The medical research community on BrightTALK brings together medical and research professionals. Find relevant webinars on medical research, laboratory science, continuing medical education and more presented by recognized medical researchers. Join the conversation by participating in live webinars and round table discussions on the latest in medical devices, medical research practices and trends in the healthcare industry.
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.
Next-generation sequencing (NGS) has emerged as a key technology to deliver the next level of healthcare solutions. While the $1,000 genome was achieved in 2015, Frost & Sullivan predicts the $100 genome to be possible by 2024. The significant dip in cost of extracting genetic data has led to the creation of massive genomic data volumes that are expected to be some of the largest data sets globally by 2025, exceeding data generated by YouTube and Twitter.
During this webinar you will receive tips and tricks on:
•Understanding the principles of rotary evaporation
•Learning how to maximize output
•Finding out how to minimize contamination
•Handling different sample sizes and types
Hospital information technology (Hospital IT) spending in Asia-Pacific (APAC) will grow at a compound annual growth rate of 9.7% between 2016 and 2021 to reach an estimated end-stage market size of more than $15 billion. Key growth opportunities in the region include solutions for Healthcare Data Continuity, Patient Engagement & Experience, Healthcare Cloud, Big Data & Analytics, and Healthcare Cybersecurity. However, the identification of these growth opportunities is only the first step toward succeeding as an ICT vendor in this market. The real demystification lies in understanding very specific target customer needs and then building a value proposition and business model that addresses those needs.
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.
Join us to find out about the results of the 2017 Multichannel Maturometer. The ninth version of this industry-renowned survey illuminates some of the big changes sweeping through the Pharma industry, as well as highlighting some trends which are still lagging.
Questions which will be answered include:
• Is senior leadership still on the fence for digital?
• Marketing budgets – how are they changing?
• How satisfactory are those in the industry finding digital offerings?
The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.
Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.
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.
When new products approach the market the level of demand for them is often exaggerated.
However, in the real-world we know healthcare professionals may be less comfortable switching from a familiar product, even when clinical trial data suggests a newer product is superior. So what are we missing?
On the 11th July Cello Health Insight, in association with PMGroup, will host a free webinar where we will explore whether ‘regret minimisation’ - an alternative approach that focusses on minimising potential losses - has the potential to offer us new ways to understand the customer behaviour.
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
Immunotherapy is changing the cancer care paradigm: for a small but significant group of patients, cancer has become a chronic disease and immunotherapy biomarkers like PD-L1 play an important role. In this presentation, Professor Kerr will provide a summary of the immunotherapy treatment landscape, address what makes immunotherapy biomarkers unique compared to biomarkers like HER-2 and ALK, describe the function (physiologic and as a biomarker) of PD-L1 and other biomarkers relevant to the PD-1/PD-L1 pathway. He will also address the role of emerging immunotherapy biomarkers that are independent of the PD-1/PD-L1 pathway.
The ability to visualize immune responses non-invasively would have tremendous value for basic immunology. In pre-clinical models it would be possible to track events such as the host response to infections, to look at inflammation more generally, and to follow the course of interventions such as checkpoint blocking antibodies in the treatment of tumours.
PET imaging agents require a workflow compatible with the half-life of commonly used isotopes, and must take into account the pharmacokinetic properties of these agents. The specificity of what is being imaged requires the design of compounds that can distinguish between differences in metabolic activity (18F-fluorodeoxyglucose) or that serve as ligands for specific receptors, such as antibodies that recognize surface structures. We have used nanobodies, the smallest antibody-derived fragments that retain antigen-binding capacity. These fragments are ~15 kDa in size, are rapidly cleared from the circulation and are easily modified by chemo-enzymatic means for the installation of metal chelators or click handles to enable radiolabelling. Using nanobodies, we have been able to image various populations of immune cells, and based on longitudinal immuno-PET observations we have been able to make predictions of success and failure in immunotherapy of the B16 mouse melanoma model. The use of 89Zr-labelled nanobodies for immuno-PET will be a powerful adjunct to more conventional, invasive models, and will provide resolution superior to fluorescence- and luminescence-based models.
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.
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.
If you are interested in learning about photonics simulation using the COMSOL Multiphysics® software, then tune into this webinar.
Photonics (the generation, detection, and manipulation of light) plays a fundamental role in modern technology. It is used in a wide range of applications, such as telecommunications, medicine, computing, and manufacturing.
During this webinar, we will discuss using COMSOL Multiphysics® for photonics simulations, in particular periodic structures and crystals. We will show how modeling can provide insight into the design and characterisation of photonic devices. This includes solving for the propagation of electromagnetic waves, even in the presence of wavelength-dependent material properties, as well as multiphysics effects like heating or mechanical loading.
The webinar includes a live demonstration and a Q&A session during which you can ask questions.
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.
Innovation in chemistry is required in all sectors of industry, whether it be in pharmaceuticals, material science, or indeed any other branch of science. These innovations are the foundation of our modern society and lead the way for businesses to progress - and help the world to progress.
Chemical by PatSnap seamlessly links chemical structure searches to intellectual property data, enabling you to effortlessly discover chemical structures linked to the most relevant of patents, no matter how they’re described or written.
In this webinar, we’ll be joined by Chemist and IP expert Andy Lai as he demonstrates how you can validate your target chemicals performance against 114 million structures, from over 100 patent jurisdictions.
Some other topics that will be discussed include:
- How to utilize the similar search function to discover structures very close to yours
- How the Chemscape can highlight opportunities for licensing and collaboration
- Discover what the good chemical performance indicators look like
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.
Digital health brings a diverse range of growth opportunities for vendors across the value chain. As the space evolves we have experienced a multitude of stepwise successes and stellar failures, yet funding continues to flood the sector. Major moves continue to come into the industry from the broader vendor environment, underlining the importance of health in everyone’s lives and progressively in strategic interests of the C-Suite across the ecosystem. Join Frost & Sullivan in this webinar update showcasing different facets of the market, and learn why there’s something for everyone in digital health.
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
Wiley invites early career researchers to the second annual Wiley Humanities Festival!
Register today for Humanities Publishing 101 and join Wiley for a FREE webinar panel discussion from notable journal editors and scholars based around your needs as a researcher. You’ll hear advice on the best practices to getting published and discover the unspoken rules of publishing research in the Humanities.
Ann E. Larabee, Editor, The Journal of Popular Culture
Professor Michigan State University
20th-Century and Contemporary Literature
Dr. Willem B. Drees
Editor, Zygon: Journal of Religion & Science
Professor & Dean, Tilburg School of Humanities
Udo Schuklenk, PhD
Professor of Philosophy and Ontario Research Chair in Bioethics
Joint Editor-in-Chief Bioethics & Developing World Bioethics
Department of Philosophy
Associate Editorial Director, Social Sciences & Humanities,Wiley
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.
The advent of MRI-guided radiation therapy has introduced MRI’s powerful soft- tissue contrast into the treatment room, offering strong potential for improved targeting in many disease sites. In February 2017, ViewRay’s MRIdian linear accelerator (linac) received FDA clearance and the first patient treatment using MRIdian® Linac was conducted at Henry Ford Cancer Institute in July 2017. In this webinar, two key physicists involved in this project, Anthony Doemer, M.S., and Carri Glide-Hurst, Ph.D., will present their commissioning and clinical experience. Initial site planning, shielding, and MR safety considerations will be shared. The design aspects and functionality of the double-focused MLC, mechanical, and radiation characterization and validation will be presented. Commissioning of the MRI system, including novel aspects such as distortion assessment and field homogeneity in the presence of the linear accelerator will be highlighted. First clinical images and treatment plans will be shared to highlight the first months of clinical operation.
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.
The recent global hacks on companies and organisations including Merck, Mondolez International, Rosneft and the NHS have demonstrated that all different types of industries are at risk when it comes to cyber attacks/hacks.
Most people think about the obvious affects such as consumer data infringement or loss of functionality but what can an attack mean for your R&D department?
Jeff Middleton, CEO of Lantium, who build bespoke cyber security solutions, will take us through the learning's of recent "Petya" and "WannaCry" attacks, as well as how we can prevent and minimise losses in such instances.
Topics covered in this webinar:
- Recent Global Attacks and learning
- How Cyber attacks affect R&D, M&A and IP
- What to consider when creating a cyber-safety strategy.
Essential viewing for anyone that runs a company where data could be at risk.
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.
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.
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.
The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity of immunogens (toxoids, conjugate and subunit vaccines, live-attenuated and inactivated viruses, VLPs, etc.), and the variety of unique processes currently utilized to produce either single- or multi-component vaccines, it is unlikely that the transition to continuous processing will happen overnight. Additionally, cultural challenges are faced whenever a new mode of operation appears to some as “too different”, especially in a traditionally conservative sector like the developed-world vaccine industry. That said, market forces, global climate change, and Nature’s propensity to fill unoccupied niches with emerging infectious diseases will undoubtedly induce a first round of pioneers to explore this exciting new design space, ultimately leading to a more nimble industry and more and better opportunities for protection for the global population.