Get powerful life science insights from influential experts. Connect with thought leaders and colleagues to get the most up-to-date knowledge on strategies and initiatives to accelerate the transformation of U.S. and global health care from a volume- to value-based marketplace.
It is now recognized that target and compound identification, as well as validation, are better conducted using cells with physiologically relevant phenotypes and genotypes. This assertion has accelerated the adoption of primary cells, stem cells, or patient-specific cells in cellular research, in general; and drug discovery, in particular.
Technological improvements in three-dimensional (3D) cell culture technology, as a means to better mimic in vivo physiology, have accelerated recently—not only in the areas of cancer and neurological research, but also for the assessment of compound metabolic and toxicological liabilities. Furthermore, 3D cell culture can provide novel approaches to the scale-up and manufacture of biologically based medicines, including those used in immuno-and stem cell-based therapies.
In this presentation, the existing and future impact of 3D cell culture technology on fundamental research, and drug discovery and manufacture will be addressed, particularly in the context of using phenotypically relevant cells. Specifically, it will discuss the potential for spheroids, organoids, scaffolds, and hydrogels in cellular research and compound identification, screening, and development.
Future directions will also be covered, including organs-on-chips, hydrostatic flow technologies, microfluidics, and 3D bioprinting. Some of these approaches will allow for real-time observation of cellular responsiveness to novel compounds and drugs … boldly taking the researcher into a fourth dimension of 3D cell culture!
Mass spectrometry-based protein assays impart increased specificity and more rapid development times versus traditional methods, such as ELISA. Coupled with immunoaffinity enrichment, LC-MS/MS is becoming a powerful tool for the quantitation of proteins in plasma. Such methods typically rely on synthetic stable isotope labeled (SIL) peptide internal standards to correct for instrumental variability. For more accurate protein quantitation by LC-MS/MS, experimental variations throughout the entire sample preparation workflow, including protein fractionation, immunoaffinity enrichment, and enzymatic digestion, must be accounted for. An ideal way of improving assay reproducibility is to add a full-length stable isotope labeled recombinant protein, that is equivalent to the native target protein, to the sample at the initial stage of the assay workflow. We have developed a set of stable-isotope-labeled monoclonal antibodies expressed in CHO cells as well as SIL versions of several clinically-relevant human proteins expressed in E. coli, such as IGF1, and in mammalian HEK293 cells, such as Thyroglobulin (manufactured as a Certified Reference Material). We will present data to demonstrate that the use of full-length SIL proteins and antibodies as internal standards allows for more accurate and rapid quantitation of biotherapeutic antibodies and clinically-relevant human protein biomarkers in plasma by LC-MS/MS.
Damage, counterfeit, theft, delays: these are some of the most pressing challenges that pharma supply chain executives are facing. Consequences are not limited to disruptions and to higher costs for manually managing exceptions, identify irregularities, and tracing products: there's also direct impact on patient safety, and customer satisfaction putting company reputation at risk.
In this webinar IDC analysts will share its research findings and provide guidance to pharmaceutical executives that want to start harnessing the real value of third generation digital platform, and implement a consistent, efficient and future-ready approach to supply chain management.
About the Speakers:
Silvia Piai is Senior Research Manager within IDC Health Insights for Europe Middle East and Africa. She is responsible for analyzing key trends related to IT strategies and spending in European healthcare organizations, and global Public Health institutions. She advises healthcare organizations and ICT vendors on planning and implementing effective digital health transformation initiatives to drive business innovation. Silvia’s analysis offers in-depth coverage of the technologies that provide the most clinical value in terms of quality, cost, time, and agility and are transforming pre-care, point of care (POC), and post-care today.
Stefanie Naujoks is Senior Research Manager within IDC Manufacturing Insights, where she leads a new global program on Manufacturing Business Ecosystems Strategies. Her research includes managing supply networks, selling into new business ecosystems and manufacturing B2B Commerce, enabling better ecosystem collaboration through industry collaborative clouds, as well as automation and transparency within business ecosystems. Stefanie has published numerous market studies in the fields of digital transformation, IoT, Industry 4.0, Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES) and Supply Chain Management (SCM).
Pharmaceutical marketers are increasingly native multichannel practitioners, but building an effective and efficient campaign is challenging.
This is also because the digital landscape, and the number of options available is still rapidly evolving.
What are the best ways to choose the right channels and the right content? And how can you plan to optimize operations further by cutting down on costs and approval times?
This webinar brings together experts in digital marketing with case studies from a leading pharmaceutical company to keep you up to date with the latest technology and trends and provide practical advice on how to maximize your impact.
Within one hour, you’ll discover how to optimize and streamline all content-related processes within a single platform: starting with concept development and ending with the final launch. What is more, you will find out how to reuse and repurpose your ready-made content cost-effectively, as well as save time while adapting and updating content through its whole lifecycle.
•How to develop best practice and a winning multichannel strategy
•Making sure your content supports face-to-face interactions
•Transforming the commercial teams to deliver successful digital and multichannel projects
•How to innovate in multichannel, and the potential of future integration solutions
ADCs are complex compounds resulting from the coupling of cytotoxic small molecules to a monoclonal antibody. Their characterization as well as their bioanalysis (quantification in biological fluids) remains challenging. Mass spectrometry at different levels (intact, middle, peptide) can be a valuable tool, and can now be used in a regulated environment thanks to advances in both hardware and software.
Watch this on-demand webinar with DocuSign and Xconomy to learn about the latest research on alternative financial models for drug development. You will also learn how you can speed up contract and approval cycles by using an eSignature solution for everything ranging from clinical trials to distribution when bringing new products to market.
Across Europe, a shift towards greater prevention, earlier diagnosis and treatment is needed in order to contain the growing cost of healthcare.
But how can healthcare systems make this transition – and how do pharmaceutical companies play a role in this, while also growing their market?
A forthcoming webinar hosted by pharmaphorum with sponsor PHOENIX group looks at how harnessing the data and expertise of pharmacies, and via greater engagement with patients, consumers and shoppers can meet this emerging need.
•Industry: how can pharma switch from treating a disease to earlier health management?
The role of preventative medicine, vaccines and early diagnosis explored
•The role of community pharmacies in prevention and health – increasing screening and diagnosis rates and facilitating appropriate medication
•How point of sale information in pharmacies can help generate a picture of patient groups and individuals. How loyalty card schemes support OTC and consumer spending patterns, which illuminate health needs, prescription patterns and purchasing behaviour
Historically, quality of biological products has been ensured through testing representative samples. Shift in quality paradigm started with implementation of Good Manufacturing Practice (GMP) regulations with current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing Quality by design (QbD) concept. This presentation discusses ways to build quality during manufacture of biological products.
Developments for new therapeutics to target various aspects of auditory system dysfunction is on the rise within the drug development industry. Join Rachel as she reviews nonclinical auditory safety programs, including standard and non-standard endpoints. She will also share in-depth answers to common questions regarding species selection and study timelines.
PlumX Metrics will soon become the primary source of article-level metrics on Scopus. As Plum Analytics’ comprehensive, item-level Metrics, PlumX Metrics provide insights into the ways people interact with individual pieces of research output (articles, conference proceedings, book chapters and many more) in the online environment.
Having an agile, enterprise hybrid cloud platform that lets you leverage cloud compute, storage, or both and keep data where it makes the most sense—without lofty storage costs, latency, and security concerns.
In this webinar, you’ll learn how organizations with complex IT environments like the Cancer Center harness hybrid cloud environments to simplify data storage and management, and improve both security and performance. Find out how Avere and Amazon Web Services (AWS) provide hybrid cloud solutions that can eliminate roadblocks and open opportunities to more efficiently meet the needs of your users and customers.
Dirk Petersen, Scientific Computing Director, Cancer Research Center
Jeff Tabor, Sr. Director of Product Marketing, Avere Systems
Ian Scofield, Solutions Architect, Amazon Web Services
U.S. consumers rate national security in relation to war or terrorism as their top security concern, though fears over viruses/malware and hacking are rising dramatically, according to the new Unisys Security Index™ that surveyed more than 13,000 consumers in April 2017 in 13 countries. This study, the only recurring snapshot of security concerns conducted globally, gauges the attitudes of consumers on a wide range of security-related issues.
About the speaker:
Bill Searcy is the Vice President for Global Justice, Law Enforcement, and Border Security Solutions. As a recognized law enforcement solutions expert, he is responsible for developing market strategies, overseeing delivery, ensuring customer satisfaction, and driving business performance to meet goals.
During his 21-year career as a Special Agent with the Federal Bureau of Investigation, Bill was recognized as an innovator who regularly sought new ways to use technology to solve complex problems. He is credited with leading numerous award winning IT initiatives, among them the FBI’s Grid Computing Initiative (Attorney General’s Award for Innovation) and the Next Generation Workstation (FBI Director’s Award).
Prior to joining Unisys, Bill served as the Deputy Assistant Director of the FBI’s IT Infrastructure Division, where he was responsible for the engineering, development, deployment, and support of the FBI’s worldwide IT enterprise.
A graduate of the United States Military Academy at West Point, Bill was commissioned as an officer in the U.S. Army where he commanded a Field Artillery battery. He went on to earn a Master of Science in Information Assurance from Norwich University and he is a Certified Information Systems Security Professional (CISSP).
1. The kidney proximal tubule is the primary site of drug-induced nephrotoxicity. I will describe the development of a 3-dimensional flow-directed proximal tubule microphysiological system (MPS). The kidney MPS recapitulates the synthetic, metabolic and transport activities of kidney proximal tubule cells. This MPS is as an ideal platform for ex vivo modeling of nephrotoxicity. Towards this goal, we have evaluated nephrotoxicity in response to challenge with multiple toxicants, including the heavy metal pollutant cadmium, antisense oligonucleotides, the antibiotic polymyxin B and the Chinese herbal product aristolochic acid. We believe that MPS technologies will have major impacts on predictive toxicity testing and human risk assessment. Animal and in vitro systems do not always faithfully recapitulate drug and xenobiotic responses in the clinic or occupational/environmental exposures, respectively. MPS technologies will refine safety assessment and reduce our need for surrogate animal testing. An ultimate goal is to create integrated human MPS organ systems that could replace animal models.
2. Nortis has developed a technology that is used to recapitulate functional units of human organs in microfluidic devices (chips). Such organ models include vasculature, kidney, and liver models for toxicology studies, blood-brain barrier models for drug transport studies, and vascularized tumor microenvironment models for drug efficacy studies.
Cabells introduces two new important features: the Journal Blacklist, the only blacklist of deceptive and predatory academic journals, and Altmetric Reports, a measurement of journal media mention data. Join us to learn more about these and other key resources while getting familiar with the new Cabells brand identity and website interface.
Join Cabells Senior Project Manager Lucas Toutloff who will present the following:
•A demonstration of the Journal Whitelist — our curated, searchable database of over 11,000 journals covering 18 disciplines — connecting researchers, librarians, and administrators to verified, reputable publications. Backed by our newly designed journal summaries presenting our suite of journal quality metrics, now including Altmetric Reports.
•A demonstration of our newly released Journal Blacklist, the industry's only data-driven listing of likely deceptive or fraudulent academic journals. Built on objectivity and transparency, specialists analyze journals against over 60 behavioral indicators to keep the community abreast of the growing threats and to keep researchers protected from exploitative operations.
•An introduction to the new Cabells brand identity, website interface and features, and redesigned journal entries.
CiteScore 2016 annual values were recently released for over 22,600 titles. Additionally, a number of improvements have been made to CiteScore based on user feedback. Join us for a discussion with time for questions and answers!
Solid phase microexatraction or SPME is a green method for extraction of analytes out of a sample. Since SPME is a non-exhaustive extraction technique, some analysts believe that SPME is not quantifiable. This presentation will provide basic information for developing a method to extract and quantify analytes using SPME. Examples will be given on the extraction and quantification of analytes out of various matrices, and SPME will be compared to other extraction techniques such as QuEChERS and SPE. In this webinar, we will discuss some new SPME technologies such as SPME-OC (over-coated) fibers and BioSPME that help to isolate and quantify analytes from interfering compounds in the matrix. Guidelines will be provided for enhancement of precision using SPME.
Connected medical devices are playing a fundamental role in transforming patient care quality and experience and healthcare providers efficiency.
But as the number and the variety of devices grow within the organization, medical devices and the broader IoT ecosystem become more complex to manage, impacting patient safety, information security, compliance and financial performance.
In this webinar IDC Health Insights will share its research findings and provide guidance to health executives that want to start harnessing the real value of medical devices, by implementing a evidence based, consistent, controlled and efficient IoT management approach
About the speaker: Silvia Piai is Senior Research Manager within IDC Health Insights for Europe Middle East and Africa.
She is responsible for analyzing key trends related to IT strategies and spending in European healthcare organizations, and global Public Health institutions. She advises healthcare organizations and ICT vendors on planning and implementing effective digital health transformation initiatives to drive business innovation.
Silvia Piai has a more than 10 year experience in healthcare IT research. She started her career as public sector analyst, for then specializing in healthcare and becoming the lead analyst for the European healthcare market for IDC Health Insights. In her role, she focuses on the impact of digital transformation of healthcare and the role of technology in key industry trends as personalization and integration of care.
Her analysis offers in-depth coverage of the technologies that provide the most clinical value in terms of quality, cost, time, and agility and are transforming pre-care, point of care (POC), and post-care today. Analyzing the adoption and the investment plans of healthcare organizations, Silvia describes the evolution of healthcare IT and gives key insight on primary factors shaping the industry and the implications for the coming year future.
The benefits of three dimensional (3D) cell culture are widely appreciated. More cell-based technologies are now becoming available that enable researchers to preserve the native 3D structure of cells in vitro. These can be broadly divided into three areas: aggregate-based methods; hydrogels and extra-cellular matrices; and inert scaffold-based technologies. Each has strengths and weaknesses and there is no one technology that satisfies all applications. Tissues in the body are mostly composed of different cell types that are often highly organized in relation to each other. Often cells are arranged in distinct layers that enable signalling and cell-to-cell interactions. Alternatively in tumours, cancer cells form aggregates and tissue masses composed of different cell types. Recreation of these types of architecture will significantly evolve 3D cell culture to a new level where real tissue-like structures can be generated in vitro.
This webinar will review the alternative approaches available to researchers and provide an overview of their capabilities and example applications. More sophisticated models are developing as 3D cell culture technology becomes established and accepted as a means of creating more physiologically relevant cell-based assays. Methods that are relatively straightforward to use and that recreate the organized structure of real tissues will become valuable research tools for use in discovery, validation studies, and modelling disease.
Key areas covered:
• 2D vs 3D cell culture debate
• Review of alternative approaches and the development of new technologies
• Challenges facing 3D culture methods, in terms of technologies available and methods used
• Showcase applications where 3D technology makes a difference
• Future perspective for 3D cell culture technology and further development
With a wealth of market and regulatory changes impacting the medtech sector, it’s time for digital technology to steer the direction of your future business. This expert webinar will evaluate how to strategically embed digital within your own organisation and explore the challenges and the opportunities for transforming customer relationships, driving commercial outcomes.
– Respond to the changing regulatory environment: how technology empowers your business
– Build a business case for digital transformation and gain organisational support
– Strengthen your customer relationships and improve engagement in a diverse payer landscape
– Learn from pharma (and other industries) to find opportunities and avoid pitfalls
– Measure impact and return on investment from digital engagement
Nearly 70 percent of business data contains some level of location information. But business analysts rarely use this data within their BI and analytics workflows.
Location analytics is more than just putting points on a map. It’s part of a much larger picture of using location to provide context in visualizations, reports and analytics. Utilizing geographic data in descriptive and predictive analytics helps companies discover new patterns, identify location-specific opportunities, and get a complete picture before making business decisions.
In this webinar, Esri and SAS discuss the role that location analytics can play in determining practical next steps for your organization. A product demonstration will be shown as well.
• How does location analytics add value to BI and analytics initiatives?
• What are the right uses for location analytics?
• What pitfalls should organizations consider as they implement processes and technology for analyzing geographic data?
• Are special skill sets required to use location information?
• How can organizations best develop a strategy for using geographic data?
A poor animal welfare program can derail your preclinical research. Join Chris Dillon as he examines the importance of animal welfare as it relates to drug development costs, compliance, and factors for considerations when outsourcing preclinical programs.
Does western blotting give you more trouble than expected? Do you feel like your precious samples are being wasted on bad westerns? Join us and find out how you can improve your western blots! In this seminar, you will learn general guidelines for performing and troubleshooting your westerns, such as:
• Choice of different blotting membranes
• Parameters affecting blotting efficiency
• Conditions for optimizing your immunodetection
• Information on SNAP i.d.® 2.0 system: A faster way to perform immunodetection
A digital debate analysing the future for biologics in the UK and the factor affecting market access in this territory. Our expert panel will cover a number of key topics including:
•Are the savings offered by biosimilars being used to innovate and take advantage of the exciting new biologic technologies or just filling in the NHS potholes?
•Will the industry continue to invest in cutting-edge research if the UK is not prepared to fund access to it
•In a post-Brexit world how can the UK continue to be a global leader at the cutting edge of biologics research?
Scopus has recently added over 195 million more cited references dating back to 1970 to complement the database's existing records that date back 1788 and further increase the depth of content.
Added cited references mean:
•more extensive bibliometric and historic trend analysis
•more complete author profiles
•improved h-index measures for authors who began publishing prior to 1996
Learn more about the depth of Scopus content along with more insights into our content policies, selection criteria and data quality.
¡Conozca las preocupaciones de sus clientes y actúe!
El Unisys Security Index mide las preocupaciones de los consumidores en problemas relacionados a la seguridad nacional, personal, financiera y en Internet. El Índice Global de Seguridad mostró en 2017 un aumento de 20% en la preocupación general de seguridad. Aprenda más en este webinar sobre los detalles del estudio, cómo hacer frente a ciber amenazas, qué opinan los consumidores sobre el Internet of Things, y gánese la confianza de sus consumidores mientras continúa su proceso de Transformación Digital.
Leonardo Carissimi, Experto en Seguridad y Director de Soluciones de Seguridad en América Latina de Unisys. Cuenta con más de 20 años de experiencia en la industria de seguridad. En Unisys, ayuda a construir un mundo más seguro mientras transforma la industria de seguridad con el innovador enfoque de micro-segmentación, así como con la Arquitectura de Seguridad Adaptativa y la Inteligencia de Ciber-Amenazas.
Saiba mais sobre as preocupações dos seus consumidores!
O Unisys Security Index mede as preocupações dos consumidores em questões relacionadas à segurança nacional, pessoal, financeira e da Internet. O Unisys Security Index mostrou um aumento de 20% na preocupação de segurança geral em 2017. Saiba mais neste webinar onde iremos apresentar os detalhes do estudo e falar sobre como lidar com ameaças cibernéticas, o que os consumidores pensam sobre Internet das Coisas, e como aumentar a confiança de seus consumidores enquanto sua empresa avança na Transformação Digital.
Leonardo Carissimi, Especialista em Segurança e Diretor de Soluções de Cybersecurity para América Latina da Unisys. Possui mais de 20 anos de experiência no setor de segurança. Na Unisys, ajuda a construir um mundo mais seguro, ao mesmo tempo em que transforma o setor de segurança com uma inovadora abordagem de microssegmentação, bem como a arquitetura de segurança adaptativa e a inteligência de ameaças cibernéticas.
We hope you join us for this special webinar. Jeff Irelan, Director of Scientific Applications for Organovo will be our guest presenter.
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disorder with an estimated prevalence of over 25% worldwide and is projected to become the leading indication for liver transplant by 2025. Despite decades of research focused on NAFLD, an effective treatment has yet to be approved. This is due in part to the reliance on cell culture and animal models that present challenges in translation due to limited functional longevity and species differences, respectively.
ExVive™ 3D Bioprinted Human Liver Tissue, a clinically-translatable in vitro model, is ideal for studying the effects of drugs on liver disease progression, regression, and the mechanisms involved. Here, we present results showing a nutrient overload induction of liver disease and TGFβ-induced fibrosis in ExVive™ Human Liver Tissue. A variety of disease-relevant phenotypes including steatosis, inflammation, and fibrosis can be demonstrated in the model:
•Nutrient overload leads to the accumulation of lipid droplets in hepatocytes.
•Incorporation of Kupffer cells and stimulation induces inflammatory cytokine release.
•Chronic exposure to nutrient overload leads to stellate cell activation and fibrosis.
•Chronic exposure to chemical inducers of fibrosis or TGFβ stimulation leads to stellate cell activation and fibrosis.
•A TGFβR1 kinase inhibitor effectively blocks TGFβ-induced fibrosis.
Jeff Irelan holds a Ph.D. in molecular biology from the University of Oregon. As Director of Scientific Applications, Jeff interfaces with Organovo’s customers and R&D team to implement and expand the company’s portfolio of service offerings utilizing bioprinted tissue models.
Dr. Gert-Jan van de Geijn, renowned hematology expert, researcher and industry leader, will discuss new chronic obstructive pulmonary disease (COPD) test parameters that better discriminate between bacterial and nonbacterial acute exacerbation. Dr. van de Geijn will share how neutro/lympho ratios and basophils (measured by flow) combined with current C-reactive protein (CRP) tests enable more accurate bacterial detection in COPD patients.
After this live webinar, you will be able to:
-Assess options based on the limitations of current differentiation tests (e.g., sputum culture and CRP)
-Apply multivariate analysis results from hematology and flow cytometry technologies to increase specificity
-Combine tests to improve prediction of bacterial exacerbation in COPD patients to help reduce antibiotics resistance
A live Q&A session will follow.
P.A.C.E. credit is available for your participation.*
Gert-Jan van de Geijn, Ph.D., has nearly 20 years of experience in hematology and laboratory medicine. He is a specialist in multiple technologies related to cellular analysis, including both flow cytometry and molecular biological techniques. He has published and contributed to more than 30 research articles. Currently, Dr. van de Geijn is a research coordinator for the Department of Clinical Chemistry at Franciscus Gasthius Hospital, Rotterdam, the Netherlands.
*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. 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.
Following a decade (or more) of concerted effort by industry, regulator, and academic groups, recent technology investments are now beginning to shape how medicines are being developed and manufactured for the global marketplace. While significant focus has highlighted the emergence of continuous manufacturing processes, three additional trends have also influenced and served as underlying drivers for these technology investments. First, the emergence of scientific advances in targeted biology has created high-value personalized medicines with smaller manufacturing volumes (doses/annum). Second, new regulatory pathways, such as the FDA’s Breakthrough Therapy designation, have accelerated the development and commercialization timelines for these new medicines. Finally, manufacturing localization has extended supply chain networks to serve globally-distributed patient populations throughout the world. Together, these drivers have served to shape the future of pharmaceutical development, manufacturing, and distribution of a variety of different dosage forms. The increasing need for product development speed and commercial supply flexibility through small-footprint, modular equipment trains will be highlighted within this paper, using an immediate-release solid oral dosage form example.
Patient insights aren’t just a ‘nice to have’: they are essential to understand the space where Pharma’s drugs ‘live’.
On the 10th October, Cello Health Insight in association with PMGroup, will look at the value of three areas of patient research that provide that ‘must have’ understanding: mapping the patient pathway, patient motivation, and the dialogue between patient and HCP.
Unisys advises banks, non-bank lenders, insurers, and payments providers developing data management and artificial intelligence capabilities. This webinar will showcase client examples applying machine learning and predictive analytics to optimize consumer engagement, identify fraud and cyber security risks, and bring new capabilities to credit modeling.
About the Speakers:
Rodrigo Fontecilla is vice president and global lead for analytics for Unisys Federal Systems, where he leads all aspects of software development, system integration, mobile development, and data management focused on the federal government. Rod is responsible for providing leadership, coordination, and oversight on all IT solutions, emerging technologies, and IT services delivery to the federal government. He has more than 25 years of professional experience in the capture, design, development, implementation, and management of information management systems delivering mission-critical IT solutions and has an extensive background and expertise in cloud computing, mobile development, social media, enterprise architecture, data analytics, SOA-based solutions, and IT governance.
Maria L. Allen is Senior Director and Global Head of Unisys' Financial Services Portfolio Solutions. In this role, Maria is responsible for building new products and services across all regions, platforms and channels ensuring that solutions and services are delivered in a way that enable our clients to meet their strategic goals and objectives.
This webinar will provide an overview of recent advances in RAFT agents (900150, 900157 and 900158). New dithiocarbamate RAFT agents are extremely versatile, RAFT agents with wide-spread monomer applicability. The RAFT agents have the distinct advantage of low odour levels and in addition to this and the derived polymers do not develop odour on storage as no low molar mass thiols are generated. In most cases they are an appropriate replacement for trithiocarbonate RAFT agents. The new RAFT agents have the ability to control polymerization of both MAMs (more activated monomers) and LAMs (less activated monomers) and have been shown to be suitable for the synthesis of poly(MAM)-block-poly(LAM), specifically poly(DMA)-blockpoly(VAc).
In this webinar, we dive deeper into analytics and talk about the advantages of data exploration and predictive modeling. We’ll also show attendees how to fine-tune the accuracy and precision of those analytic models so you can make critical decisions with confidence.
McCann Health partnered with McCann Truth Central, the global intelligence unit of McCann Worldgroup, to conduct vital research.
On the 19th October, McCann Health in association with PMGroup, will look at the truth they uncover about health.
‘The Truth about Doctors’ the first study in the series, aims to get to the heart of the human under the white coat to better understand what motivates doctors and how we can improve the way we communicate to them.
The in vitro micronucleus assay is one of the most widely used tests to quantify genotoxicity and cytotoxicity, especially as a screening tool in the development of chemicals and pharmaceuticals. Micronuclei (MN) are formed from whole chromosomes or chromosome fragments that lag behind during the metaphase-anaphase transition and are excluded from the main nucleus following division. MN form into small, rounded bodies surrounded by their own nuclear envelope and represent chromosomal mutations that can be used as an endpoint in genotoxicity testing. Typically performed by manual microscopy, the MN assay is laborious and can be subject to scorer bias. To overcome this, automated microscopy and conventional flow cytometry methods have been developed. However, these methods suffer from several limitations such as the requirement to create high quality slides in the case of microscopy and the lack of visual confirmation of MN in the case of flow cytometry. The ImageStream®X (ISX) imaging flow cytometer has the potential to overcome these limitations as it combines the speed, statistical robustness and rare event capture capability of conventional flow cytometry with high resolution fluorescent imagery.
In this webinar, adaptation of the in vitro MN assay to an imaging flow cytometry-based method will be described. Using the ISX Mark II imaging flow cytometer, images of micronucleated mono- and binucleated cells as well as polynucleated cells can be captured at a high flow rate and automatically identified and scored in the Image Data Exploration and Analysis Software (IDEAS®) that accompanies the ISX. A data analysis template created specifically for this application allows for the determination of both genotoxicity and cytotoxicity following treatment with known clastogens and aneugens. This work is the first demonstration of fully automated method for performing the in vitro MN assay on an imaging flow cytometry platform.
Common mammalian cell lines used for biopharmaceutical production include Chinese Hamster Ovary (CHO), NS0 and Human Embryonic Kidney (HEK) cells. Each of these cell lines has been found with over 20,000 genes coded in their genome, which can result in over 10,000 proteins expressed at the same time in these cells. These proteins can be secreted from the living host cells or released to the cell culture supernatant upon lysis of the host cells during the cell culture. Biopharmaceuticals produced using these cell lines can be co-purified with a subset of the host-cell proteins (HCPs) in the cell culture supernatant.
These co-purified HCPs are considered process-related impurities for biopharmaceuticals. The HCPs can cause potential safety risks by introducing anti-HCP response in the patients. Depending on the biological functions of the residual HCPs, other potential impacts reported include lowering the biopharmaceutical protein stability and affecting the efficacy of the biopharmaceutical protein by exacerbating the symptoms.
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.
The Cancer Vanguard is a bold initiative setup to take leadership in the delivery of the National Cancer Strategy – Achieving World-Class Cancer Outcomes published in 2015 with a key aim of designing and implementing new and increasingly patient centric models of care in Cancer that can benefit and be adopted by the wider national cancer system.
In summer 2016 the Cancer Vanguard medicines optimisation team launched the ‘Pharma Challenge’ as an opportunity for the pharma and life sciences industry to identify innovative ways in which it could work in partnership with the NHS to improve the effective use of NHS resources, enhance the NHS’ understanding of the patient experience and make medicines optimisation part of routine practice. Four projects were taken forward including a partnership between the Cancer Vanguard, QuintilesIMS, Merck and uMotif,
This unique example of partnership working across the health system is focussed on the service at large, not just the pill, and uses leading edge data analytics to analyse, benchmark and visualise the current state of the cancer pathways within the Cancer Vanguard Trusts. Furthermore it encompasses multiple aspects of the service provision ranging from patient outcomes and experiences, the flow of treatment and the usage of medicine in order to inform an evidence based and patient centric approach to service redesign and resource optimisation.
Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges that do not require a stainless steel (SS) filter housing. This present article seeks to focus in particular on SU bioreactors for cell culture and bacterial fermentation for the purpose of producing therapeutic proteins, monoclonal antibodies and vaccines. SU bioreactors are of particular value in early phase (Clinical Phases 1 and 2) GMP manufacturing. In some cases their use has now stretched through into commercial processing, albeit that the scale of operation is currently limited and in general the largest commercially available SU bioreactors are around 2000L working volume (WV). However, the small footprint that they require, and the reduction in investment needed for support services and utilities, means that the scale limitations can be overcome to a significant degree by having multiple SU bioreactors operating in parallel within a facility. The harvest from multiple bioreactors can be pooled for downstream processing, or each harvest can be processed as a separate batch, based upon considerations of the risks versus the economies of pooling.
Recently, there has been a renewed interest in the field of continuous processing. Some key factors driving this interest are – availability of better cell retention devices, improved cell lines and culture medium capable of supporting high cell densities.
These factors have contributed mainly in reducing the batch duration for making the required quantity of product, thus reducing the medium requirement and chances of batch failures significantly. With the continuous processing being considered as ‘back-in-the-game’, the question remains: Can the current perfusion technology compete or replace the conventional and widely preferred fed-batch technology?
Two cases are discussed to compare the performance features of fed-batch and perfusion processes. In both the cases, the product output from perfusion process is significantly higher (2 to 5 folds) than that from fed-batch, due to combination of factors like higher cell density, higher cell specific productivity, lower accumulation of toxic metabolites etc. These cases demonstrate the potential of perfusion process in significantly increasing the product output. However, there are certain challenges and points to be considered before a company decides to switch to a perfusion platform. Some of these are highlighted in the article.
Multi-spectral imaging flow cytometry (MIFC) is an established analytical method for cellular analysis, however has only recently been evaluated for characterization of sub-visible particles in therapeutic formulations despite numerous favorable attributes including:
• Simultaneous collection of bright-field, side-scatter, and fluorescent imagery
• Sensitive detection of particles 100 nm-100 μm
• High image quality using 20X-60X magnification objectives
• 100% sampling efficiency using hydrodynamic focusing
• Small sample volume requirement (20 μL)
• Linear concentration range up to 100 million/mL
• Wide flow cell (250 μm) minimizes clogs
Assorted case studies using MIFC for analysis of protein and vaccine formulations will be presented, with an emphasis on measurements and samples that pose challenges for current techniques- including detection of small and transparent particles, direct analysis of highly concentrated formulations, and fluorescence characterization of particle type, chemical composition, and heterogeneous interactions.
Nearinfrared has a long tradition as analytical technology in pharmaceutical industry. In this article/webinar new applications, technology and improvements in regulatory guidances will be presented which will support further growth of nearinfrared in the pharmaceutical and biopharmaceutical industry.
Technical teams rely on the availability of meaningful data and effective tools to perform process monitoring, to conduct root cause analysis and investigations and, most of all, to obtain new insights into their operations. In this article, the authors discuss the implementation and management of a comprehensive system for data analytics at Shire –Lexington, MA site, the lessons learned, and practical advice towards the successful deployment of these key applications.
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.
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.
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.