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.
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?
Understanding the movements, modifications and interactions of proteins within a cell is key to unraveling the fundamental tenets of biology. However, the low-level expression of many proteins, combined with the transient nature of their interactions and movements, makes analyzing and understanding these processes quite difficult. Duolink® PLA, which is based on the principles of the proximity ligation assay (PLA), offers a solution to overcome these hurdles and to study the actions of endogenous proteins within cells and tissues. Combining the specificity of antibodies with the sensitivity afforded by rolling circle amplification, Duolink® PLA allows you to detect, visualize, and quantitate proteins and their interactions (even single events) where they happen within cells or tissue, all without overexpression or genetic manipulation. This seminar will cover the basic assay principle and advantages of the Duolink® PLA technology, and discuss recent applications and developments of the technology that make it an excellent tool to understand the fundamental mechanisms of biology, as well as disease states. Applications of Duolink® PLA include the investigation of cellular responses to varying stimuli, receptor dimerization and signalling cascades, post-translational modifications, and regulation of protein expression. New developments include use in flow cytometry and multiplexed detection.
Join SAS experts for this webinar and demo and learn how to take your workforce analytics from good to great. Learn how to put data-driven decisions within everyone’s reach when you empower your HR department with advanced (yet easy-to-use) SAS® analytics, BI and data visualization.
Market access is influencing drug development and commercial launch strategy more than ever before, with 85% of prescription drugs in the United States reimbursed through managed care plans. Biopharma companies must take into account a multitude of factors when considering physician prescribing behaviors, and need a more integrated "pull-through" strategy across their teams, from managed markets, to marketing, to field sales. Just as an engine needs a steady supply of fuel to run efficiently, prescriber-facing teams – the commercial engine of life sciences companies – need market access data and insights to accelerate brand success. Today, the challenge is optimizing this fuel supply, as market access and commercial teams often operate in a siloed way with regards to data, market changes and insights.
Join a vibrant conversation with industry leaders to discuss how the industry is changing and adapting to operationalize market access pull-through for improved commercial success.
In this webinar, Eloísa Urrechaga, M.D., Ph.D., will discuss the importance of iron status assessment in accurately diagnosing and treating anemia. The complexities of anemia require solutions that will help meet the daily challenges of distinguishing iron deficiency anemia (IDA) and isolating anemia of chronic diseases (ACD) from the combined state of IDA/ACD.
After this webinar, you will be able to:
• Discuss current advancements in anemia diagnosis
• More clearly understand the role of accurate iron status assessment
• Cite the latest research experience with Beckman Coulter analyzers in assessing iron status
P.A.C.E. credit is available for your participation.*
Eloísa Urrechaga, M.D., Ph.D., has more than 30 years of experience in hematology and laboratory medicine. She is a specialist in clinical analysis technology, robotics in hematology, iron and anemia, erythropoiesis and glycohemoglobin. Currently, Dr. Urrechaga is responsible for the hematology laboratory at the Hospital Galdakao-Usansolo in Spain.
Dr. Urrechaga contributes her expertise to the Spanish Science and Innovation Ministry by assessing new technologies. She also provides counsel to the Health Research Council for the validation of research projects in the Czech Republic and Argentina. In addition, she is a member of several international organizations, such as the World Health Organization Guideline Development Group and European Network for Rare and Congenital Anaemias. Dr. Urrechaga also serves as an editorial board member and scientific reviewer for a number of journals.
*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.
SEND requirements are now in effect and many companies have implementation questions: Is SEND required for this study? What are the components of a complete SEND dataset package? What should be done with endpoints not modeled in SEND? This webinar will provide answers to those questions and provide best practices for determining how SEND requirements should be applied.
For the past two decades, Solid Phase Microextraction (SPME) has represented a convenient alternative to conventional sample prep procedures. SPME allows the simultaneous extraction and enrichment of analytes of interest from a given matrix in a single step while avoiding, or drastically minimizing, the use of organic solvents and time-consuming cleanup procedures.
Like any other analytical method, the various parameters governing the SPME process need to be carefully optimized in order to achieve robustness and sensitivity. However, certain aspects of SPME method development are often overlooked by many users, leading to unsatisfactory performance of the technique.
This webinar will shed light into several aspects of SPME method development. The presentation will include a theoretical explanation of SPME fundamentals and practical suggestions to overcome common errors and bias encountered when using SPME.
The webinar is divided in three main sections: 1) optimization of extraction conditions 2) matrix modifications 3) optimization of desorption conditions for gas and liquid chromatography. Each section is divided in various subsections dedicated to each parameter affecting the performance of the SPME technique. The webinar attendees will be guided through comprehensive understanding of the technology and the critical parameters that influence the extraction process with practical examples from already existing methods.
Lung cancer is the most commonly diagnosed non-skin cancer in the United States. Each year, over 222,000 people are diagnosed with lung cancer, and over 150,000 succumb each year to the illness, making it also the deadliest cancer in the country. With constant advancement of treatment options, the importance of accurate diagnosis and detection of lung cancer becomes more and more relevant to the survival of the patient. Immunohistochemistry has served as the catalyst for these advancements in lung cancer diagnosis. This presentation covers many of the basic science, facts, and statistics of lung cancer, as well as the utility of immunohistochemical testing with markers such as TTF-1, napsin A, desmoglein-3, and p40 in the accurate diagnosis and survival rates of lung cancer.
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.
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
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.
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
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!
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.
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.
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 Speaker: 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.
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.
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.
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.
Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.
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.
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.
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 article 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.
Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.