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Life Sciences

  • More Success in LC-MS: Tips and Tricks for Sample & Mobile Phase Preparation
    More Success in LC-MS: Tips and Tricks for Sample & Mobile Phase Preparation
    Vivek Joshi, PhD Recorded: Nov 15 2018 46 mins
    LC-MS is one of the most commonly used analytical techniques in various sectors for quantitation and identification of unknown from variety of complex samples. Use of LC-MS has expanded over the years as it offers both selectivity and specificity in analysis. With advances in both chromatography and mass spectrometry, sensitivity and accuracy of this technique has further increased, allowing for detection and identification of low-level analytes in complex sample matrices.

    The LC-MS workflow has three main components, which determine successful analyses: sample preparation, choice of mobile phase components and column selection. Not paying enough attention to one of these components can complicate data analysis, quantitation and identification.

    In this seminar, you will learn critical factors to consider when selecting the sample preparation methods, mobile phase components and HPLC columns.
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview
    Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Recorded: Nov 15 2018 42 mins
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • ¿Por qué importa la seguridad?  Perspectivas de Latinoamérica de Unisys Security
    ¿Por qué importa la seguridad? Perspectivas de Latinoamérica de Unisys Security
    Leonardo Carissimi, Security Solutions Director, Unisys Latin America Recorded: Nov 14 2018 62 mins
    Unisys Security Index es una importante encuesta regular de las preocupaciones de seguridad llevada a cabo en todo el mundo. Lanzada a nivel mundial desde 2007, proporciona una medida regular y estadísticamente sólida de las preocupaciones que tienen los consumidores de 13 países con respecto a los principales aspectos de la seguridad, incluyendo seguridad nacional, financiera, personal y ciber seguridad.
    Únase a este webinar para escuchar a Leonardo Carissimi, director de Ciberseguridad para Unisys América Latina, compartir los resultados y realidades de la encuesta sobre de las preocupaciones de seguridad de los consumidores en Argentina, Colombia y México.
    Leonardo usará los resultados de este año, yuxtapuestos con más de una década de historial de encuestas realizadas para proporcionar un informe convincente sobre el estado de la seguridad desde la perspectiva que más importa: la del usuario.
  • Por que a segurança importa?  Perspectivas globais e locais do Unisys Security
    Por que a segurança importa? Perspectivas globais e locais do Unisys Security
    Leonardo Carissimi, Security Solutions Director, Unisys Latin America Recorded: Nov 14 2018 63 mins
    Unisys Security Index é uma importante pesquisa sobre preocupações de segurança realizadas em todo o mundo. Lançado globalmente em 2007, fornece uma medida regular e estatisticamente sólida das preocupações que os consumidores em 13 países têm sobre os principais aspectos da segurança, incluindo segurança nacional, financeira, pessoal e cibernética.
    Participe deste webinar para ouvir Leonardo Carissimi, diretor de Segurança Cibernética da Unisys América Latina, compartilhar os resultados e fatos da pesquisa sobre as preocupações de segurança dos consumidores do Brasil.
    Leonardo usará os resultados deste ano, justapostos com mais de uma década de histórico de pesquisas para fornecer um relatório convincente sobre o estado de segurança da perspectiva que mais importa: o usuário.
  • Chatbots & Virtual Assistants - The Next Big Thing in Customer Experience
    Chatbots & Virtual Assistants - The Next Big Thing in Customer Experience
    Teletech Holdings, Booz Allen Hamilton, Opus Research Recorded: Nov 9 2018 61 mins
    Provided with access to the right information chatbots can help facilitate a new transaction or provide account support to an existing customer. Many vendors are claiming to use machine learning and artificial intelligence in their virtual assistant applications. However, the reality is, curated, structured content needs to be developed for these applications, rather than having the system ingest large amounts of unstructured content.

    What makes content appropriate for training? How should organizations prepare for these types of systems? How do the underlying processes that support the customer need to evolve to operationalize AI applications for customer service?

    In this panel, we discuss:

    --The different types of automated virtual assistants used for support

    --How artificial intelligence powers these tools

    --The role of knowledge engineering

    --Practical steps toward deployment

    Join our experts for an in depth discussion of “the next big thing” in customer experience.
  • Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Dr Sourav Kundu, Senior Director at Teva Pharmaceuticals Global Biologics R&D and Adam Kaletski, Business Leader, Bioprocess Recorded: Nov 9 2018 64 mins
    Clinical manufacturing facilities require the flexibility to configure the sequence of unit operations as well as equipment characteristics to fit diverse types of manufacturing processes.

    While stainless steel facilities remain as more traditional and suitable for large volume products, single-use facilities provide tremendous advantage for flexibility, infrastructure and capital costs, and start-up time. 

    Single-use equipment and single-use facilities are particularly suitable for clinical manufacturing due to smaller investment requirements, smaller footprint, reduced risk, and increased operational flexibility. 

    While single-use equipment are evolving and catching up to the functionality and reliability of stainless steel equipment, in some instances, stainless steel equipment may still be preferred. 

    We will be providing a description of a new clinical manufacturing facility where single-use and stainless steel equipment were combined in a strategic manner to meet the business objectives.

    Biopharmaceutical manufacturing facilities are designed and operated to meet business objectives at various stages of a product lifecycles. While large stainless-steel facilities are appropriate for large volume established products, smaller single-use facilities are more efficient for smaller volume manufacturing needs, particularly for clinical supplies. Stainless steel equipment can be combined with single-use equipment to create hybrid facilities to meet process needs and business objectives in a more efficient manner. Typical challenges with building and validating a biopharmaceutical manufacturing facility can be overcome by strategic planning, good execution and a high-performance team.
  • Cell Culture in 3D Systems; Moving from a 2D to 3D Environment
    Cell Culture in 3D Systems; Moving from a 2D to 3D Environment
    Seth Hanson, Academic Research Technology Specialist - Merck KGaA, Darmstadt, Germany Recorded: Nov 9 2018 64 mins
    Cell culture in 3D systems: moving from 2D to 3D cell culture?
    It’s now well accepted by the scientific community that the 3D cell culture condition better recapitulate the in vivo environment and behaviours of cells. But it’s not a trivial change to move from 2D cell culture conditions to 3D, and not always easy to choose the right system to use.

    An understanding of the key parameters for 2D and 3D cell culture will be reviewed, followed by an overview of the technologies available at Merck with features, benefits, and application data.
  • Regulatory Approval of Three Rapid Microbiological Methods for MACI Release
    Regulatory Approval of Three Rapid Microbiological Methods for MACI Release
    John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles River Recorded: Nov 8 2018 65 mins
    Title:Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release
    Rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
    Followed by Data Integrity: Eliminating Risk & Human Error by Utilising Cartridge Technology Presented by Nicola Reid, Senior Product Manager at Charles River – Microbial Solutions
    The human element can never be completely eliminated in Bacterial Endotoxin Testing, but what can be done to mitigate the risk for human error and how does it relate to the data integrity problem?
    Reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and thus keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety.
    We’ll apply those principal to an invalid BET example to see how the result can potentially cripple your manufacturing timelines. There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and advances in science have allowed for improvement in how it’s utilized. The end result is the revolutionary cartridge technology.
  • Digital Transformation Trends to Watch in 2019
    Digital Transformation Trends to Watch in 2019
    Seth Earley, CEO, EIS; Andy Hoar, CEO, Paradigm B2B, Minal Parker, Senior Product Mgr, HD Supply Recorded: Nov 7 2018 31 mins
    Join Seth Earley, CEO of Earley Information Science, and special guests Andy Hoar, CEO of Paradigm B2B and Minal Bhargava Parker, Senior Product Manager eBusiness at HD Supply, as they consider the digital trends making the news these days, and identify those that are critical to success in 2019, and those that might just be hype.

    We’ve all heard it – digital transformation is coming for us. From how our customers engage with us, to how our partners leverage us, and how our business operations scale, digital transformation is the ultimate goal for successful eCommerce companies in 2019.

    Yet to be truly strategic and exacting in your digital transformation initiatives, we must first decide which trends are ‘in,’ and which ones are ‘out.’
  • FBI Warning: Cyber Attacks on ATMs - Are you prepared?
    FBI Warning: Cyber Attacks on ATMs - Are you prepared?
    Joan McGowan, Senior Analyst at Celent and Steve Migliore, Head, Cybersecurity at Unisys Recorded: Nov 7 2018 46 mins
    A recent warning issued to banks by the FBI reads like the script for a Hollywood movie: cybercriminals are plotting a sophisticated, global “ATM cash-out” using cloned credit cards to fraudulently withdraw millions of dollars in just a few hours. A few days later, reports of a $13.5 million heist of 25 ATMs across the globe confirmed the reality that ATMs are a prime target for hackers.

    Are you prepared for when an ATM breach occurs, or more importantly, when a hacker gains access to your network and confidential customer information through your ATM networks?

    Join Unisys and Celent for this very critical, time sensitive topic that will help you understand this increasing threat and how to respond.

    In this webinar we will cover:

    •How global trends, such as open banking, will increase these threats
    •How ATM security fits in your end to end security and risk posture
    •We will be discussing Unisys Stealth®, which is a flexible software suite that leverages microsegmentation to secure critical assets
    •And so much more!
  • Protein Sample Prep Tips & Tricks
    Protein Sample Prep Tips & Tricks
    Natasha L. Pirman, Ph.D. Recorded: Nov 7 2018 35 mins
    E. coli is the most widely used recombinant expression system to overexpress protein given that it is inexpensive, easy to scale up, and relatively fast. Due to its wide-spread use, there are numerous molecular tools, products, and expression/purification protocols available. Determining which tools and products to use, such as plasmid, strain-type, affinity tag and resin system, or buffer exchange device can be daunting. Here, we present a workflow overview of the recombinant protein expression from E. coli and provide insight and various tips and tricks about how to optimize and improve protein yield and purity enabling you to make the best decisions for your protein of interest.
  • Training AI-driven Support Bots to Deliver Next Gen CX
    Training AI-driven Support Bots to Deliver Next Gen CX
    Wysdom.AI, Aspect Software, Verizon Recorded: Nov 7 2018 61 mins
    When training an AI-driven virtual assistant, harvesting and reusing knowledge assets is critical to success.

    A good digital experience is about facilitating information flows between the organization and its customers. Whether answering questions on community bulletin boards, self service through FAQ’s, email communications, interactions with call center agents or text exchanges with bots, the objective is to give customers the information they need to use a product, make a selection, solve a problem and achieve their overall goal.

    At the heart of this is knowledge in various formats. In the AI world, it is referred to as “training content” – the knowledge assets that support customers directly or indirectly. Whether training a support engineer or training an AI-driven virtual assistant, harvesting and reusing these assets is key. However in most large organizations training platforms, knowledge bases and support applications have evolved organically with different architectures, changing ownership, fragmented taxonomies and disparate approaches.

    Some believe that AI and machine learning will solve this problem but while these technologies are promising, not every support application and knowledge source is amenable to a fully automated approach. Even when that is possible, certain elements have to be in place.

    In this edition of the Earley Executive Roundtable, our panel of experts tackle such questions as:

    --What does the changing technology landscape mean to support organizations, call centers, and customer service functions?
    --Can knowledge be captured and structured for reuse in a sustainable, economically viable way?
    --How can the customer be supported throughout their journey by knowledge that originates in different parts of the organization?
    --How do processes need to evolve to provide an end to end seamless, positive experience?
  • The Secret to Successful Marketing to the Technical B2B Buyer
    The Secret to Successful Marketing to the Technical B2B Buyer
    EarleyInfoSci, Mouser Electronics, Brock White Recorded: Nov 6 2018 60 mins
    The B2B technical buyer is a unique persona with specialized needs. In order to get and keep this valuable customer on your site you must speak directly to their needs. So, how are the needs of technical buyers defined and translated into an engaging experience? The B2B and B2C ecommerce experiences have many similarities. Some lessons learned from B2C can be valuable to B2B. However, the two markets also have important differences, and the customer journey needs to reflect them.

    In this panel you will learn specifics about:

    --The archetypes of B2B buyer
    --Motivators and demotivators for making purchases
    --How to identify, structure and present content and assets that move the sale forward
    --The critical role of personalization
    --How merchandizing, cross-sell and up-sell leverage organizational knowledge about customer challenges

    This roundtable delivers valuable insights for CMOs, VPs of Digital, and Senior Marketing executives in organizations that operate as manufacturers, suppliers, and/or distributors in the industrial, high-tech, aerospace, life-sciences, and MRO spaces.
  • What's new in PharmaPendium?
    What's new in PharmaPendium?
    Pooja Jain Recorded: Nov 6 2018 64 mins
    Successful drug development requires anticipating safety and regulatory issues as early as possible. PharmaPendium is uniquely positioned to facilitate efficient translational studies of drug safety and efficacy. It supports risk assessment activities with unique access to valuable adverse event and approval documents alongside tools that maximise insights into drug safety and efficacy data.

    The 2018 development plan for PharmaPendium focused on strengthening this position as a support tool for early assessments of drug candidates.

    About this webinar
    Join PharmaPendium Product Manager Pooja Jain to discover the new features that facilitate efficient translational studies of drug safety and efficacy, including:

    - New search and filter capabilities that enable users to specifically search for pharmacokinetic, metabolizing enzyme and transporter data for concomitant drugs and other substances
    - Improvements to PharmaPendium’s unique FDA Adverse Event Reporting System (FAERS) search functionality, including a heatmap and percentage calculator, which make it easier to visualize and compare differences in adverse event reporting
    - Updates to the Drug–Drug Indication Risk Calculator (DDIRC) content to keep pace with user needs for drug–drug interaction (DDI) risk prediction
    - Updates to the MedDRA (Medical Dictionary for Regulatory Activities) taxonomy, which helps ensure that searches conform to the clinically validated international nomenclature used by regulatory authorities
    -Improvements to the Indications taxonomy and search capabilities that provide insight into approved vs tested/off-label indications
    - Email alerts to help users stay up to date on new content relevant for a given search

    The webinar includes demonstrations of all the new features and a Q&A session for attendees to get further information about PharmaPendium’s drug safety and efficacy workflows.
  • Advances and Challenges in Vaccine Development and Manufacture
    Advances and Challenges in Vaccine Development and Manufacture
    Tony D’Amore, Sanofi Pasteur Recorded: Nov 2 2018 41 mins
    This webinar reviews the constraints and complexities of vaccine product development and manufacture.
    The evolution of bioprocess and analytics innovation and technologies to overcome these challenges are discussed.
    The strategy and leveraging of innovation and technology for rapid product development and accelerating timelines is described.
    Case studies to illustrate the advances in vaccine development and manufacture are illustrated.
    A look into the future with state of the art technologies.
  • Introducing Embase French Local Literature Module
    Introducing Embase French Local Literature Module
    Iveta Petrova, Embase Product Manager Recorded: Oct 31 2018 47 mins
    Literature is one of the essential sources to identify high quality ADR reports. Regulatory authorities require companies to monitor major international publications through databases, as well as local, non-English content sources in each of the countries where the drugs are marketed. Currently, the local, non-English content sources is not available in most international literature databases, therefore screening, reviewing and monitoring this type of literature costs extra time, money and creates an additional compliance risk.

    In this webinar, Embase product manager Iveta Petrova will discuss:
    -The challenges in Local Literature Monitoring process for pharmacovigilance, with a focus on the French market
    -The concepts of Embase French Local Literature Module
    -How to use this module in Embase.com to build effective searches to identify the mention of drugs and ADRs in French journals

    About the speaker:
    Iveta Petrova holds a Ph.D. from Leiden University for research done on Wnt signaling in the nervous system. She joined the Embase team at Elsevier as part of the Content quality department. For 2 years she was responsible for writing and updating the indexing guidelines, as well as monitoring the quality of indexing. One year ago she joined the Product management team of Embase. Currently her tasks include continuous engagement with customers and market research to further improve and develop tools to support them in their daily responsibilities, specifically the enhancement of evidence-based medicine, pharmacovigilance and medical device clinical evaluation and safety.
  • Get off Your Lazy NAS by Transforming Your Data Management Strategy
    Get off Your Lazy NAS by Transforming Your Data Management Strategy
    Stefaan Vervaet, Sr. Director, DCS Solutions & Alliances, Western Digital; Krishna Subramanian, COO, Komprise Recorded: Oct 30 2018 25 mins
    NAS is essential to your IT environment, but a lazy NAS can hurt performance, cause you extra work and bust your budget.

    Join experts from Western Digital and Komprise to learn how to transform your data management strategy by gaining visibility and an understanding of your data, automating the movement of inactive data to less expensive storage and optimizing your storage environment.

    In this webinar you’ll learn how to:
    •Increase NAS performance
    •Free up NAS capacity
    •Reduce costs by up to 50% or more
    •Reduce backup times by up to 60 percent or more

    A small investment of time can deliver BIG cost savings!
  • High Precision PCR utilizing ThermaGenix Reagents
    High Precision PCR utilizing ThermaGenix Reagents
    Professor Lawrence Wangh, Founder and CSO of ThermaGenix, Inc. Recorded: Oct 30 2018 47 mins
    The polymerase chain reaction (PCR) is a mainstay of molecular biology and genomics that provides an efficient and rapid in vitro method for enzymatic amplification of DNA or RNA sequences from various sources. There are three unique, easy-to-use PCR additives that act at different temperatures to improve sensitivity and product yield by preventing mis-priming:

    1. ThermaStop™: a novel reagent that acts like a universal hot-start for Type A and Type B DNA polymerases
    2. ThermaGo™: a unique reagent that enhances the specificity of these same enzymes during the course of amplification
    3. ThermaStop™-RT: a first-in-class reagent that acts like a hot-start for many reverse transcriptases.

    Each reagent is a chemically modified oligonucleotide produced under GMP conditions and sold as a dry powder. Stable at room temperature, each reagent can simply be added to the enzyme of your choice prior to adding that enzyme/reagent complex to the master mix. These improvements are observed for both inexpensive Type A Taq polymerases and very expensive HiFi Type B DNA polymerases in applications such as qPCR, multiplexing, and preparation of DNA amplicons prior to next-generation sequencing (NGS).
  • Safety First Throughout the Histology Workflow
    Safety First Throughout the Histology Workflow
    Shalmica Jackson, PhD Recorded: Oct 25 2018 49 mins
    From tissue processing to slide coverslipping, the histology workflow is laden with hazardous steps. Chemical sensitizers, strong acids, alkaline substances, and oxidizing agents are routinely used during histological workflows. These classes of chemicals are known to damage and even destroy living tissues. Ensuring the safety of laboratory workers is of the utmost importance. This workshop will present new approaches to help make the histopathology laboratory a safer environment with the use of formalin-free fixatives, phenol-free stains, DBP-free mounting media, IVD-certified ready-to-use reagents, and more.
  • Emerging Quantum Dot Materials: Synthesis and Application
    Emerging Quantum Dot Materials: Synthesis and Application
    Osman M. Bakr, PhD Recorded: Oct 25 2018 40 mins
    Quantum Dots (QDs) undoubtedly attracted lots of interest with their superior luminescent properties. What is distinct about their luminescent properties is that the wavelengths of emitted light can be precisely tuned by changing of nanoparticle size or composition. Quantum dots possess narrow full width at half maximum (FWHM), high photoluminescence quantum yield (PLQY), emission wavelength tunability through the entire visible and near IR range. In this webinar, we talk about synthesis and application of emerging quantum dots materials: Perovskite and PbS QDs. Perovskite QDs emit light within the visible range, have high PLQY (up to 100 %), narrow FWHM (below 20-25 nm), and are considered as the best alternatives for CdSe and InP QDs for display application. PbS QDs emit light in near IR region with narrow FWHM of absorption and emission, making them ideal in NIR photodetectors and solar cells.
  • The Business Value and Bottom Line Impact of Taxonomy
    The Business Value and Bottom Line Impact of Taxonomy
    Seth Earley, CEO, EIS & Carla Pealer, Taxonomy Consultant, EIS Recorded: Oct 24 2018 53 mins
    Business agility rests upon a well-architected environment of business processes, workflows, and communications.

    So how does taxonomy fit in? It’s everywhere - taxonomy is the foundational building block that improves efficiencies, collaboration, and cost reductions across the enterprise. And the more agile you are, the better opportunity you have to compete and win.

    In this webcat you will learn:

    • Industry-agnostic best practices to boost your bottom line and beat your competition through taxonomy design and semantic integration
    • How taxonomy design enables customer acquisition, search relevancy, structured data, faster time to market, asset reuse, and more.

    Speaker: Carla Pealer, Consultant, Earley Information Science
  • Enhancing key PV Solutions to boost the efficiency of drug safety workflows
    Enhancing key PV Solutions to boost the efficiency of drug safety workflows
    Sherry Winter, Senior Solution Marketing Manager at Elsevier Recorded: Oct 23 2018 51 mins
    Databases of peer-reviewed biomedical literature and regulatory documents are crucial sources for pharmacovigilance activities. When monitored properly, they yield drug safety signals that are essential for risk–benefit assessments and adverse event reports. However, both are vast resources that can be challenging to monitor efficiently and accurately, especially if different interfaces are needed to access each database.

    In 2018, Elsevier is enhancing key solutions for pharmaceutical R&D as part of ongoing efforts to improve the comprehensiveness, efficiency, accuracy and compliance of pharmacovigilance-focused research. By ensuring that all relevant information is captured efficiently, the company is helping drug safety and pharmacovigilance teams deliver considerable improvements in health-critical workflows.

    This webinar focuses on 2018 enhancements to Embase, PharmaPendium and QUOSA PV, showing how each solution offers dedicated means to boost the efficiency and accuracy of the monitoring of relevant databases, assessment of captured information, and supervision of the workflow. These enhancements include:
    - A dedicated Embase query form for efficient creation and validation of the complex search strings needed for high-recall, high-precision literature searching
    - An Embase French Local Language Module to extend the reach of Embase into specially selected French-language literature
    - More capabilities in PharmaPendium for searching the FDA Adverse Event Reporting System (FAERS)
    - Even more flexible means to run and oversee GxP-compliant workflows through QUOSA PV, with new functionalities for medical review, signal management and quality assurance. The webinar will address these solutions and enhancements in the context of comprehensive support for the goals of pharmacovigilance.
  • Making new connections – An overview of new TLC-MS Applications Session 2
    Making new connections – An overview of new TLC-MS Applications Session 2
    Michaela Oberle Recorded: Oct 23 2018 48 mins
    In the last decade the trend for hyphenating different analytical techniques became an more and more important role in analytical labs. Combinations like LC-LC-MS or LC-MS-MS help to solve the analysis of complex samples in a proper way. The Analytical data which could be received are more sensitive focused on special analytes or give a better overview of the whole sample composition.

    This webinar should give the attendances an overview of the advantage and strength of (HP)TLC- MS coupling technique along various Applications from different analytical fields using different MS techniques. Tips and tricks for the right handling are be presented, to avoid main basic defaults.
  • Making new connections – An overview of new TLC-MS Applications Session 1
    Making new connections – An overview of new TLC-MS Applications Session 1
    Michaela Oberle Recorded: Oct 23 2018 51 mins
    In the last decade the trend for hyphenating different analytical techniques became an more and more important role in analytical labs. Combinations like LC-LC-MS or LC-MS-MS help to solve the analysis of complex samples in a proper way. The Analytical data which could be received are more sensitive focused on special analytes or give a better overview of the whole sample composition.

    This webinar should give the attendances an overview of the advantage and strength of (HP)TLC- MS coupling technique along various Applications from different analytical fields using different MS techniques. Tips and tricks for the right handling are be presented, to avoid main basic defaults.
  • 3D Organ-on-a-chip Applications Using the AIM Biotech Chip
    3D Organ-on-a-chip Applications Using the AIM Biotech Chip
    Kuan Chee Mun and Mahama Aziz Traore Recorded: Oct 22 2018 31 mins
    In vitro 3D cell culture models have emerged as a bridge between conventional 2D cell culture models and the complex & expensive in vivo animal models. By analyzing and comparing the biological behavior of tissues embedded in 3 dimensional hydrogels, results are significantly different from classic 2D cell culture in terms of proliferation, morphology, drug response and gene expression. These differences have been attributed to the topographically complex 3D environment surrounding the cells, where cell adhesion, structure, effector transport and mechanotransduction are substantially altered. A carefully designed 3D model can provide more physiologically relevant information using experimental designs unachievable by conventional 2D assays at a fraction of the cost of in vivo models.
    Current 3D cell culture assays like hanging drop culture often lack the capability to organize different co-cultured cell types in a meaningful way. The application of chemical gradients or flow is usually not possible.
    We are now able to address this issue with a modular microfluidic platform that can co-culture multiple cell types in discrete 3D and 2D channels. Organotypic assays with animal model-like complexities using human cells have been developed for research, drug discovery & diagnostics. These include models for immune checkpoint, T-cell killing efficiency, angiogenesis, metastasis, cell migration, microvascular networks and the blood-brain barrier. Additional applications that focus on a liver model will also be discussed. Drug Induced Liver Injuries (DILI) contributes to drug failures, drug withdrawals and acute liver failures. The liver strongly interacts with other organ systems and in some instances the metabolites secreted by the liver are responsible for other organs' injury. Engineered 3D liver models may increase the physiological relevance of drug toxicity by maintaining the expression levels of key cytochrome P450 enzymes and metabolic activity in liver cells.
  • Evolve Manufacturing Processes by Implementing Disruptive Technologies
    Evolve Manufacturing Processes by Implementing Disruptive Technologies
    Yuyi Shen, Associate Director at Bolt Bio, John Cyganowski, Director of Manufacturing Sciences for MilliporeSigma Nov 19 2018 5:00 pm UTC 75 mins
    The desire for innovative technology that can eventually cause disruptive changes remains high in the biotech pharmaceutical industry. The road between pursuing and developing that technology to genuine implementing is not a smooth ride. In this webinar, the presenter identifies key challenges of implementing innovative technologies and the major drive for implementing innovative technologies and process upgrades. The presenter will share some case studies of implementing successful innovation tools and provide comparative economic analysis based on the understanding the true value of innovation driven process design. The webinar also provide the insight of the balance needs for quality, cost and speed.
  • 多段型セルカルチャーおよびマイクロキャリアによる細胞培養技術セミナー
    多段型セルカルチャーおよびマイクロキャリアによる細胞培養技術セミナー
    コーニングインターナショナル株式会社  ライサイエンス事業部 石渡 孝至 Nov 21 2018 6:00 am UTC 60 mins
    バイオロジクスの治験薬製造における効果的な細胞培養と分離工程の簡素化を実現させる幹細胞・癌細胞の基礎的培養技術を概説いたします。
    今回は、大量培養に向けたシングルユース技術導入のポイントを概説します。

    <セミナーのポイント>
    実際に静置型/撹拌型のシングルユース培養容器を使用した時のヒト間葉系幹細胞(hMSC)及びヒト胎児腎細胞(HEK293T)の培養データを例示します。
  • How to drive digital agility & efficiency in the Pharma & Life Sciences industry
    How to drive digital agility & efficiency in the Pharma & Life Sciences industry
    Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe) Nov 21 2018 3:00 pm UTC 60 mins
    The 2018 Digital Trends report released by Adobe & Econsultancy found that only 5% of healthcare and pharma organizations reported being digital-first. Yet in today’s digital world, there has never been a better time for the Pharma industry to innovate and improve health outcomes whilst driving business performance. Technology has sparked a revolution across all functions, from research and development to sales and operations. However, meeting these demands is not without its challenges. The unique nature of the pharma and life sciences industry means that it faces issues that other businesses do not have to grapple with. There are complex supplier networks, growing regulatory requirements and increasing pressure to reduce costs – so what can digital leaders do to effect change quickly?

    Join Econsultancy & Adobe in this webinar to learn:
    • The reality of the digital first challenge and the trends causing complexity.
    • How technology is shaping the future and the opportunities for digital agility & efficiency.
    • How Merck transformed time consuming business processes though digital workflows – accelerating business, and improving the employee & customer experience.
    • How electronic signatures can digitally transform your documents and workflows, accelerating an organisations digital transformation journey.
    • How to ensure you stay compliant with regulations including a live demonstration the BioPharma module (covering Title 21 CFR Part 11)
  • How to accelerate FTO searches on sequences by 70%
    How to accelerate FTO searches on sequences by 70%
    Jessie Parker @ PatSnap Nov 21 2018 4:00 pm UTC 60 mins
    Scientists in the biotech and pharma industries spend a large amount of time and resources on researching sequences. However, often as researches progress to the later stages of R&D, they become blocked by competitors and products that are already on the market.

    Using a sequence searching tool which links to patent data can help you identify obstacles and freedom to operate much earlier on. Having access to a full data set sooner, can help you save time, money and enhance your R&D.

    Join this webinar to find out how you can accelerate FTO searches on your sequences.
  • Can simulated datasets unlock the potential of patient data?
    Can simulated datasets unlock the potential of patient data?
    Jem Rashbass, Health Data Insight, Chris Carrigan, use MY data, Adam Reich, IQVIA, Dominic Tyer, pharmaphorum Nov 27 2018 2:00 pm UTC 75 mins
    Patient level data offers the promise of insights which can craft new and better pathways, enable development of innovative therapies and treatments, and of course identify and prevent diseases much earlier in their lifecycle.

    One area of particular interest is cancer. However, in trying to realise the potential, the health sector is faced with the conundrum of protecting patients’ identities, while at the same time allowing doctors access to their data and enabling industry to benefit from vital insights into the disease.

    This presents a paradox, as the UK has some of the best healthcare data in the world, however, accessing the data can be challenging and time consuming due to patient confidentiality checks.

    So, what is the solution?

    IQVIA brings a unique perspective to this event, having partnered with Health Data Insight to develop an innovative solution to this seemingly intractable problem: Simulacrum, a database comprised of only artificial data that is modelled on real patient data collected by the National Cancer Registration and Analysis Service (NCRAS) in England.

    Simulacrum has already produced identical results to the real data when predicting incidence of tumours in the population, whilst simultaneously removing any risk of breaching patient confidentiality.

    In this webinar, IQVIA and pharmaphorum will also provide advice to industry, patient advocacy groups and healthcare professionals on how to leverage Simulacrum, and utilise this simulated dataset to facilitate access to England’s world-leading healthcare data, while complying with regulations designed to protect and maintain individual confidentiality.
  • Why Security Matters: Global Insights to the 2018 Unisys Security Index Survey
    Why Security Matters: Global Insights to the 2018 Unisys Security Index Survey
    Tom Patterson, Chief Trust Officer, Unisys Nov 28 2018 3:00 pm UTC 60 mins
    Despite spending billions of dollars every year on security, companies and governments – as well as the products and services they use – often lose sight of their ultimate goal: protecting the user. Please join this webinar to hear Tom Patterson, the Chief Trust Officer for Unisys, share results and realities from the only recurring snapshot of consumer security concerns conducted globally. This year’s global Unisys Security Index survey brings to light key areas of consumer concern that are vital to understand, if society and the security sector are to be successful in achieving their goals.

    Major findings affecting government services, entire business sectors and fast evolving technologies are all illuminated through the lens of the user, as opposed to the more typical providers. Learn what’s most important to the consumer in each region of the world, and across key demographic categories. This clarity of vision, brought by thousands of statistically significant consumers from around the world, is a voice that needs to be heard.

    Tom will use this year’s results, juxtaposed with over a decade of survey history and informed by global events and leaders from both government and industry, to provide a cogent report on the state of global security from the perspective that matters most—the user.
  • Machine Learning, Personalized Medicine, and the Future of Drug Discovery
    Machine Learning, Personalized Medicine, and the Future of Drug Discovery
    Gabe Musso, CSO, BioSymetrics Nov 28 2018 4:00 pm UTC 75 mins
    Despite tremendous achievements in the fields of Artificial Intelligence (AI) and Machine Learning (ML), there remain several areas in healthcare and drug discovery where AI/ML has seen limited success. This includes, notably, improving the high attrition rates associated with discovery of new drugs. As genomic data becomes more widely available and clinical data continue to become digitized, there is an opportunity to use this data to understand and predict drug activity at a more personalized level than ever before. So what limits the application of AI/ML in the precision medicine & drug discovery space? Here we discuss the practical advantages and limitations of AI/ML as it relates to precision medicine and drug discovery, focusing on challenges that need to be addressed before the promise of AI-based approaches can be realized.
  • Literature searching in Health Economics
    Literature searching in Health Economics
    Julie Glanville, Associate Director at York Health Economics Consortium Dec 3 2018 3:00 pm UTC 75 mins
    Please note: change of date!

    In this webinar, Julie Glanville , Associate Director at York Health Economics Consortium, will discuss literature searching in Health Economics.

    Health economics evidence is a key element in much health services research and particularly in health technology assessments. Health economic models are increasingly used to assist with health care decision making. Identifying economic evidence to inform such research can involve searches in a range of databases and using a variety of strategies.

    This webinar will summarize the key resources which can be searched to identify health economics information including economic evaluations and economic models. We will also explore how to design search strategies to find economic evaluations including economic models. With the closure of key economic evaluation databases (NHS EED and HEED) we will be focusing on how to identify economic evaluations from major bibliographic databases.

    Julie Glanville is Associate Director at York Health Economics Consortium, part of the University of York. Here, she manages systematic review and literature review projects. She also organizes the YHEC training programme.

    YHEC provides a range of research services including literature searches and evidence identification to inform research projects in healthcare topics but also in other fields such as food safety and feed safety, social care, housing, criminal justice and education. YHEC contributes to the evidence base for information retrieval with a special focus on identifying economic evidence and search filters (strategies) for a range of research methods.

    YHEC carries out systematic and non-systematic reviews for a range of clients to identify the effects of drugs, devices and other interventions. The training program also partners with Quantics Consulting to provide indirect treatment comparisons (ITCs) and mixed treatment comparisons (MTCs).
  • New Preparation Approach for Improved Pesticide Analysis of Challenging Samples
    New Preparation Approach for Improved Pesticide Analysis of Challenging Samples
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, Germany Dec 4 2018 6:00 am UTC 75 mins
    For Pesticide Analysis in food and feed QuEChERS is an established Sample Preparation technique. Nonetheless there are some challenging sample matrices that require variations of the classical QuEChERS methodology. These are fat-rich matrices, intensively coloured matrices and dry, complex matrices such as teas, spices or herbs.

    As even the variations in the official methods AOAC 2007.01 and EN 15662:2008 cannot fully remove all matrix interferences, this talk will introduce new sample preparation approaches leading to improved clean-up and recovery of pesticides in these challenging matrices.
  • Next Generation IHC
    Next Generation IHC
    Jeff Gordon Dec 5 2018 4:00 pm UTC 75 mins
    Immunohistochemistry has now been a staple in diagnostic pathology for decades. This is partially due to pathologist utilization of antibodies in the realm of specialty panels. As the science evolves, the panels evolve, creating demand for the next generation of antibodies to improve diagnostic capabilities. This talk will give an overview of some of these novel diagnostic markers and how they fit into the specialty panels with the traditional antibodies to provide the best diagnostic capabilities to the pathologist, therefore giving the patient the best care available.
  • The devil’s in the e-detail: what HCPs really want from you
    The devil’s in the e-detail: what HCPs really want from you
    Heiko Schmidt, Integrated Multichannel Marketing and Sales, Bayer, Sari Ruth Carter, Head of Marketing, Anthill Agency Dec 6 2018 10:00 am UTC 75 mins
    Overview:
    Communication; we all do it, it is a critical part of effective business practice and in this pharma is no exception.

    It is no secret that for pharma companies, face time with healthcare professionals (HCPs) has reduced drastically over the last 10 years while the cost of in person engagements has increased significantly.

    Like any customer their expectations for the content they receive have changed, with a focus on useful, succinct and easy to consume materials rather than the sales materials of old.

    So what is it that HCPs want and through this lens, what is it that pharma should be doing?

    The evidence points towards creating meaningful two-way conversations through multiple channels, connecting otherwise siloed touchpoints with and for HCPs in the process.

    For the past 40 years detailing has been the backbone of pharma/HCP communication – but what about e-Detailing? Is it just detailing on an ipad or is it supposed to be something more? How does this fit and what is possible, and more importantly desirable?

    To analyse the current situation and present practical insights, pharmaphorum presents a new free to attend digital debate. Working with our partner Anthill agency we have put together a panel of leading experts from Bayer and Anthill.

    This debate will cover:

    •What is the current landscape for optimal HCP communication?
    •What is the future in terms of HCP channel preference?
    •New technologies in pharma marketing that help you to better engage with HCPs and extend HCP reach – AI, chatbots, self-detailing
    •How to reach more HCPs, when, where and how they want
    •How to overcome low content usage by HCPs
    •The most common challenges for traditional eDetailing effectiveness
    •How to achieve better communication without having to reinvent the wheel
    •How to activate your existing content and reach all customers willing to engage with your brand, regardless of their preference.
  • Metrics to meaning: demonstrating the value of medical communications
    Metrics to meaning: demonstrating the value of medical communications
    Lynda Chang, Scientific Director, Complete HealthVizion, David Pearce, Commercial Director, Complete HealthVizion Dec 6 2018 3:00 pm UTC 75 mins
    Medical affairs and publications teams are under increasing pressure to demonstrate effectively the success of the medical communications activities they undertake.

    Naturally, there are a huge number of metrics that could be used to measure and demonstrate medical communications value. The challenge is to identify, and track, those metrics that really matter, and ensure this information is interpreted effectively.

    This pharmaphorum webinar, which will be held in partnership with Complete HealthVizion, will look at how to measure medical communications activities, how to continue with what is successful and how to change what isn’t working.

    This means identifying what can be measured, both in terms of reach and engagement as well as behavioural impact, deciding what ‘great’ looks like and how best to define success.

    The expert panel will also look at how behavioural science can provide a framework to develop smarter communications and, ultimately, drive better patient outcomes.

    This Metrics to Meaning webinar will take place on Thursday, 6 December, at 15:00 pm GMT (10:00 EST) and will teach you how to measure the effectiveness of different types of medical communications programmes.

    Interacting with the panel will also allow you to learn about a range of practical approaches to implementing metrics, including:

    • Innovative ways to measure medical communications value and success
    • How to help medical affairs and publications teams demonstrate greater value
    • How to optimise tactical outputs year on year
    • The importance of demonstrating and measuring behavioural change

    In doing so they will also discuss the role of behaviour and the implications of this for measuring success.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials
    Ingrid Hayenga, PhD & Markus Obkircher, PhD Dec 12 2018 7:00 am UTC 75 mins
    his webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials
    Ingrid Hayenga, PhD & Markus Obkircher, PhD Dec 12 2018 3:00 pm UTC 75 mins
    This webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • 3Dスフェロイド培養のアプリケーションとミニチュアライズ
    3Dスフェロイド培養のアプリケーションとミニチュアライズ
    コーニングインターナショナル株式会社 ライフサイエンス事業部 江藤 哉子 Dec 20 2018 6:00 am UTC 60 mins
    弊社独自の超低接着表面・形状のプレートを用いた三次元がんスフェロイドや免疫細胞の作用モデルなどのハイスループットスクリーニングやオルガノイド作製の実例を交えて概説いたします。
    今回は、3Dスフェロイを使用したアプリケーションをご検討中のみなさまに向けて基礎から実際のアプリケーションまでをお話しいたします。
  • Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry
    Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry
    Don Singer, GlaxoSmithKline R&D Jan 9 2019 3:15 pm UTC 75 mins
    The pharmaceutical industry paradigm change is occurring and industry has taken an important leap towards formality of quality improvement using quality tools. Recent industry and regulatory support of ‘risk-based’ concepts and principles are leading to a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety and efficacy.
    Microbiologists’ role as active partners in the pharmaceutical environment is to help transform industry to a routine Quality by Design paradigm. With the help of quality tools and using the concepts and principles of Quality by Design, a better understanding of how and where to implement microbiological control of processes can be developed, and microbiological purity can be built into products for all patient populations.
  • Challenges Faced by the End Users During the Qualification of Single Use System
    Challenges Faced by the End Users During the Qualification of Single Use System
    Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead, Sanofi, Swiftwater Jan 14 2019 2:45 pm UTC 75 mins
    Pharmaceutical industry has been increasingly using single use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry that the end use faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.
  • mAb Industry in China: Biosimilars vs. Innovative Biologics
    mAb Industry in China: Biosimilars vs. Innovative Biologics
    Dr. Joe X Zhou is the CEO Walvax Bio Group & Floris D Smet, Director of Field Marketing, Sarotrius China Jan 15 2019 8:00 am UTC 75 mins
    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
  • Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
    Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
    Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT Jan 25 2019 10:00 am UTC 75 mins
    Downstream processing of Biosimilar Monoclonal Antibody utilises variety of raw materials that a critical for achieving the desired product quality. In this webinar, we would like to discuss the data from three cases of lot to lot variability namely Depth filtration, Chromatographic resin and buffer component used in downstream chromatography unit operations. Changes in lots of depth filter resulted in significant clogging and differences in Host cell impurity clearance. Similarly, changes in resin lots resulted in increased back pressure during processing and variability in buffer raw material lots resulted in undesirable colouring of resin upon contact. In each case, we will present the root cause investigation, impact on product quality profile and associated CAPAs to control the effects of variability to ensure manufacturing continuity.
  • Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Ex
    Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Ex
    Dr Xin Bu, Principal Scientist, Bristol-Myers Squibb Feb 5 2019 3:00 pm UTC 75 mins
    Dissolution is one of the critical quality attributes for solid oral dosage forms, typically tablets and capsules. In addition as a quality control (QC) test to release commercial products, dissolution is often used as a comparative test to 1) apply biowaiver for lower strength(s) when multiple strengths of one product with the same or similar formulation are marketed, or 2) support post approval changes. In these cases, in-vitro dissolution test is used in place of in-vivo bioequivalence study to establish equivalency between products of different strengths or pre- and post-change. Guidances provided by major regulatory agencies, the United States Food & Drug Administration (US FDA) and European Medicines Evaluation Agency (EU EMEA) are often followed by many countries around the world. However some countries/ regions, such as Australia, Japan, China, Taiwan and Korea have their own country specific guidances. The dissolution requirements by the FDA and EMEA are generally similar, and depend on the type and level of changes as outlined in the relevant guidances. The requirements from other mentioned countries are often significantly different from that of US and EU, and different from each other. For products marketed globally, it’s prudent to understand the differences amongst the different country requirements when applying post approval changes using dissolution to demonstrate equivalency. Several sets of comparative dissolution studies may have to be conducted in order to satisfy all regulatory agencies. This presentation compares differences in dissolution testing requirements among the listed countries and provide examples to illustrate how for conduct studies to comply with the relevant guidance(s).
  • Extractables and Leachables have been used interchangeablely for too long. Are w
    Extractables and Leachables have been used interchangeablely for too long. Are w
    Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma Feb 6 2019 3:00 pm UTC 75 mins
    Title: Extractables and Leachables have been used interchangeablely for too long. Are we still confused?
    Presenters: Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma

    Description:TBA
  • Host Cell Protein Characterisation and Mass Spectrometry Strategies
    Host Cell Protein Characterisation and Mass Spectrometry Strategies
    Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist, Bioprocessing Technology Institute, A*STAR  Feb 19 2019 8:00 am UTC 75 mins
    Adding Mass Spectrometry as part of the host cell protein workflow
    Analytical Strategies in HCP identification and purification process
    Developing Quantitative MS/MS method to determine HCP Levels
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Sune Klint Andersen, Janssen Pharmaceutica & Filipe Gaspar, Hovione FarmaCiência Feb 19 2019 3:00 pm UTC 75 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry
    PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry
    Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Ro Feb 21 2019 9:00 am UTC 75 mins
    Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.
  • Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Ru Zang, Senior Process Engineer at Momenta Pharmaceuticals and John Bonham Carter, Director of Upstream Sales at Repligen Feb 25 2019 4:00 pm UTC 75 mins
    EFFECT OF CELL CULTURE PROCESS CHANGE FROM FED-BATCH TO CONTINUOUS ON PRODUCTIVITY AND PRODUCT QUALITY

    Integrated continuous bioprocessing has attracted a growing interest due to its potential to improve agility and flexibility in the manufacture of therapeutic proteins. To convert an existing fed-batch cell culture process to continuous, or perfusion, the major technical hurdles include maintaining steady state cell culture performance and generating product with comparable product quality attributes. In this presentation, we evaluated three molecules including a fusion protein, an aglycosylated monoclonal antibody (mAb), and a glycosylated mAb. Steady state culture at high cell density was achieved for all three molecules, which allows the delivery of products with consistent product quality and adequate productivity. However, as compared to fed-batch processes, product quality and cell specific productivity differences were observed in perfusion cultures. Further studies indicated that it was feasible to modulate product quality in perfusion process by adding process levers in culture medium. It was also feasible to increase cell specific productivity through medium and process optimization. This presentation provides an insight into the product quality and productivity differences between traditional fed-batch and perfusion cell culture processes and potential approaches to addressing these differences.