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Life Sciences

  • Generation of a landing-pad T cell line useful for T cell receptor customization
    Generation of a landing-pad T cell line useful for T cell receptor customization Stacey Ward, PhD Recorded: Apr 18 2018 49 mins
    T cell biology is integral to the study of normal immune regulation as well as cancer biology, Car-T cells, epitope specificity and antigen presentation. However, primary T cells can be difficult to propagate in culture for the length of time necessary for functional assays. In addition, primary T cells express variant T cell receptor (TCR) heterodimers that can be challenging to identify and may not be optimal for downstream studies. We sought to simplify this system using transformed T cells which can be grown in culture for extended periods of time. We engineered a floxed landing pad sequence into the safe harbor AAVS1 genetic locus using CompoZr zinc finger nucleases. Both the promoter and landing pad expression cassette are flanked by unique lox sites, allowing swapping of either the promoter and/or expression cassette as needed. We ensured that only one copy of this sequence was found within the genome to avoid any complications associated with random insertion events. We also generated a landing pad cell line null for the endogenous TCR using Cas9/CRISPR ribonucleotide complexes. Both the TCR alpha and beta loci were rendered null due to non-homologous end joining and the presence of insertions and deletions culminating in premature stop codons were genotyped using next generation sequencing. The absence of a functional TCR was validated using flow cytometry staining for surface TCR and CD3. This cell line was then used to generate a knock-in of the desired exogenous TCR heterodimer to the landing pad locus, verified using flow cytometry staining. These lines will be very useful for a multitude of studies where a researcher needs to express a gene of interest in a discrete genetic locus or wants to generate a panel of TCR expressing cell lines.
  • Generation of a landing-pad T cell line useful for T cell receptor customization
    Generation of a landing-pad T cell line useful for T cell receptor customization Stacey Ward, PhD Recorded: Apr 17 2018 45 mins
    T cell biology is integral to the study of normal immune regulation as well as cancer biology, Car-T cells, epitope specificity and antigen presentation. However, primary T cells can be difficult to propagate in culture for the length of time necessary for functional assays. In addition, primary T cells express variant T cell receptor (TCR) heterodimers that can be challenging to identify and may not be optimal for downstream studies. We sought to simplify this system using transformed T cells which can be grown in culture for extended periods of time. We engineered a floxed landing pad sequence into the safe harbor AAVS1 genetic locus using CompoZr zinc finger nucleases. Both the promoter and landing pad expression cassette are flanked by unique lox sites, allowing swapping of either the promoter and/or expression cassette as needed. We ensured that only one copy of this sequence was found within the genome to avoid any complications associated with random insertion events. We also generated a landing pad cell line null for the endogenous TCR using Cas9/CRISPR ribonucleotide complexes. Both the TCR alpha and beta loci were rendered null due to non-homologous end joining and the presence of insertions and deletions culminating in premature stop codons were genotyped using next generation sequencing. The absence of a functional TCR was validated using flow cytometry staining for surface TCR and CD3. This cell line was then used to generate a knock-in of the desired exogenous TCR heterodimer to the landing pad locus, verified using flow cytometry staining. These lines will be very useful for a multitude of studies where a researcher needs to express a gene of interest in a discrete genetic locus or wants to generate a panel of TCR expressing cell lines.
  • In Vitro Transporter Models for ADME-Tox Research
    In Vitro Transporter Models for ADME-Tox Research Joseph Zolnerciks, Ph.D. Recorded: Apr 10 2018 62 mins
    Drug transporters play a pivotal role in mediating the disposition of many drugs. As a result, researchers in the fields of drug discovery and development have shown a steadily rising level of interest in transporter-drug interactions, transporter-mediated drug-drug interactions, and the role of transporters in determining drug toxicity. For the past 18 years, SOLVO Biotechnology has pioneered the development and commercialization of in vitro assay systems to enable the study of drug transporters. One such system commonly employed for this purpose are inside-out membrane vesicles. Generated from cells over-expressing a transporter of interest, these membranes can be used to examine members of the ATP-Binding Cassette (ABC) transporter family, which includes P-glycoprotein (P-gp; MDR1), bile salt export pump (BSEP), breast cancer resistance protein (BCRP), and the multidrug resistance-associated proteins (MRPs). A versatile assay system, transporter-drug interactions can be monitored indirectly using ATPase measurements, or by directly measuring substrate transport using fluorescent or radiolabeled compounds, or by LC-MS detection. The advantages and limitations of this assay system will be discussed, and we will detail how inhibition of transporters involved in bile acid homeostasis is being used for predictive drug-induced liver injury (DILI) studies. In addition, we will examine the role that the lipid composition within the membrane plays on transporter activity within the context of the latest range of SOLVO mammalian membrane vesicles products for transporter research.
  • Getting Started with SAS Certification
    Getting Started with SAS Certification Becky Gray (SAS), Terry Barham (SAS), Matt Scicchitano (SAS), Mark Stevens (SAS) Recorded: Apr 10 2018 52 mins
    SAS Global Certification experts present an introduction to SAS certification topics to help you reach your SAS Certification goals. After watching, learn more at: sas.com/certify
  • The Laboratory’s Role in the National Healthcare Safety Network
    The Laboratory’s Role in the National Healthcare Safety Network Robert L. Sautter, Ph.D., HCLD (ABB), CC Recorded: Apr 9 2018 59 mins
    In this webinar, Dr. Sautter will discuss the important collaboration efforts between the government and healthcare facilities to stop prevalent and dangerous hospital-acquired infections. After the webinar, you will be able to:

    • Explain how the laboratory and the NHSN can work together to lower infection rates in hospitals
    • Learn how to lower rates of infections, such as blood culture contamination, MRSA and C. difficile
    • Identify how pre-analytic culture collection can affect the results of clean catch and catheter-related infections
    • Discuss how laboratories can work together with the NHSN, an infection surveillance program created by the CDC to eliminate HAIs, to identify problem areas and measure the progress of prevention initiatives

    P.A.C.E. credit is available for your participation.*

    Dr. Sautter is a teacher, lecturer and industry consultant. He earned his B.S. and M.S. degrees from Eastern Michigan University in the areas of biology and molecular biology, respectively, and his Ph.D., from Wayne State University, in Detroit, Mich., in microbiology. During his career, he held positions as a medical technologist, director of microbiology and medical director for a number of laboratories, before becoming an esteemed consultant for a variety of industry leaders in the area of microbiology.

    *Beckman Coulter Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. These credits are recognized by the State of California. Most programs also provide State of Florida credits (with valid license number). At this time, we cannot issue continuing education credits for those who provide healthcare (or work for an institution that provides healthcare) in Massachusetts or Vermont.
  • Filtration in Dissolution Testing: Improving Throughput and Reducing Variability
    Filtration in Dissolution Testing: Improving Throughput and Reducing Variability Vivek Joshi, Ph.D. Recorded: Apr 2 2018 53 mins
    In vitro dissolution testing is used to characterize drug compounds throughout their development. In early drug development it is used to support the choice of a particular formulation. During drug production it is a critical component of the quality control process and is used to assess the changes in manufacturing processes or formulation. In order for dissolution results to be meaningful at each stage, the test and the process need to be reliable, consistent, predictive and accurate.

    Filtration as the only sample preparation step plays an important role in the dissolution process, yet this step is often taken for granted. The choice of frits or syringe filters is often based on experience with previous formulations or availability in the lab. Selecting the wrong filter can result in inadequate filtration, low analyte recovery, solvent incompatibility or extractables that reduce accuracy and reproducibility. The wrong pore size or device can result in clogging that can adversely affect throughput and sample processing.

    This seminar describes different membrane characteristics and provides guidance in selecting the right filtration devices for sample preparation following in vitro dissolution. Problems that result from using the wrong filter are presented along with steps one can take to solve each problem. Filter characteristics that affect drug recovery and downstream analysis, such as non-specific binding and extractable levels, are presented. Steps one can take to optimize throughput and reduce downtime are addressed including a discussion on membrane properties and guidance on the use of multi-layer and automation compatible filters. Recommendations are presented for choosing the right sample preparation device that will help improve throughput, reduce sample processing time and enhance test accuracy and reproducibility.
  • Basics of Immunohistochemistry
    Basics of Immunohistochemistry Jeff Gordon, OEM Sales, Merck KGaA, Darmstadt, Germany Recorded: Mar 30 2018 72 mins
    Immunohistochemistry is the technology of detecting cellular and infectious agent proteins in tissue with antibodies and then labeling those antibodies with a chromogen so that they are detectable under a light microscope. This science has become a standard method in diagnostics for classifying neoplasms and detecting infectious microbes. The science and technique behind immunohistochemistry are discussed in this webinar.
  • Accelerating Research Innovation with Next-Gen Storage Infrastructure
    Accelerating Research Innovation with Next-Gen Storage Infrastructure Vas Vasiliadis, Chief Customer Officer, Globus Recorded: Mar 22 2018 41 mins
    For research data to be truly useful, it must be easy to access, share and manage without requiring expensive, custom infrastructure. What organizations need is turnkey storage that won't break the bank, with a unified interface for fast, reliable data transfer and sharing.

    This webinar introduces Globus for ActiveScale, a cost-effective solution for on-premise object storage that’s simple to deploy and use. With Globus for ActiveScale, researchers have access to advanced capabilities for managing data across a broad range of systems, while administrators gain a cost-effective, scalable, and durable solution they can deploy quickly to help their researchers innovate faster.

    In this webinar, attendees will:
    - Learn how to deploy and use Globus for ActiveScale
    - See a product demonstration
    - Engage in a live Q&A session with the Globus Chief Customer Officer
  • CRISPR: Updates and trends in opposition and appeal practice before the EPO
    CRISPR: Updates and trends in opposition and appeal practice before the EPO Catherine Coombes (HGF), Dr. Chris Moore (HGF), Peter Scott (WIPR) Recorded: Mar 21 2018 42 mins
    This webinar will be on opposition and appeals practice before the EPO. We’ll be discussing the streamlining of the opposition procedure by the EPO, the changes that we are seeing as a result and will be providing practical tips in view of these changes. The talk will also draw on recent case law.
  • UK pharma and integrated health
    UK pharma and integrated health Stephen Dorrell, NHS Confederation, James Roach, Accountable Care Partnership, Essex Andrew Smith, Cobic, Steve Jowett, IQVIA Recorded: Mar 21 2018 64 mins
    The concept of integrated healthcare is not new to the UK, where it has been discussed since the late 1960s.

    The difference is that now it could really happen. Technology, medicine, regulation and pricing have all evolved to a point where a collaborative, integrated system is not only possible, but desirable – and the data needed for it to become a reality is now available.

    What does this mean for UK pharmaceutical companies that have historically focused on providing medicines and treatments?

    On one hand there are calls for them to change – going beyond being simply a supplier of products and moving into the role of partner, sharing risk to drive great health outcomes.

    On the other hand, the industry’s move into having pipelines that are largely stocked with niche products has created pricing and access questions which are yet to be fully answered.

    Analysing the current situation and looking for potential routes to the future, this high-level IQVIA/pharmaphorum webinar gave an update on the latest developments and debated how pharma can be a catalyst for change at a time when the NHS is under immense pressure to cut costs and become more efficient.

    Insight on these pressing issues was provided by a panel of influential healthcare experts that included former secretary of state for health, and NHS Confederation current chairman, Stephen Dorrell.

    He was joined by:
    James Roach, director, Accountable Care Partnership, West Essex Health and Care System
    Andrew Smith, director, Cobic
    Steve Jowett, country lead for health system engagement, IQVIA

    Watch the digital debate to learn more about:

    The evolving NHS and the STP/ICS model of delivery
    What a collaborative future could look like
    The role of data in the future NHS
    Why the STP/ICS model is important for pharma
  • SUS Leachable Testing: Leachable Study Design for Single-Use Components
    SUS Leachable Testing: Leachable Study Design for Single-Use Components Kathryn McGohan Recorded: Mar 20 2018 69 mins
    The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
  • Nano- and Microfabricated Hydrogels for Regenerative Engineering
    Nano- and Microfabricated Hydrogels for Regenerative Engineering Ali Khademhosseini, PhD Recorded: Mar 15 2018 66 mins
    Engineered materials that integrate advances in polymer chemistry, nanotechnology, and biological sciences have the potential to create powerful medical therapies. Our group aims to engineer tissue regenerative therapies using water-containing polymer networks, called hydrogels, that can regulate cell behavior. Specifically, we have developed photocrosslinkable hybrid hydrogels that combine natural biomolecules with nanoparticles to regulate the chemical, biological, mechanical and electrical properties of gels. These functional scaffolds induce the differentiation of stem cells to desired cell types and direct the formation of vascularized heart or bone tissues. Since tissue function is highly dependent on architecture, we have also used microfabrication methods, such as microfluidics, photolithography, bioprinting, and molding, to regulate the architecture of these materials. We have employed these strategies to generate miniaturized tissues. To create tissue complexity, we have also developed directed assembly techniques to compile small tissue modules into larger constructs. It is anticipated that such approaches will lead to the development of next-generation regenerative therapeutics and biomedical devices.
  • Process analytical Technology for Upstream Bioprocessing
    Process analytical Technology for Upstream Bioprocessing Erica Fratz-Berilla & LCDR Agarabi Recorded: Mar 5 2018 71 mins
    In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.
  • Making patent searches more effective with Boolean
    Making patent searches more effective with Boolean Dvorah Graeser from KISSPatents and Ruta Sudmantaite @ PatSnap Recorded: Feb 28 2018 49 mins
    Patent searching is something most IP counsel is very familiar with. It's your day to day when looking at Freedom to Operate, competitive analysis and portfolio management.

    However, it can be hard to predict what you need in a search when you are not a technical expert. In this webinar, we will teach you how to construct the most effective searches using boolean and a few other tips and tricks on how to ensure you include all the technical detail you need.
  • HGST SVR2U24 NVMe Storage Server
    HGST SVR2U24 NVMe Storage Server Manfred Berger, HGST - Sr. Mgr. Business Development Platforms EMEAI Recorded: Feb 27 2018 33 mins
    In this webinar Manfred Berger introduces the latest addition to the HGST platform portfolio, the SVR2U24 NVMe all-flash storage server.

    Combining high performance NVMe SSDs and Intel®’s Purley server architecture into one tried and tested unit, the SVR2U24 enables customers to come to market quickly with a multitude of software defined storage solutions or data base servers optimized for high speed search operations, catering to a multitude of industry verticals.
  • Lighten Up!  Long-term imaging with ultra-bright, organic AIE cell trackers
    Lighten Up! Long-term imaging with ultra-bright, organic AIE cell trackers Liu Bin, PhD,Department Head - Department of Chemical and Biomolecular Engineering, National University of Singapore Recorded: Feb 22 2018 31 mins
    With the recent discovery of a special class of organic compounds with aggregation-induced emission (AIE) characteristics, new opportunities have opened for in vitro and in vivo imaging. In combination with advanced polymer encapsulation technologies, AIE compounds are now available as LuminiCell ultra-bright, organic nanoparticles that enable long-term cell tracking and imaging for applications such as cancer research and stem cell biology.
  • How Nanotech IP is influencing the whole semiconductor industry
    How Nanotech IP is influencing the whole semiconductor industry Dr.Shafiq Kabir CIO of Smoltek AB and Ruta @ PatSnap Recorded: Feb 21 2018 36 mins
    Many companies have influence in markets because they make essential products. Think about the products all around us the metals, plastics and various other materials that make up our world. We can see how a change in manufacturing processes or supply could influence the whole industry.

    We are joined by Dr.Shafiq Kabir, Chief Innovation Officer at Smoltek AB, to learn how companies who rely on only Intellectual Property are working to change the market. Smoltek specialises in nanomaterials and their applications and brings together industry, intellectual property and manufacturers together.

    This is essential viewing for anyone interested in nanomaterials/nanotechnology, IP, licensing and market penetration.
  • Need to judge your product? Use HPTLC to get insights into sample composition-S2
    Need to judge your product? Use HPTLC to get insights into sample composition-S2 Melanie Broszat, PhD CAMAG, Muttenz, Switzerland & Michaela Oberle Merck KGaA, Darmstadt, Germany Recorded: Feb 20 2018 56 mins
    Thin-Layer Chromatography has been a well-known method for analysis of botanicals and other complex samples since the end of the 1930s. Today’s modern thin-layer chromatography combines the advantage of analytical robustness and high sample throughput with the possibility to use all kind of specific detection methods, e.g. classical UV/Vis/Fluorescence detection, mass spectrometry or effect-directed analysis. This method increases the amount of information for a fast and efficient screening for new compounds and the identification of raw materials especially for samples with a high matrix load such as herbal drugs, cosmetic and food samples.
    HPTLC, the most advanced form of Thin-Layer Chromatography, is a powerful yet simple and cost effective tool for testing identity, purity, and strength (content) of botanicals as well as excluding adulteration during quality control. With the publication of general chapters by the United States Pharmacopoeia (USP ) and European Pharmacopoeia (Ph.Eur. 2.8.25) HPTLC has officially come into existence as a highly standardized and therefore reproducible analytical technique. The use of high performance plates, suitable instrument and software, a standardized methodology, and validated methods ensures reliable results that are fully compliant with current Good Manufacturing Practice (cGMP). HPTLC fingerprints allow convenient visual comparison of multiple samples even if those originate from different plates (and different laboratories worldwide). Reference images (HPTLC fingerprints of botanical reference materials or other references) can be used to qualify data and pass/fail samples based on similarity or difference.
    We will give you an overview about the versatility of HPTLC, applicable to many of your analytical tasks. Don’t miss the chance to extend your knowledge!
  • Need to judge your product? Use HPTLC to get insights into sample composition
    Need to judge your product? Use HPTLC to get insights into sample composition Melanie Broszat, PhD CAMAG, Muttenz, Switzerland & Michaela Oberle Merck KGaA, Darmstadt, Germany Recorded: Feb 20 2018 52 mins
    Thin-Layer Chromatography has been a well-known method for analysis of botanicals and other complex samples since the end of the 1930s. Today’s modern thin-layer chromatography combines the advantage of analytical robustness and high sample throughput with the possibility to use all kind of specific detection methods, e.g. classical UV/Vis/Fluorescence detection, mass spectrometry or effect-directed analysis. This method increases the amount of information for a fast and efficient screening for new compounds and the identification of raw materials especially for samples with a high matrix load such as herbal drugs, cosmetic and food samples.
    HPTLC, the most advanced form of Thin-Layer Chromatography, is a powerful yet simple and cost effective tool for testing identity, purity, and strength (content) of botanicals as well as excluding adulteration during quality control. With the publication of general chapters by the United States Pharmacopoeia (USP ) and European Pharmacopoeia (Ph.Eur. 2.8.25) HPTLC has officially come into existence as a highly standardized and therefore reproducible analytical technique. The use of high performance plates, suitable instrument and software, a standardized methodology, and validated methods ensures reliable results that are fully compliant with current Good Manufacturing Practice (cGMP). HPTLC fingerprints allow convenient visual comparison of multiple samples even if those originate from different plates (and different laboratories worldwide). Reference images (HPTLC fingerprints of botanical reference materials or other references) can be used to qualify data and pass/fail samples based on similarity or difference.
    We will give you an overview about the versatility of HPTLC, applicable to many of your analytical tasks. Don’t miss the chance to extend your knowledge!
  • 5 ways to successfully commercialise your intellectual property
    5 ways to successfully commercialise your intellectual property Annelie Viksten from AWAPatents | Carol David Daniel from City University | Duncan Clark from PatSnap Recorded: Feb 14 2018 59 mins
    In this webinar, PatSnap will be joined by Annelie Viksten, Carol David Daniel and Duncan Clark to explore what ingredients are needed to create an environment that promotes the best possible chances of market success for new projects.

    Other discussion points include:

    - The importance of a fully integrated, end to end commercialisation strategy
    - How to identify the differences between projects that create new revenue, versus those that don't.
    - How to extract more ROI from your existing intellectual property
    - Understanding the difference in approaches to innovation in academia, and the commercial world.
  • Efficient execution of biologics manufacturing – The role of Finite Scheduling
    Efficient execution of biologics manufacturing – The role of Finite Scheduling Gloria Gadea-Lopez, Ph.D., John Maguire and Megan Rabideau Recorded: Feb 14 2018 47 mins
    The success of manufacturing relies on the availability of all the resources –personnel, materials, equipment, work instructions - , orchestrated in such a way that the operations proceed in an efficient and predictable manner. This article describes the implementation of a finite scheduling system for biologics production, the foundational work required prior to project launch, lessons learned, and benefits achieved from this deployment.
  • Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing
    Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing Dr Joachim Walter Recorded: Feb 8 2018 38 mins
    Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.

    In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent.

    Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.
    This paper’s focus is on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.
  • Building a Data Forever Architecture
    Building a Data Forever Architecture Erik Ottem, Director Product Marketing, Western Digital Recorded: Feb 6 2018 27 mins
    Unstructured data has evolved into a business asset, creating the need to keep more data longer. The growth and diversity of unstructured, in the form of large media files, metadata, and complex business documents have created a strain on traditional storage infrastructures and IT budgets.

    In this webinar, our industry expert Erik Ottem will discuss the expanding role of unstructured data, the shortcomings of traditional storage architectures and the building blocks to capture, store and preserve data at scale and throughout its entire lifecycle.

    Register today and learn how to build a data forever architecture so your data can become a competitive advantage rather than a burden.
  • Do Extractable Protocols Truly Help- An End User Perspective
    Do Extractable Protocols Truly Help- An End User Perspective Ekta Mahajan, Genentech/Roche Recorded: Feb 5 2018 66 mins
    Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and patients continue to be one of the biggest challenges. The challenge is augmented by the lack of standardized methodology for suppliers to execute extractable studies that meets end user requirements. The end users are responsible and required by law to assess the impact of extractables and leachables on overall Product Quality and Safety. Due to lack of a standard, customized data had to be generated for/by each end users. This resulted in long lead times, higher costs and inefficient utilization of resources. Typically, the data generation and qualification of single use component can take up to a year, which can impact implementation of single use. BioPhorum Operations Group (BPOG) developed a standardized protocol9 for generating extractable data that would meet user requirements and simplify/reduce implementation time within industry. A standardized protocol gives confidence to suppliers that testing performed by them would meet end user requirements and enable faster implementation. Some suppliers shared the BPOG vision and proactively tested their single use components using BPOG protocol, which has helped expedite the use of their products.
  • HGST Ultrastar® Serv24-HA NVMe Storage Server
    HGST Ultrastar® Serv24-HA NVMe Storage Server Manfred Berger, HGST - Sr. Mgr. Business Development Platforms EMEAI Apr 25 2018 9:00 am UTC 45 mins
    In this webinar Manfred Berger introduces the latest addition to the HGST platform portfolio, the high availability Ultrastar® Serv24-HA NVMe all-flash storage server.

    Combining high performance NVMe™ SSDs and two redundant blade servers based on Intel®’s Purley architecture into one tried and tested unit, the Serv24-HA enables customers to come to market quickly with a multitude of dependable software defined storage solutions or data base servers optimized for high speed search operations, catering to a multitude of industry verticals.
  • Lymphomas and Leukemias
    Lymphomas and Leukemias Jeff Gordon Apr 27 2018 3:00 pm UTC 75 mins
    Leukemia and lymphoma are hematologic neoplasms that affect members of all age groups. Each year, over 140,000 people in the US are diagnosed with a hematologic malignancy of some kind. With constant advancement of treatment options, the importance of accurate diagnosis and detection of lymphomas and leukemias becomes more and more relevant to the survival of the patient, and immunohistochemistry has served as a key auxiliary test in determining these diagnoses. This presentation covers many of the basic science, facts, and statistics of hematologic malignancies, as well as the utility of immunohistochemical testing with markers such as CD20, PAX-5, CD61, CD71, Cyclin D1, and SOX-11 in the accurate diagnosis and survival rates of lymphoma and leukemia.
  • The Power of Scopus Data
    The Power of Scopus Data Holly J. Falk-Krzesinski, PhD, Vice President, Research Intelligence Global Strategic Networks, Elsevier May 3 2018 2:00 pm UTC 60 mins
    Scopus is considered the Gold Standard for research assessment and evaluation purposes by 4,500+ universities and 150+ leading research organizations worldwide. Join as us we discuss the richness of Scopus data and the value it provides for data-driven insight.
  • Using education and awareness to drive positive change for patients
    Using education and awareness to drive positive change for patients Gwen Nichols (LLS), Kathleen Weis (AAMDSIF), Brian Tomlinson (CancerCare), Gary Nolan (Know AML), Jenny Kite (Astellas) May 3 2018 3:30 pm UTC 75 mins
    Change Together will be presenting a live webinar with leading figures from the patient advocacy community, who will debate how we can drive positive change for patients through improved education and awareness. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.
    The panel and the topics they will be covering are as follows.
    • Dr. Gwen Nichols, Chief Medical Officer of the Leukemia & Lymphoma Society on coordinating the group’s groundbreaking Beat AML Master Trial, which is taking the latest research from the lab to the clinic.
    • Kathleen Weis, Chief Executive Officer of the Aplastic Anemia and MDS International Foundation, on the changing treatment landscape, which is bringing new hope to patients, and how her group is supporting the AML community.
    • Representatives from Know AML, the global AML awareness initiative established in 2017 – Gary Nolan from the Know AML secretariat and Brian Tomlinson, patient advocate committee member and Chief Program Officer at CancerCare – explaining how the project started and the role that patient advocates play in it.
  • Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test
    Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux May 4 2018 2:00 pm UTC 75 mins
    Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test
    Presenter: Karen Zink McCullough, MMI Associates
    The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge
    on LAL testing. Some of these gaps include: Guidance on RSE:CSE standardization, Guidance on Training,
    Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter, that will appear in the
    July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and
    more. This Webinar will provide an overview of the contents of this new informational chapter.

    Title: Regulatory Compliance of Alternative Methods
    Presenter: Kevin L. Williams, BIOMÉRIEUX
    Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste
    (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in
    2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device
    Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will
    provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP
    chapters < 1225 > and < 85 >.
  • 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 May 10 2018 2:00 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.
  • End User Perspective on Setting in-Process Endotoxin Limits
    End User Perspective on Setting in-Process Endotoxin Limits Dr Friedrich von Wintzingerode, Roche/Genentech May 15 2018 8:00 am UTC 75 mins
    There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This webinar will present a concept for setting in-process  limits and a case study which allows to understand the underlying rationales and challenges. 
  • Emerging biomarkers for the diagnosis of cardiac pathologies
    Emerging biomarkers for the diagnosis of cardiac pathologies Rich Triglia May 15 2018 3:00 pm UTC 75 mins
    According to the World Health Organization (WHO) cardiovascular diseases (CVD’s) are the leading cause of death accounting for more than 17.3M deaths globally. Modern cardiac diagnostics tests and monitoring techniques are providing ever increasing insight into the health of the human heart. In this presentation we examine some of the new and emerging cardiac biomarkers that could complement existing diagnostic and prognostic methods and have the potential to revolutionize our current understanding of cardiac health.
  • Knockdown, Knockout, Validate: Lentivirus delivers payload in vitro and in vivo
    Knockdown, Knockout, Validate: Lentivirus delivers payload in vitro and in vivo Christy Hoffmann May 16 2018 3:00 pm UTC 75 mins
    Whether you are looking to knockout, knockdown, or overexpress genes, lentiviral transduction is the superior mechanism for delivering genetic cargo into hard to transfect cells and in vivo systems. Lentivirus is a perfect tool for screening applications since the delivered genetic material is constitutively expressed by the cells long-term. We will discuss the flexibility of our expert manufacturing group and present examples of applications suitable with lentivirus.

    During this webinar, we dispel the preconceived misconception that lentivirus is risky or cumbersome to use. As a trusted lentiviral manufacturer, we will share our best practices for handling lentivirus and the simple steps that set you up for success.
  • Current Perspective on Rapid Sterility Test
    Current Perspective on Rapid Sterility Test David Roesti, PhD, Novartis Pharma AG  May 17 2018 2:00 pm UTC 75 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • 3D Imaging of 3D Cell Culture Models
    3D Imaging of 3D Cell Culture Models Tom Villani, Ph.D., Ann Rossi, Ph.D. May 17 2018 4:00 pm UTC 60 mins
    One of the obstacles to working with 3D cell cultures is how to extract meaningful data from them. To address this problem, Visikol has developed their Visikol® HISTO-M™ tissue clearing reagent that allows for complete 3D cell culture characterization using confocal imaging or a 3-fold increase in cells detected using wide-field microscopy. This tissue clearing approach has been developed to be rapid and compatible with multi-well plates so that it can be conducted using automated pipetting robots and high content confocal imaging systems.
    By attending this webinar you will learn about:
    • Methods to enable 3D cell culture
    • Ways to enhance imaging and characterization of 3D spheroids

    Presenter Bios:
    Dr. Tom Villani is the CSO and Co-founder of Visikol Inc and is responsible for the companies scientific strategy. Since launching Visikol with Co-Founders Dr. Michael Johnson and Nick Crider, Dr. Villani has led the development of the Visikol HISTO tissue clearing technology for three-dimensional tissue imaging as well as a suite of digital pathology tools. Visikol has leveraged these technologies in its 3Screen service offering where the company is focused on transforming tissues into actionable insights as a service for primarily pharmaceutical companies.

    Dr. Ann Rossi graduated from the University of Rochester School of Medicine and Dentistry with a Ph.D. in Pharmacology and received postdoctoral training at the University of Chicago. Prior to joining Corning, Ann worked as a Senior Scientist at ARMGO Pharma, Inc., a small private pharmaceutical company, contributing her expertise in calcium signaling toward developing new assays for the company’s screening cascade. Ann is new to Corning Life Sciences as the Applications Lab Manager in Kennebunk, Maine and is drawing on her strong academic and industry research experience to direct the activities of the applications group.
  • Implementation Strategies and Challenges for SUT at Commercial scale
    Implementation Strategies and Challenges for SUT at Commercial scale Adam Goldstein, Roche/Genentech May 17 2018 5:00 pm UTC 75 mins
    For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.

    While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.

    In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.
  • Precision genome editing in macrophage and CD8+ human primary T cells for immuno
    Precision genome editing in macrophage and CD8+ human primary T cells for immuno Laura Daley, PhD May 22 2018 1:00 pm UTC 75 mins
    Innate immune cells play a critical role in cell-mediated immunity and have the potential to serve as cell-based therapies to treat a broad spectrum of immune diseases such as cancer and autoimmune disorders. Modified immune cells, such as genetically engineered CAR-T cells, have proven to be critical in developing new cell-based therapies for these diseases. However, immune cell biology creates challenges during the gene-editing process that lead to hyper-regulated RNA and DNA sensing pathways and enhanced cell death upon introduction of exogenous ribonucleotides. Further, engineering in primary immune cells is often restricted due to their limited expansion capacity. Genetic engineering in immune cells has traditionally relied on random integration of gene-editing components using viral delivery systems. In contrast, genome editing mediated by nucleases, such as CRISPR/Cas9-single guide RNPs, provide a platform for precision editing, and alleviate the potential side effects caused by randomly integrated viral DNA. While RNP gene editing in immune cells is just beginning to be considered by the immune-therapeutics field, our recent advances demonstrate that this approach can be used to create targeted modifications in two key cell types, the macrophage and the CD8+ primary T-cell. In an effort to circumvent challenges with the finite lifespan of primary T-cells, we targeted genes to edit that rendered this cell type “pseudo-immortalized”, allowing additional passages for further downstream genome editing and propagation. In addition, we demonstrated that precision editing can be used to introduce disease relevant SNPs into the macrophage genome, which resist introduction of exogenous ribonucleotides due to the induction of apoptotic pathways. Advances such as these overcome many of the obstacles currently faced with immune cell editing and offer improved gene stability and expression in immune cells and will transform the Immuno-Oncology and Gene Therapy fields.
  • Precision genome editing in macrophage and CD8+ human primary T cells for immuno
    Precision genome editing in macrophage and CD8+ human primary T cells for immuno Laura Daley, PhD May 22 2018 5:00 pm UTC 75 mins
    Innate immune cells play a critical role in cell-mediated immunity and have the potential to serve as cell-based therapies to treat a broad spectrum of immune diseases such as cancer and autoimmune disorders. Modified immune cells, such as genetically engineered CAR-T cells, have proven to be critical in developing new cell-based therapies for these diseases. However, immune cell biology creates challenges during the gene-editing process that lead to hyper-regulated RNA and DNA sensing pathways and enhanced cell death upon introduction of exogenous ribonucleotides. Further, engineering in primary immune cells is often restricted due to their limited expansion capacity. Genetic engineering in immune cells has traditionally relied on random integration of gene-editing components using viral delivery systems. In contrast, genome editing mediated by nucleases, such as CRISPR/Cas9-single guide RNPs, provide a platform for precision editing, and alleviate the potential side effects caused by randomly integrated viral DNA. While RNP gene editing in immune cells is just beginning to be considered by the immune-therapeutics field, our recent advances demonstrate that this approach can be used to create targeted modifications in two key cell types, the macrophage and the CD8+ primary T-cell. In an effort to circumvent challenges with the finite lifespan of primary T-cells, we targeted genes to edit that rendered this cell type “pseudo-immortalized”, allowing additional passages for further downstream genome editing and propagation. In addition, we demonstrated that precision editing can be used to introduce disease relevant SNPs into the macrophage genome, which resist introduction of exogenous ribonucleotides due to the induction of apoptotic pathways. Advances such as these overcome many of the obstacles currently faced with immune cell editing and offer improved gene stability and expression in immune cells and will transform the Immuno-Oncology and Gene Therapy fields.
  • Environmental Monitoring Trend Analysis Tools
    Environmental Monitoring Trend Analysis Tools Steve Walton May 23 2018 2:00 pm UTC 75 mins
    Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.
  • Custom Assay Development and Services utilizing Single Molecule Counting (SMC™)
    Custom Assay Development and Services utilizing Single Molecule Counting (SMC™) Sarah Hamren, Head of Custom Assays & Sample Testing, Merck KGaA, Darmstadt, Germany May 23 2018 2:00 pm UTC 75 mins
    Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. When time and resources are limited, Merck KGaA offers a comprehensive portfolio of Custom Services supported by a scientific team with core expertise in SMC™ technology. Learn how our team will partner with you to develop a project specific to your requirements, whether that is fit-for-purpose sample testing, biomarker analysis using our current SMC™ immunoassays, or development and manufacture of an immunoassay for your novel target of interest. Learn how we work with our clients to define and tailor a customized project plan that includes milestone driven tasks, collaborative data review and progress reports. Whether your focus is to expedite your clinical research or to transfer a method to a CRO, we will show you how our services can help you accelerate programs from discovery into clinical trials.
  • Chemical disruptors and their uses in failing drug discovery
    Chemical disruptors and their uses in failing drug discovery Roshan Jumnah and Ruta Sudmantaite @ PatSnap May 23 2018 3:00 pm UTC 60 mins
    Modern drug discovery appears in many ways to be well-defined with tried-and-tested approaches to acquire success. For example, efforts in combating antibiotic drug resistance usually results in the attempted discovery of new classes of antibiotics.

    However, such unquestioned convention has often, as in the example with antibiotics, led to very few new discoveries and even stagnation of an entire research area. We ask the question: does it have to be this way?

    One method to re-boot a failing area of research is to stop following convention and employ disruptive chemical methods and thinking to kick-start a process of rejuvenation. In this webinar, we will focus on the areas of antibiotic resistance, drug metabolism and accelerated polymer drug discovery, where chemical disruptors and new thinking could impart a positive outcome.

    We will identify the chemical disruptors, their uses and the potential consequences of utilising these methods.
  • Custom Assay Development & Services utilizing Single Molecule Counting (SMC™)2
    Custom Assay Development & Services utilizing Single Molecule Counting (SMC™)2 Sarah Hamren, Head of Custom Assays & Sample Testing, Merck KGaA, Darmstadt, Germany May 24 2018 12:30 am UTC 75 mins
    Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. When time and resources are limited, Merck KGaA offers a comprehensive portfolio of Custom Services supported by a scientific team with core expertise in SMC™ technology. Learn how our team will partner with you to develop a project specific to your requirements, whether that is fit-for-purpose sample testing, biomarker analysis using our current SMC™ immunoassays, or development and manufacture of an immunoassay for your novel target of interest. Learn how we work with our clients to define and tailor a customized project plan that includes milestone driven tasks, collaborative data review and progress reports. Whether your focus is to expedite your clinical research or to transfer a method to a CRO, we will show you how our services can help you accelerate programs from discovery into clinical trials.
  • Current USP Perspectives on a Rapid Sterility Test
    Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP May 30 2018 8:00 am UTC 75 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • Extractable Study Design & Data Evaluation of Polymeric Product Contact Material
    Extractable Study Design & Data Evaluation of Polymeric Product Contact Material Dr. Ping Wang, Principal Scientist, Janssen R&D Jun 5 2018 2:00 pm UTC 75 mins
    Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especially single use systems, in the manufacturing, packaging and delivery of biologics have increased in recent years. Based on surveys and author’s experience, almost all major regulatory agencies require the E&L risk assessment of PCM for new biologics license applications (BLA). To ensure the E&L data are suitable for the assessment of intended application of the PCM, the health authorities are paying close attention to the study design, analytical assays employed, and how the extractable data being used to conduct a safety risk assessment of the materials. The key to the success is to ensure the study design and data interpretation is product and process specific. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the toxicological evaluation will be discussed.
  • Finding the Common Road to Quality for Single Use Materials
    Finding the Common Road to Quality for Single Use Materials Presented by Dr Trishna Ray-Chaudhuri, Genentech Jun 6 2018 4:00 pm UTC 75 mins
    - GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing.  The drug product produced in clinical studies are given to patients.

    - GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products. 

    IF WE CAN”T PROVE GMP WHAT HAPPENS?

    -Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks.

    -The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed.

    - Implementation of single will be inhibited
  • Subvisible Particles Matter, Developments in Regulations and Low Volume Methods
    Subvisible Particles Matter, Developments in Regulations and Low Volume Methods Dr Satish K Singh, Lonza Jun 7 2018 2:00 pm UTC 75 mins
    The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP is a new chapter that addresses the limitations of USP for therapeutic proteins in measurement of subvisible particles. USP is a guidance chapter addressing the task of characterization of particles with the emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.
  • Advances and Challenges in Vaccine Development and Manufacture
    Advances and Challenges in Vaccine Development and Manufacture Tony D’Amore, Sanofi Pasteur Jun 11 2018 2:00 pm UTC 75 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.
  • Fully continuous biosimilar manufacturing framework: A case study
    Fully continuous biosimilar manufacturing framework: A case study Samir Varma Jun 14 2018 8:30 am UTC 75 mins
    Biologics manufacturing has traditionally been in fed batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and mabs became more stable, perfusion was replaced by fedbatch technology, as they were simpler to scale up. However, during the past 2-3 years, the perfusion technology is making a comeback due to the novel continuous chromatography technology. Connecting the perfusion bioreactor to the continuous chromatography system creates a continuous flow of drug substance and promises the following advantages

    The facility footprint for a continuous manufacturing plant would be substantially lower. Our calculations show that a 10-fold reduction in bioreactor size is possible with continuous bioprocessing. So the capacity of a 2000L Fed batch Bioreactor can be achieved by a 200L continuous bioreactor. This reduces the capex by about five fold.
    Consumption of media per amount of DS produced is the same for fedbatch and perfusion, although the cost per liter might be lower for perfusion as it could be a more diluted version of the fedbatch media ,
    Another major cost in bioprocessing is the Protein A resin. A significantly smaller Protein A column could be used in the continuous process and the utilization could be maximized by this strategy.
    As the process is more dynamic in continuous, automation and in-line analytical tools are essential for the successful implementation.
    Enzene Biosciences is on the forefront of the development of the continuous bioprocessing. We are in the processing of building a cGMP plant that would have a fully integrated continuous bioprocess. We have already complete a proof of concept studies in pilot scale (50L)
  • Manufacturing strategies for Biosimilar: A case of continuous capture
    Manufacturing strategies for Biosimilar: A case of continuous capture Solomon Alva, Biocon Jun 15 2018 8:30 am UTC 75 mins
    Continuous manufacturing is an emerging technology in biopharmaceutical industry. The focus of this webinar is a case-study on the benefits of continuous Protein A capture on productivity, capacity utilization and buffer consumption. The potential challenges of adopting the technology such as its integration with cell culture and low pH incubation step has been discussed. There is promise of this technology as an effective platform, and potential of additional savings when considering new generation Protein A resins and in-line concentration technologies.