Virus Safety Videos & On-Demand Webinars

Oct | 2017

• Presenter: Martin Wisher, Senior Director, Global Head of Regulatory Affairs, BioReliance® Services
• Abstract

  This webinar will present regulatory requirements for cell bank and virus seed characterization from different organizations worldwide. Learn about new technologies for determination of cell substrates & virus seed stocks and detection of agent contamination.
  
  The characterization of cell substrates, virus seed stocks and virus harvests, used in human vaccine production, for identity and purity is required by regulators worldwide. This presentation will give you an overview of the regulatory requirements given in the latest guidance documents from the US FDA, WHO, European Pharmacopoeia and ICH. It will highlight differences between these documents and describe new technologies for determining the identity of cell substrates and virus seed stocks as well as detecting adventitious agent contamination.
  
  In this webinar, you will learn:

  • about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
  • the difference between guidance documents from different organizations worldwide
  • new technologies for determining the identity of cell substrates and virus seed stocks
  • detecting adventitious agent contamination

Sept | 2017

• Presenter: Mathilde Bourguignat, Biomanufacturing Engineer
• Abstract

  New membrane technology enables cost-effective and easy-to-use virus filtration of cell culture media and other upstream components.
  
  Biopharmaceutical manufacturing requires a multilayered approach to virus safety to minimize the risk of contamination. Despite careful sourcing and testing of raw materials, there remains a risk of introducing virus into bioreactors, which could impact manufacturing operations and cause significant business disruption.
  
  This webinar will discuss implementation of a novel virus filter as part of an upstream virus safety strategy. This filter is specifically designed to filter cell culture media and other upstream components without impacting cell culture or media composition. This point-of-use operation is easy to implement and reduces the risk of introducing virus into a bioreactor, as a last line of defense.
  
  In this webinar, you will learn about:

  • Upstream virus filtration as a novel means of mitigating risk of bioreactor contamination
  • Methods of ensuring that a new upstream technology has no negative effect on cell growth or protein quality
  • How an optimized membrane contributes to high throughput and process economics

Sept | 2017

• Presenter: Alison A. Armstrong, PhD, Senior Director, Global Head of Field Development Services
• Abstract

  Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
  
  Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
  
  From cell culture seed train to final fill vial, this presentation will describe:

  • Potential risks associated with different areas of biotech processes
  • What can be done to minimize adventitious virus risk in those areas.

  The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.

Aug | 2017

• Presenter: Jeffrey Hartnett, Senior Product Manager - Virus Safety Solutions
• Abstract

  Learn how QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, allowing the development of a streamlined validation approach and robust process control strategy for virus clearance via filtration.
  
  ICH Q8 defines Quality by Design (QbD) as “…a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” Within the context of virus clearance for bioprocesses, QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, guiding the development of a streamlined validation approach and robust process control strategy for virus clearance unit operations. We will explore how QbD principles can be applied to downstream virus filtration of mAbs and recombinants, explore the application of these principles within the framework of the Viresolve® Pro Device (parvovirus retentive filter) and outline the benefits that can be gained through simplifying the validation strategy and increasing the robustness of your regulatory filing package.
  
  In this webinar, you will learn:

  • How to simplify validation study design
  • Identify critical process and feed parameters affecting virus retention
  • How to compile a robust regulatory filing package

March | 2017

• Presenter: Dr. Paul Beckett, Technology Manager Life Sciences, EMEA
• Abstract

  The tendency for most biological products to self-associate and aggregate, often irreversibly, is a considerable challenge in process management and design, as aggregated product leads to patient safety concerns, process challenges and lost yield. Therefore, it is important to reduce the aggregation of the biological product during processing and to remove aggregates efficiently and effectively.
  
  In this webinar you will learn:

  • How and why biological product aggregates form within a bioprocessing environment, based on process conditions and biochemistry, and how these are detected
  • Strategies for reducing the risk of aggregation at each stage of the process
  • Proven methods for removal of aggregates effectively

March | 2017

• Presenter: Guillaume Plane, Management and Development Manager, Merck
• Abstract

  The Webinar will focus on what should be considered in order to make the best choice to develop one given biosimilar instead of another. Secondly, we will consider the main requirements to be successful in delivering such a biosimilar on the market.
  
  With patents expiring on many established big biologic drugs, biosimilars have become increasingly tantalizing opportunities for manufacturers over the past ten years. The Webinar will focus on what should be considered in order to make the best choice to develop one given biosimilar instead of another. Secondly, we will consider the main requirements to be successful in delivering such a biosimilar on the market.
  
  In this webinar you will learn:

  • Why and how to prioritize between biosimilars in development
  • How to be successful in developing a biosimilar
  • How to be successful in launching a biosimilar on the market

Nov. | 2016

• Presenter: Jaime De Souza, Process Development Scientist, Merck
• Abstract

  Parvovirus retentive filters are a commonly implemented and validated viral clearance technology within bioprocesses (mAb/recombinant and plasma fractionation). Regulatory guidance stresses that viral clearance filter validations be as representative of full scale manufacturing as possible to ensure the validity of the study results. There are a number of critical factors to consider during validation which can present challenges in maintaining this representativeness. If these factors are not properly addressed in the study design, retention and/or capacity could be negatively impacted.

  This webinar will guide you through best practices to adopt for spiking studies to ensure the highest levels of success and filter performance. Specific considerations to be discussed will include: effect of freeze/thaw/aging/shipping/handling on feed, decoupling adsorptive prefilters, virus prep purity and spike percentage, constant flow vs. constant pressure operation and process interruptions.

  In this webinar you will learn:

  • Critical factors which can impact the success of a spiking study
  • Best practices to ensure the highest levels of success and filter performance

Nov. | 2016

• Presenter: Michael Felo, Director Mobius Single-Use, Merck
• Abstract

  Single-Use systems, enabling faster more cost effective bio-pharma manufacturing, must also meet high quality parameters and standards while conducting component qualification, manufacturing operations, inprocess testing, and final product release.

  For single use systems, quality control during the manufacturing process is critical. In a traditional stainless-steel system, the end user has significant control over the design, construction, qualification and validation, and maintenance of the system. When implementing a single-use system, the supplier of the single use product takes responsibility for many of these functions from the user. It is therefore important that the single use supplier has established and follows a strong quality control system. This presentation will highlight the quality systems, processes, facilities, and personnel required to assure the performance, robustness, and sterility of single use systems.

  In this webinar you will learn:

  • The process used to qualify components, suppliers and sub-suppliers
  • Managing documentation control, change control, process particulate control, risk mitigation practices
  • See examples of Extractables Testing, Validation of MFG processes, MFG Controls, Sterilization Qualification, Realease Testing and Certification, Integrity Assurance

Sept. | 2016

• Presenter: Dr. Alison Armstrong, Senior Director, Global Head of Field Development Services, Merck
• Abstract

  The requirements for the quality control (QC) of biological medicinal products are defined in guidance documents produced by regulatory agencies and international organisations such as EMA, US FDA, Japanese PMDA, ICH and WHO. Although these guidance documents are revised periodically, these revisions usually lag behind scientific advances and technical innovations.

  This webinar will describe a number of topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments will be discussed.

  Topics that will be covered include:

  • Current and new approaches to genetic stability and clonality determinations
  • New approaches to cell line identity testing
  • Spiroplasma testing
  • Evaluation of in vitro and in vivo assays for extraneous agent detection and replacement of in vivo assays
  • Recommendations for the virus evaluation of Investigational Medicinal Products (IMPs) from EMA and US FDA

Sept. | 2016

• Presenters:
  
  • Session 1: Ranjeet Patil, Technology Manager, Merck
  • Session 2: Ben Cacace, R&D Engineer, Merck
• Abstract

  Size exclusion based filtration provides critical viral clearance assurance in most established and new biopharmaceutical production processes. Although process intermediates are highly purified prior to viral clearance filtration, the presence of protein aggregates, denatured proteins and other trace fouling species can negatively impact the hydraulic performance of virus filters, increasing the required filter area and costs.

  In this webinar, we will:

  • Provide guidance on the proper selection and use of prefiltration across several technologies for optimal operation of high performance virus filters
    
    
  • Look at the underlying mechanisms of virus filter fouling and prefiltration that will provide the background for making rational decisions in process development and optimization
    
    
  • Give examples with monoclonal antibody feed streams and an IgG model feed that demonstrate the dramatic improvements in throughput that can be achieved across multiple molecules at a wide range of pH and conductivity by implementing adsorptive based prefiltration.

Jan. | 2016

• Presenter: Kenneth Muzykewicz, Director of Membrane Process and Technology, Merck
• Abstract

  Changes happen. Suppliers go out of business. Plants consolidate. Drug product lifecycles exceed the lifecycles of the raw materials on which they’re reliant. We are committed to controlling, managing and communicating changes in the most stringent and highest quality manner to ensure your security of supply. In this webinar, Kenneth Muzykewicz will provide you with an overview of our change control process for critical raw materials within our filters.

  Join us for this webinar as we will focus on our:

  • Validation strategy & philosophy
  • Step by step approach to validation
  • Success criteria

  And learn how we:

  • Demonstrate no adverse effect on product performance
  • Define equivalence
  • Minimize the impact of change on your process

April | 2015

• Presenters: Thierry Burnouf, Ph.D., Taipei Medical University, Taiwan and
  Eric Youssef, Plasma Market Leader, Europe and Asia, Millipore SAS, France
• Abstract

  Biomanufacturing of plasma-derived products requires at least two orthogonal virus reduction steps to comply with regulatory pathogen safety risk mitigation guidelines. Solvent detergent viral inactivation (SD VI) has historically been effectively utilized for the inactivation of lipid-enveloped viruses from plasma derived products, yet only recently have process development activities focused on implementation of SD VI in single use systems. The adoption of single-use technologies for bioproduction continues to progress, driven predominantly by the benefits of operational flexibility, speed of implementation, lower capital investment, and elimination of cross contamination concerns. However, the suitability of this flexible production platform for SD VI remains to be fully characterized.
  
  This presentation will review data generated on a single-use mixing platform that demonstrates successful performance of this operation in a flexible manufacturing environment. Specifically, chemical compatibility, non-specific chemical adsorption, and leachables profiles of the reagents used in SD VI with the container assemblies will be reviewed. In addition, the effectiveness of inactivation, based on small scale virus spiking studies, will be presented. Finally, the potential impact on protein quality and activity will also be discussed.

Sept. | 2014

• Presenter: Damon Asher, Head of Process Safety and Control, Merck
• Abstract

  Bioreactor contamination from virus is a persistent threat despite current best practices. Virus detection testing and virus clearance operations may be used in combination to achieve a desired overall risk profile. In this presentation, we discuss new methods for the modeling, quantification and control of contamination risk. These tools can be used to guide the design of rational biosafety strategies and inform the development of new technologies for bioreactor protection.

Oct. | 2013

• Presenter: Ashley Slocum, Biomanufacturing Engineer, Merck
• Abstract

  Virus filtration is a dedicated step for biopharma. Recent work has shown that virus removal of some virus filters is compromised by process interruptions. This webinar studies the impact of process interruptions on the performance of virus filters.

Oct. | 2013

• Presenter: Sal Giglia, Principal Applications Engineer, Merck
• Abstract

  Liquid-liquid porometry (LLP) is a method for characterizing the pore size distribution of porous structures. In this work, pore size distributions of developmental and commercial virus filtration membranes spanning a range of pore size distributions were measured with an automated high resolution LLP test system customized for virus filter membranes. Using these pore size distributions determined from LLP, a mechanistic model grounded on the principle of particle retention by size exclusion closely predicted measured virus retention performance, both as a function of virus size and of membrane pore size. The data and model predictions from this study support the understanding that size exclusion is the primary mechanism for virus retention in membrane filters. An abridged LLP test, which is focused on a critical portion of the pore size distribution, was developed for the Viresolve® Pro membrane and is utilized at-line during membrane casting to assure consistent membrane pore size and therefore consistent virus retention.

June | 2012

• Presenter: Navid Khan, Ph.D., Technology Manager, Viral Clearance, Merck
• 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.

Dec. | 2011

• Presenter: Willem Kools, Director, Biomanufacturing Science Network, Merck
• 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.

Nov. | 2011

• Presenters: Sal Giglia, Kevin Rautio, and Mikhail Kozlov, Merck
• 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.

April | 2011

• Presenter: Sal Giglia, Principal Applications Engineer, Merck
• 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.