Click on a webinar title to see additional details and video link.
- A Broad Activity Screen in Support of a Chemogenomic Map for Kinase Signaling
Presented by: Kevin J. Harvey, Ph.D., Senior Manager, Research and Development
Abstract:
Topics Covered:
- Novel bioinformatics approaches for selectivity and potency
- A framework for accessing polypharmacology
- Access to this chemogenomics knowledge base through the KinaseProfiler™ Service
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- Using a 3-L Disposable Bioreactor to Increase Your Throughput Development Capacity
Presented by: David Balbuena, Process Development and QC Manager at EMD Millipore
Abstract:
During therapeutic protein process development, it is critical for the process to be efficient and economical, particularly when you have limited capacities. One method to address these concerns is to use a disposable bioreactor, which is designed to greatly reduce turnaround time, enabling operators to focus on other value-added activities. Disposable 3-L bioreactors can provide similar results as glass versions and can also be representative of large scale processing. This webinar will present data that shows how disposable bioreactors can support process development activities. A comparison of disposable 3-L bioreactors, 1250-L stainless steel bioreactors and reusable 3-L bioreactors will be shown.
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- Scalability and Robustness of the Mobius® CellReady Bioreactor Platform
- Bioanalytical Approaches for the Development of Monoclonal Antibody Biosimilars
Speaker: Chris Cox, PhD
Moderator: Jim Hulse, PhD
Abstract:
With imminent expiry of key patents, monoclonal antibodies are a focus for biosimilar development. Assays for measuring drug potency are the cornerstone of quality control and assessment of safety of biosimilar monoclonal antibody products in development. These assays need to be robust and sensitive in order to determine lot-to-lot variability in the manufactured product, assess the impact of process changes on drug quality, assess drug stability and enable comparisons between biosimilars and innovators. Attend this webinar to learn the latest bioanalytical approaches for evaluating biosimilars with respect to corresponding innovator drugs. In addition to describing examples of in vitro characterization, the presentation will explain regulatory guidance for pharmacokinetic and immunogenicity testing of monoclonal antibody biosimilars.
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- Implementation and Validation Considerations for a Virus Pre-Filter
Presented by: Navid Khan, Ph.D.
Abstract:
Improvements in upstream process development often generate complex, high titer process streams, placing considerable demands on downstream processing steps. Protein aggregates in these feeds can influence hydraulic performance of virus filters, significantly impacting process economics. The adoption of a pre-filter can mitigate these negative effects, and as a result, the use of pre-filters is rapidly increasing.
Please join Navid Khan, Technology Manager for Viral Clearance, for this webinar in which you will learn about the pre-filters typically implemented, modes of operation, and impact on process development and virus validation, including considerations and best practices for virus spiking.
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- Filter Integrity Testing Best Practices
Presented by: Randy Wilkins, Technical Consulting Team Manager, EMD Millipore
Abstract:
Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility. Where sterility will be claimed, regulatory agencies worldwide require that the sterilizing-grade filter(s) be integrity tested to ensure filter performance is verified prior to and after filter use. Therefore, successful filter integrity tests are a critical link between your filter validation and current processing. This webinar highlights best practices and key considerations for performing filter integrity tests to give you a better understanding of how to design a robust integrity test operation in your own facility.
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- Essentials in Reliable Quality of Dry Powder Mammalian Cell Culture Media: Raw Materials and Production Process Development.
Presented by: Dr. Jörg von Hagen
Abstract:
Please join Dr. Jörg von Hagen, Head of Process Development for Research & Development, as he addresses current bottlenecks in media & feeds.
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- Sterile Filtration Validation Best Practices
Presented by: Ross Acucena, Regulatory Consultant, Services and Solutions
Abstract:
Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed. However, specific guidelines regarding the length of time a filter can be used or the number of batches a filter can produce are not well defined. This webinar will provide recommendations for a well designed approach to validating filter use for multiple batches or extended processing time. Join us as we elucidate these guidelines and recommend a practical approach to validation which balances processes efficiency and risk.
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- Ubiquitination, E3 Ligases and Drug Discovery: Novel Technologies and Services for Unlocking a Challenging Pathway
Presented by: Neil Wilkie, PhD, Chief Scientific Officer, UB Pharma Ltd.
Abstract:
Inappropriate regulation of ubiquitination pathways is linked with a number of human diseases, and components of these pathways are new and unexploited targets for drug discovery. However, exploration of these pathways has been hindered by their complexity and the lack of suitable screening technology.
In this webinar, Dr. Neil Wilkie, CSO of UB Pharma, Ltd., discusses recent breakthroughs in drug discovery within the challenging ubiquitin-proteasome pathway. The discussion showcases the work of the biopharmaceutical company, UB Pharma, as well as EMD Millipore’s UbiquitinProfiler™ service, which provides unique solutions to ubiquitin pathway drug discovery.
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- Nucleo-Mitochondrial Interaction in Apoptotic Cell Death
Presented by: Chandra Mohan, Ph.D., EMD Millipore
Abstract:
Apoptosis can be divided into three stages: a pre-mitochondrial phase involving activation of damage pathways; a mitochondrial phase with loss of mitochondrial functions; and a post-mitochondrial phase where proteins released from the mitochondria activate caspases and nucleases to effect programmed cell death. Pro-apoptotic Bcl-2 family members associate with mitochondria and direct the release of cytochrome c, which binds to cytosolic Apaf-1 to form the apoptosome and activate pro-caspase-9. High cytosolic Ca2+ contributes to opening of the mitochondrial permeability transition pore, which depolarizes mitochondria, dissipates the electrochemical gradient (ΔΨm), and uncouples the respiratory chain. Concurrent rupture of the outer mitochondrial membrane causes the release of AIF, which activates caspase-3 and induces DNA fragmentation. Simultaneously, Smac/DIABLO, released from the mitochondria, binds to and blocks several apoptosis inhibitors. Some of the factors that mediate DNA damage in apoptosis are proteins that transmit apoptotic signals out of the nucleus; for example, Nur77/TR3, a nuclear messenger, translocates to the mitochondria, binds to Bcl-2 and exposes its pro-apoptotic BH3 domain. This presentation will describe several mitochondrial and nuclear factors in apoptosis and highlight methods to study membrane, mitochondrial, and nuclear events in apoptosis.
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- Flow Cytometry Analysis of Clinical Trial Samples
Duration: 1 hour
Presented by: Kevin Maskell, Bioanalytics Project Manager, EMD 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 watch our webinar, 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, EMD 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, EMD 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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- 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
Duration: 1 hour
Presented by: Sal Giglia, Principal Applications Engineer
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?
Duration: 1 hour
Presented by: Mark Blanchard, Research Fellow
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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- Novel Strategies for Inducing Pluripotency and Analyzing Differentiation
Note: This archived webinar will require you to fill out a simple registration form before you launch.
Duration: 1 hour
Presented by: Dr. Vi Chu, Ph.D
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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- Chronic Inflammation: A Causative Factor in Tumorigenesis and Metastasis
Note: This archived webinar will require you to fill out a simple registration form before you launch.
Presented by: Chandra Mohan, Ph.D., EMD Millipore, San Diego, California
Abstract:
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 EMD 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, EMD Millipore
Abstract:
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: EMD Millipore’s Patented Binary Gas Test for Viresolve® Pro Filters
Presented by: Sal Giglia, Principal Applications Engineer, EMD Millipore
Abstract:
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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- Visualize Neural Systems: New Tools For Quantifying and Imaging Neuronal Structure, Function, & Degeneration
Note: This archived webinar will require you to fill out a simple registration form before you launch.
Presented by: Kevin Long, Ph.D., Scientist, EMD Millipore, Neuroscience
Abstract:
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, EMD Millipore
Abstract:
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
Abstract:
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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- Parvovirus Filter Validation: Efforts to Improve and Optimize
Part 1: Parvovirus Filter Validation: Efforts to Improve and Optimize
Presented by: Paul Genest, Engineering Consultant
Part 2: Spike Right: TrueSpike™ Virus Preparations for Virus Filter Validation
Presented by: Dr. Damon Asher, Senior Scientist, EMD Millipore
Abstract:
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
Abstract:
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
Part 1: Improved Method for Screening & Sizing
Presented by: 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
Abstract:
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.
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- Cell Signaling Webinar Series
Note: These archived webinars will require you to fill out a simple registration form before you launch.
Advanced Quantitative Cell Signaling Analysis: MILLIPLEX® MAP EpiQuant™ Technology
The Power of Multi-parameter Phopho Flow Cytometry Approach for Cell Signaling
Presented by: Matthew H. Hsu, Ph.D. , R&D Director, EMD Millipore
Cell Signaling in Space and Time
Presented by: John D. Scott, FRS, Professor, Univ. of Washington School of Medicine
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- Fill Finish 101: Introduction to Implementing a Single Use Solution
Presented by: Ernie Jenness, Product Manager, EMD Millipore
Abstract:
Please join us as we discuss key considerations when implementing a single-use fill/finish operation and how it can meet today's increasingly complex drug production demands.
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- Improving the Accuracy of Membrane Filters Scale-up
Presented by: Sal Giglia, Principal Applications Engineer, EMD Millipore
Abstract:
Join us as we highlight key principles for reliable scale-up of microfiltration devices and present new advances in scaling methodologies for filtration of biological liquids.
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- Introduction to Flexible Filtration: A Strategic Approach to Implementing Single-Use Technology Using Lean Manufacturing Principles
Presented by: Vikas Gupta, Group Product Manager, Downstream Processing
Abstract:
The webinar explains the lean manufacturing waste categories in the context of single-use manufacturing. Learn how flexible filtration can meet fast-changing product, site and scale requirements by bringing together ready-to-use, right-out-of-the-box single-use systems, featuring modular, fully optimized assemblies that are simple to set up. These systems use only what is needed, are replicable, scalable and designed to facilitate technology transfer across multiple sites.
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- Factory of the Future: Two-Part Chromatography Webinar Series
Part 1: The Methodology of Sizing and Scaling a Novel Flow-through Anion Exchanger Designed to Remove Impurities at High Salt Concentrations
Presented by: Conrad Maher, Product Manager
Part 2: Improving the Cost Effectiveness and Productivity of MAb Capture Processing
Presented by: Helen Wood, Product Manager and Jerrod Einerwold, Chromatography Media Specialist
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- Protect Your Process from Mycoplasma Contamination. What are you willing to risk?
Presented by: Kerry Roche Lentine and Martha Rook, PhD
Abstract:
This presentation covers key considerations when implementing the three cornerstones of a Mycoplasma risk mitigation program: prevention, clearance and detection.
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- Novel vaccine adjuvants: What is the future? What are the challenges?
Presented by: Dr. Christina Carbrello
Abstract:
Adjuvants comprising oil-in-water emulsions and liposomes are becoming more common in formulations as a cost effective way to meet world-wide vaccine demand. Regulatory requirements dictate that the drug product be provided sterile, and adjuvant emulsions and liposomes are known to be difficult to validate for capacity and bacterial retention. To advance the development of robust filtration solutions for these complex streams, studies were taken to understand the factors that impact capacity and bacteria retention during the filtration of emulsions and liposomes.
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- Risk-based Assessment of Extractables & Leachables in Single-Use Systems
Presented by: Vikas Gupta
Abstract:
Join Vikas Gupta as he takes a closer look at various risk-based approaches, including some that may even make the identification of extractables and leachables unnecessary.
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- EMD Millipore´s Pandemic Preparedness Webinar
Presented by: Robert Shaw, Maurice Phelan
Abstract:
Please join us for a 60-minute webinar presenting the latest information on EMD Millipore’s Pandemic Preparedness Plans.
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- PDA Technical Report No. 26 (TR-26)
Presented by: Maurice G. Phelan
Abstract:
The new TR-26 provides a systemactic approach to selecting and validating the most appropriate filter for liquid-sterlizing filtration applications. Please watch our 90-minute webinar.
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