. Mass transfer capabilities were studied using the static gassing out method for determining the volumetric mass transfer coefficient (kLa) for oxygen and by the demonstration of CO2 stripping in live cell culture material using the microsparger and open pipe sparger, respectively. Heating and cooling capabilities were measured during ramp up and ramp down cycles, and power input was determined based on the wattages measured within the agitator motor box over varying agitation rates. In addition to physical characterization, cell culture capabilities were demonstrated with the execution of multiple cell culture processes achieving peak cell densities > 20e6 cells/mL, with growth and metabolic behavior comparable to 3 L scale down controls. We have also compared different single-use systems and scales and found robust comparability between them.
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 | Process development towards a robust and economical virus filtration process
Duration: 1 hour
Presented by: Willem Kools, Director, Biomanufacturing Science Network, Millipore
Abstract:
Understanding virus filtration in all its operational aspects is an important piece of designing a robust and economical process.
Economic analysis of virus filtration is often only based on filter sizing followed by a simple calculation to include filter cost per area of the selected filter.
An alternate way of looking at economics is to include an analysis on economically rationalized safety factors which include feed, process and membrane variability as well to include costs associated to set-up, processing and product recovery.
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 | Improving the capacity of virus filtration membranes by robust pre-filtrations
Duration: 1 hour
Presented by: Sal Giglia, Kevin Rautio, and Mikhail Kozlov
Abstract:
Membrane filters designed for virus filtration contain pores sized to exclude the passage of virus particles while allowing for high passage of target proteins. In some feed streams, however, the presence of protein aggregates, denatured proteins, and other impurities can plug the membrane pores and compromise throughput capacity. For these streams, pre-filtration or pre-conditioning can enable dramatic increases in virus filter capacity and ensure against the effects of feed stream variability. This talk will discuss the role and performance of pre-filters in virus filtration, and explore the mechanisms by which virus pre-filters operate. An understanding of the principles underlying pre-filter performance can aid in the proper selection and implementation of virus pre-filters.
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 | The Impact of Cellular Signaling on Successful Drug Development
Duration: 1 hour
Presented by:
Blaine N. Armbruster, Ph.D., Strategic Marketing Manager, Lead Discovery, Millipore
Abstract:
Aberrations in cell signaling, often resulting from mutations or overexpression of signal transduction proteins, are responsible for a host of diseases including cancer, inflammatory and metabolic diseases. Many drug targets, like kinases, are involved in signal transduction. While it has been relatively easy to develop biochemically potent compounds the translation of these compounds into efficacious drug in more complex biological models remains a challenge. Part of the reason for this is the complexity in cellular signaling itself. Although, there has been a basic understanding of basic signaling pathways for decades, it is only recently that we have come to appreciate that the redundancy, cross-talk and feedback in these pathways presents an obstacle to drug discovery. Examples highlighting the importance of signaling on cellular drug activity along with a case study comparing biochemical activities and cellular activities of market kinase inhibitors will be presented in this webinar.
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 | Next generation bioanalysis using the Gyrolab® platform.
Development of validated biomarker and immunogenicity assays for clinical studies.
Duration: 1 hour
Presented by:
Medha Kamat, PhD, Senior Research Scientist, BioPharma Services
Mark Abrams, Research Scientist III, BioPharma Services
Abstract:
Development of immunoassays can be streamlined by use of the Gyrolab platform, which uses parallel technology to speed up the screening of optimal antibody pairs. Using the Gyrolab platform, we can screen multiple antibody pairs under multiple assay conditions simultaneously, more rapidly than by other methods. We recommend instrument and assay best practices for Gyrolab users and show how this platform yields sensitive, robust cytokine assays for regulated bioanalysis. This webinar will also provide an overview of screening for antibodies for immunogenicity studies.
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 | Process Development Best Practices: Optimizing normal flow membrane filters operated in series
Presented by: Sal Giglia, Principal Applications Engineer
Duration: 1 hour
Abstract:
The traditional method for sizing normal flow filters operating in series has been shown to be inefficient and inadequate in applications where filter sizing is flow rate dependant. For filters operating in series at constant inlet pressure, each filter in the filtration train operates and generally fouls at different rates. Filter sizing models that do not account for the effect of flow rate on the rate of filter fouling will not properly simulate serial filtration behavior. As a result, filter train sizing estimates can be skewed and unbalanced between the initial filter and the final filter, leading to lower than expected serial filtration performance.
Join us as we share best practices for optimal filter sizing using a model and method that improves the accuracy of sizing membrane filters operated in series. In addition, we will demonstrate how to use this model for rapid and efficient optimization of prefilter to final filter area ratios.
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 | Quality by Design Principles in Aseptic Processing: Have you minimized your sterile filtration risk?
Presented by: Mark Blanchard, Research Fellow
Duration: 1 hour
Abstract:
In aseptic processing of pharmaceutical products, it is critical that drug products are free from bacteria and other microorganisms to ensure patient safety. Sterilizing-grade filters are commonly used to meet this requirement.
Join us as we review different approaches to sterile filtration including: nominal pore size ratings and log reduction values (LRV). We will describe an approach to selecting an effective and efficient sterilizing filter and will show how this approach is in alignment with quality by design (QbD) principles.
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 | Note: This archived webinar will require you to fill out a simple registration form before you launch.
Novel Strategies for Inducing Pluripotency and Analyzing Differentiation
Presented by: Dr. Vi Chu, Ph.D
Duration: 1 hour
Abstract:
For studying differentiation pathways or exploring therapeutic potential of pluripotent cells, it helps to have a ready source of induced pluripotent stem cells (iPS cells). iPS cells are more convenient and reliable than embryonic stem cells, which may be more heterogeneous, hard to culture, and subject to regulation. iPS cells were originally generated by introducing four vectors (each carrying one of four transcription factor transgenes) into somatic cells. Recently, a single lentiviral vector was generated which enabled the expression of the four transcription factors from a single multicistronic transcript.
In this webinar, we show that expression of this “stem cell cassette” (STEMCCA) was able to efficiently reprogram mouse embryonic fibroblast (MEF) and human foreskin fibroblasts (HFF) into iPS cells. We will also describe novel tools that help (1) distinguish and select fully reprogrammed colonies from mixtures of partially reprogrammed cells, (2) quantify viral transgene silencing in iPS cells and their differentiated progeny, (3) excise the transgenes in a STEMCCA system and (4) chemical strategies to increase reprogramming efficiency. The use of a single lentiviral vector rather than 4 separate vectors significantly reduces the risk of insertional mutagenesis and viral reactivation and is a step towards safer and more effective utilization of iPS technology for clinical therapies.
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| Design Considerations & Best Practices for Tank Vent Filtration
Presented by: Mike Felo, Applications Engineer Consultant
Abstract:
Improper vent design can result in low flow rates, frequent change-outs, higher operation costs and increased risk for the application. Fortunately, a proper vent design can be achieved as long as the flow requirements, operating condition, system design and risk levels are understood.
Join us as we highlight best practices and key design considerations for vent filtration applications while reducing costs. Discover how to mitigate common issues encountered in day-to-day vent filtration operations, and learn more about regulatory requirements, risk management considerations and integrity testing.
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 | Note: This archived webinar will require you to fill out a simple registration form before you launch.
Chronic Inflammation: A Causative Factor in Tumorigenesis and Metastasis
Presented by: Chandra Mohan, Ph.D., Millipore, San Diego, California
Although free radicals produced during inflammation help to eliminate pathogens, excess free radicals can damage biomolecules, leading to malignancy. The inflammatory link to carcinogenesis is supported by the fact that NF-κB signaling is dysregulated in several human cancers, protecting cancer cells from apoptosis and potentially enhancing proliferation. Therefore, blocking NF-κB activity has great therapeutic potential. This webinar will present findings linking chronic activation of NF-κB to tumorigenesis and new research products developed by Millipore for investigating pathways involved in chronic inflammation and cancer.
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 | Improving the Consistency of Virus Filtration Membrane Performance by Selective Layering
Presented by: Sal Giglia, Principal Applications Engineer, Millipore
Consistency in device-to-device performance is critically important for membrane filtration devices users. In the case of virus filtration, important performance criteria include throughput capacity, flux (or permeability), and retention of viruses. Device performance variability may depend on a number of factors, but variability of the membrane used to make the devices is fundamental. In multi-layer devices containing similarly rated membrane in each of the layers, each layer within the device contributes to performance. However, the contribution of each layer may not be equal, especially for throughput capacity, which tends to be controlled by the upstream layer.
In this work, a selective layering strategy was employed for double-layer virus filters in which the top and bottom layers were selected from different segments of the normal membrane population, and optimally paired such that device-to-device throughput performance variability was reduced by about half compared to random pairing, while average throughput performance increased. Because membrane throughput performance correlated with membrane permeability and membrane virus retention, consistency of these two performance parameters was also demonstrated to significantly improve by employing the selective layering strategy.
During this webinar, you will learn more about the principles behind a novel method used to ensure consistent performance of the industry’s leading virus filter.
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 | Ensuring Integrity of Virus Filtration Devices:
Millipore’s Patented Binary Gas Test for Viresolve(R) Pro Filters
Presented by: Sal Giglia, Principal Applications Engineer, Millipore
A novel non-destructive integrity test for virus filters has been developed that is far more sensitive to detecting defects than a conventional gas-liquid diffusion test. The test uses a binary gas mixture and is based on the principle of different gas permeabilities through the liquid layer that results in an increased concentration of the faster permeating gas. In an integral membrane, the permeate composition can be predicted based on the transport properties of the gases permeating through the liquid layer and the known operating conditions. A deviation from the expected concentration is an indication of the presence of a defect or open pores. Unlike the gas-liquid diffusion test, the binary gas test has low sensitivity to membrane porosity, liquid layer thickness, and membrane area. Consequently, integral devices will exhibit a relatively narrow range of integral values, resulting in a superior defect signal-to-noise ratio. The binary gas test was demonstrated to provide a significantly higher level of virus retention assurance compared to the air-water diffusion test.
This talk will elaborate on the principles of commonly applied virus filter integrity tests and present new advances in virus retention assurance for virus filters.
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 | Note: This archived webinar will require you to fill out a simple registration form before you launch.
Visualize Neural Systems: New Tools For Quantifying and Imaging Neuronal Structure, Function, & Degeneration
Presented by: Kevin Long, Ph.D., Scientist, Millipore, Neuroscience
Breakthrough neuroscience research requires integrated analysis of cytoarchitecture, cell types, and tissues using diverse techniques. Juxtaposed with new high-tech imaging, classic immunodetection-based techniques continue to drive neuroscience research. New advances in neuronal culturing platforms combined with novel antibody-based and chemical staining tools have made it possible to study neural structure, function, and dysfunction with high precision and sensitivity. Join us for a live webinar introducing new, powerful tools for imaging and quantifying neuroscience.
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 | Improved Method For Animal Free Single Cell Cloning
Presented by: Janmeet Anant, Ph.D., Product Manager, Animal Free Cell Culture Supplements, Millipore
This presentation will cover basic concepts of single cell cloning goals, current best practices, along with advantages and limitations. You’ll learn approaches to quickly screen a variety of clones for attributes critical for your cell line selection and further process development goals.
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 | Design of a TFF System Utilizing a Single-Use Flowpath to Achieve Optimal Process Performance
Presented by: Elizabeth Goodrich, Applications Engineering Manager
Successful implementation of single-use process-ready hardware systems requires more than realizing the benefits of rapid facility startup, operational flexibility, and elimination of cleaning validation. Key success criteria of high product yield, quality, purity, and robustness must also be achieved. Optimization of single-use fluid path designs for each downstream processing unit operation has been completed with these criteria as a central focus. The results of low volume process capability, diafiltration effectiveness, and product recovery for a single-use TFF system will be presented.
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 | Part 1: Parvovirus Filter Validation: Efforts to Improve and Optimize Presented by: Paul Genest, Engineering Consultant
Part 2: Spike Right: Ultrapure Virus Preparations for Virus Filter Validation
Presented by: Dr. Damon Asher, Senior Scientist, Millipore
Join us for one or both of our new webinars, aimed at providing you with relevant information on the latest progress in virus filtration.
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 | Chromatin Immunoprecipitation: Improved Approaches for the Analysis of Epigenetic Regulation at Single Loci and Genome-Wide.
Presented by: Dr. John Rosenfeld
In recent years, epigenetics has transformed from a specialized field to a paradigm of gene regulation, applicable across diverse research areas. Epigenetic changes such as DNA methylation, post-translational modifications of histones, and subsequent chromatin remodeling have been shown to play crucial roles in transcriptional regulation of most genes. Join us as John Rosenfeld, an expert in ChIP, will present the crucial information that will enable you to immediately benefit from strategies for executing more successful ChIP experiments. This presentation will cover basic concepts of ChIP and advances in technology, including genome-wide profiling. You’ll learn approaches to assay design, performance, and data analysis to help avoid the most common and some uncommon experimental pitfalls.
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 | Factory of the Future: Two-Part Clarification Webinar Series
Join us for a two part series to learn how you can improve your clarification process. In our first webinar, our subject matter expert will discuss an innovative method for screening and sizing depth & sterile filters. Our second webinar will cover the topic of achieving robustness in your clarification process by using flocculation methods and an optimized dual stage separation technology.
Part 1
Improved Method for Screening & Sizing
Event Speaker: Michael Felo, Applications Engineer Consultant
Part 2:
The Development of a Robust Clarification Process for High Density Mammalian Cell Culture Processes Using Flocculation Methods and an Optimized Dual Stage Separation Technology
Presented by: Sarah Hove, Process Development Consultant
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 | Note: These archived webinars will require you to fill out a simple registration form before you launch.
View Webinar
Advanced Quantitative Cell Signaling Analysis: MILLIPLEX® MAP EpiQuant™ Technology
View Webinar
The Power of Multi-parameter Phopho Flow Cytometry Approach for Cell Signaling Presented by: Matthew H. Hsu, Ph.D. , R&D Director, Millipore Corporation
View Webinar
Cell Signaling in Space and Time
Presented by: John D. Scott, FRS, Professor, Univ. of Washington School of Medicine
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