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.
Mass spectrometry (MS) is an accepted research tool for both academic and industrial laboratories. As MS continues to gain ground in clinical and industrial testing, the requirements for high throughput, high sensitivity and high accuracy analyses put more emphasis on sample preparation. Solid Phase Microextraction (SPME) is well suited for this purpose as it requires minimal sample, provides pre-concentration of analytes, and allows for quantitative determinations.
This webinar will focus on the use of microextraction devices for direct MS analysis for applications that do not require chromatographic separation. Such analysis often results in very high throughput and more immediate results in comparison to traditional methods. Several Direct MS interfaces will be reviewed. The relevant overview of the literature as applied to the direct MS analysis of microextracted samples will be presented. The presentation also will discuss in more detail the coupling of Direct Analysis Real Time (DART) with a new type of solid phase microextraction devices (known as BioSPME).
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.
The development of human iPSC technology offers researchers the ability to more accurately generate physiologically relevant models of disease and normal tissues in the laboratory. Advances in iPSC generation have allowed many laboratories to make their own cell lines; however, researchers rarely have the resources needed to establish stocks, undertake quality control and share their own de novo iPSC cell lines with other laboratories. A pre-existing and established iPSC collection therefore allows iPSC researchers to obtain “off the shelf” access to a large, robust and reliable supply of iPS cell lines that represent diverse donor to donor variability and which include disease status normal controls and gene edited cell lines. iPSCs from ECACC are standardised and quality controlled and have the benefit of coming from a trusted and internationally recognised collection with worldwide distribution.
Over the past 10 years, Scopus has emerged as the partner of choice in the fast-developing field of rankings. Join us for a discussion on the importance of A&I data to ranking organizations, and why they choose Scopus.
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.
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.
In this special webinar, our guest presenter Samuel Constant Ph.D., Co-founder, CEO for OncoTheis will review:
- Novel in vitro tests for modelling lung cancer
- A model that allows long term monitoring of toxicity or efficacy on respiratory tract
- How OncoCilAir™ is a 3D human airway epithelium with tumors reconstituted in vitro
With more than 1 million deaths worldwide per year, lung cancer remains an area of unmet needs. Realistic human 3D models are required to improve preclinical predictivity. To that end, OncoTheis has engineered a novel in vitro lung cancer model, OncoCilAir™, which combines a functional reconstituted human airway epithelium, human lung fibroblasts and lung adenocarcinoma cell lines. Because of its unique lifespan (>3 month) and its dual composition (healthy and cancerous human tissues), OncoCilAir™ allows for the concurrent testing of the efficacy of drug candidates against malignant cells and their non-toxicity against healthy tissues. Accordingly, a first proof of concept study performed on a panel of anti-cancer drugs including the investigational drugs selumetinib and Mekinist® demonstrated that OncoCilAir™ carrying the KRASG12S mutation showed responsiveness in agreement with first clinical reported results, validating this unique tissue model as a predictive tool for anticancer drug efficacy evaluation. OncoTheis has now extended the model to EGFR mutations. Results showed that OncoCilAir™ EGFRdel19 is sensitive to Tarceva® and Iressa® treatments and provides a useful model to decipher in vitro mechanisms of resistance.
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.
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.
For more information on our Advanced Analytics offerings contact us at firstname.lastname@example.org and visit http://www.unisys.com/analytics
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.
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.
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).
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.
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.
In this on-demand webinar, Dr. Gert-Jan van de Geijn, renowned hematology expert, researcher and industry leader, discusses new chronic obstructive pulmonary disease (COPD) test parameters that better discriminate between bacterial and nonbacterial acute exacerbation. Dr. van de Geijn shares 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 viewing this 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
For more insight, watch a recorded Q&A session that followed the live webinar.
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.
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.
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.
¡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.
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.
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.
How can we create smarter, more effective communications for HCPs and patients? What can be done to challenge the status quo, apply a different mindset to communications, and deliver the best possible patient outcomes?
In this webinar, we will discuss how multichannel strategy and behavioural science are natural partners in creating smarter, more meaningful, and more effective communications. The premise is simple: if we apply a behavioural mindset, we can determine where to focus our communications for the best effect, design the most appropriate multichannel strategy and content, and put the right metrics in place to measure success.
Is your company a fully mature user of intelligence from social media, or is it still not tapping into insights?
As shown in the consumer world, social media can be a very rich source of insights into customers and markets, and can provide early signals of new trends. Exactly the same is true for patient and health care provider insights, especially when used with other more traditional data sets.
But understanding how to engage, and how to extract the right data to get actionable insights – and all the while complying with regulations – isn’t so straightforward.
Life sciences companies in particular, want to put this new data source in context with its already broad range of metrics. Achieving this calls for a step-by-step progression towards social media maturity.
pharmaphorum is working in collaboration with experts from IQVIA and Professor Andrew Stephen of Oxford University to deliver a topical debate focussed on this field, intended to provide answers to some of the conundrums the industry faces.
An expert panel will provide practical advice and real-life examples of how pharmaceutical companies can develop maturity in social media intelligence.
Increase your understanding of how social media can easily be used to ultimately add value
Learn the tricks - how, when and why marketers from other sectors use social media channels to their advantage
Hear how leading pharma organisations have embraced social media and have seen real results
Networks of influence are shifting the decision-making process for life sciences companies. It is no longer enough to simply view the profile of a HCP or HCO to understand their value to your organization.
For life sciences organizations, there is currently a gap in information, understanding, and digital access to these critical customer networks and relationships.
Relying solely on internal knowledge, field experience or purchased data provides an analog, one-dimensional view of these networks. This limits companies from fully understanding key influencers, referral pathways, speaker and authorship networks and more, which once uncovered can significantly influence customer outreach, messaging and engagement.
In this webinar, we’ll discuss how companies who embrace a holistic data and network analytics approach to strategic planning and execution can achieve significant competitive advantage, improved customer engagement and faster market penetration.
The healthcare landscape is rapidly changing as it responds to a multitude of well-known issues. Coupled with emerging digital technologies, these drivers are shaping the industry, moving it towards a more sophisticated, outcomes-driven model that demands a new approach. The new world emerging is one in which value is defined, created and evaluated in a very different way, with marketing playing a critical role.
On 30 November, EY (a global leader in assurance, tax, transaction and advisory services) in association with PMGroup, will host a free webinar debating the future of marketing in Life Sciences. Is your function fit for purpose?
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.
Change Together – www.changetogether.com – 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 collaboration and education. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.
The key topics our expert panel will be covering are:
– The power of collaboration
– Educating and communicating with physicians for better patient care
– Using social media and paid search to extend online engagement and reach
– Effecting health policy change at a federal and state level
The complexity and diversity of food matrices, and the need for clean extracts to be injected into analytical instrumentation may imply the use of tedious and time-consuming sample preparation strategies that often produce significant laboratory waste. The development of a new matrix-compatible solid phase microextraction (SPME) coating, namely PDMS/DVB/PDMS, bearing enhanced antifouling properties, enables the analysis of complex food matrices by direct immersion SPME, and helps to overcome issues related to extensive sample pre-treatment and instrumental contamination. This webinar will focus on recent advances made toward the analysis of contaminants in complex food samples by using the new matrix-compatible SPME coating, and will describe the optimization of important parameters to be considered when performing Direct Immersion SPME (DI-SPME).
Many Pharmacopeia materials contain water as hydrates or in adsorbed form. Therefore the determination of the water content is important to maintaining compliance with the Pharmacopeia guidelines. Generally one of the three methods are given in the monographs, Method I (Titrimetric), Method II (Azeotropic), or Method III (Gravimetric). This poster will discuss the application of these methods to moisture determinations focusing on Karl Fischer techniques.
In the continued effort to save you time and simplify your workflow, we’ve developed a Fontana-Masson Staining Kit with a protocol that is 30x faster than the standard protocol. In this webinar, the researcher who developed the kit explains how easy it is to use this new rapid microwave technique. If you need to stain melanin and argentaffin cells in tissue sections, take a few minutes to watch this webinar - and save yourself many more minutes in the future by using this kit.
Currently the US EPA has not promulgated a method for the analysis of Total Nitrogen (TN). Most states that have TN regulations require permitee's to measure TN as the composite of TKN, Nitrate and Nitrite. This approach is costly, time consuming, and also susceptible to variability based on the methods used for the individual analytes Merck, KGaA, Darmstadt, Germany is excited to announce the introduction of a Total Nitrogen Test Method consisting of a single spectrophotometric test kit. The method has been evaluated in a multilab study and this webinar will present the results of that study as well as an overview of the savings made possible by utilizing this new method for testing Total Nitrogen.
After 50 years of near-stagnation, pharmaceutical manufacturing is experiencing unprecedented scientific and technological innovation. There is a paradigm shift from testing product quality using lengthy off-line (and after-the-fact) assays to quality being tested during the process using online/ at-line measurements. This ability to evaluate and ensure quality of final product based on process data, geared towards making batch release decisions, is known as real time release testing (RTRt). A case study for predicting dissolution profiles of tablets made using CDC is presented. The methodology enables real-time release testing. Four different parameters were varied in the CDC line; API concentration, blender speed, feed frame speed, and compaction force, and their effect on tablet dissolution was investigated. Model dependent and model independent approaches were used to extract information from dissolution profiles. Multivariate regression was built between the information obtained from the NIR as the predictor variables and the dissolution profile parameters as the response. This enabled prediction of dissolution profiles for test samples made using CDC. Alternative RTRt approaches towards dissolution prediction will also be discussed.
Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Requirements and Study Design for Nonclinical Safety Evaluation
Nonclinical development of gene and cell therapies has been ongoing for more than three decades, and has been increasing in recent years. In the early days of these efforts, these therapies shared the fate of many novel experimental medicine approaches with progress impeded by severe side effects in treated patients or a failure to demonstrate efficacy in the target patient population. Research over the past decade has resulted in the development of highly sophisticated gene transfer tools with improved safety and therapeutic efficacy. As these tools have been developed, regulatory agencies worldwide have adapted new review processes and developed a wide range of guidance documents to aide researchers in designing rigorous nonclinical studies to ensure the safety, biodistribution and potential benefit of these advanced therapeutics. This presentation will provide an overview of the regulatory guidelines, provide some key considerations in the nonclinical development and testing of cellular and gene therapies, and detail several case studies of these therapeutics.
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.
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.
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.
The utilization of Multivariate Data Analysis (MVDA) techniques at Sanofi Pasteur, Toronto site has demonstrated innovative capabilities for improved process understanding, control and diagnostics. Examples from several successful and high impact applications will be presented. These examples cover the application of MVDA techniques in multivariate process control, root cause investigations and process analytical technology (PAT). The areas of application include fermentation, downstream purification and product formulation stages.
Continuous improvement, risk mitigation and adherence to compliance rely on the successful execution of key initiatives aligned with an organization’s strategic imperatives. This article summarizes the Project and Portfolio initiatives at Shire’s Biologics manufacturing facility at Shire, Lexington, MA site. In addition to practical advice, the authors discuss the need for sound business processes, alignment with Finance and budget cycles, and play special attention to the importance of resource allocation and management.
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.
The focus of this presentation is the application of Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Fluorimetry (DSF) methods to characterize vaccine components and their stability. Additionally, FTIR can be applied for the identification of final vaccine products, and DSF can be used to distinguish different formulations of vaccine candidates. These methods, when used in conjuction, provide valuable information regarding characterization and stability in the final stages of vaccine manufacturing.
The development of a suitable biologic formulation occurs often before analytical methods are validated. Certain chemical modifications are critical to monitor during the development process as they may cause protein instability and reduce biologic efficacy. Aspartic acid isomerization is one such modification, but is arguably the most difficult to detect. Analytical tools to track IsoAsp are discussed that can aid in making formulation decisions before the availability of qualified methods.
As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.