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.
Chemical Patents are often very long and difficult to read. Markush searching can enable you to easily categorize and filter the information you need, giving you the insights that a paper sometimes cannot.
In this webinar you will learn:
-How to get started with patent search
-Basic patent language you need to be aware off
-How to create Markush searches to yield the best results when researching.
-Benefits of patent search for your processes
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.
Respiratory rate (RR) is a key physiological parameter that is used in a range of clinical settings for diagnosis and prognosis. Despite its importance, it is usually measured by hand. Over the past 50 years many techniques have been developed to estimate RR from two widely acquired physiological signals: the electrocardiogram (ECG) and the pulse oximetry signal (photoplethysmogram (PPG)). Although these techniques have been the subject of much research, they have not yet been widely integrated into clinical practice. This webinar will provide a comprehensive overview of the state of the art in estimating RR from the ECG and PPG. It is intended to equip researchers with the knowledge and tools to translate this promising technology into patient benefit.
Near-infrared 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.
Plan Explorer provides a new paradigm in treatment planning. This talk goes through the underlying algorithms, explains how to use the system, gives examples of plan configurations and provides an outlook into future developments of this feature found within the RayStation treatment planning software.
Clinical trial enrollment and site initiation is often hindered by cumbersome onboarding paperwork, delaying clinical research and R&D investments. The good news? Cedars-Sinai's Research Manager, Jenny Lester, and Associate Director, Therica Miller have solved the issue by going digital, leading to accelerated processes and greater compliance with regulations like 21 CFR Part 11.
Watch this on-demand webinar now and learn how to:
-Overcome challenges in clinical site initiation & maintenance
-Implement a pilot to test effectiveness of new digital processes
-Identify and activate use cases for digital investment
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.
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.
As medicines access evolves and pharmaceutical companies take an increasingly nuanced approach to it, it’s ever-more important to focus on particular aspects of this area and investigate whether firms are operating optimally.
To do this Inceptua Medicines Access and patient group, HAEi, in association with PMGroup, will host a free webinar on Thurday 14th December that will cover both the pre-approval access to medicines and the importance of putting patients at the heart of drug development and access.
Pre-approval access - a transformational approach
There are a number of factors at play within the world of medicines access: from industry who need to navigate requests for their pre-approval and unlicensed medicines, to healthcare professionals who are looking for options for their patients and ultimately to the patients and patient advocacy groups who are more empowered than ever and are driving for more timely access to treatments. Today’s healthcare, political and regulatory environments burden have generated a rapid, increasing and significant expansion in the need for access to these medicines. Mark Corbett, Executive Vice President at Inceptua Medicines Access talks about the company’s transformative approach to medicines access, designed to rise to the evolving challenges of the environment, offering unsurpassed understanding and insight into the needs of biopharmaceutical companies and healthcare organisations.
Patients at the heart of drug development and access
If you believe the news every day, patients are becoming more and more involved in drug development and access pathways, but what does this mean in reality
2018 will be a tipping point for mainstream adoption of popular digital health technology solutions such as artificial intelligence, mHealth/wearables, telehealth, Big Data analytics, and robotics. The transition of technologies from ideation to actionable applications will drive new opportunities across the globe.
From data monetization unleashing the power of patient data to digital transformation of patient monitoring, there will be growing awareness of current inefficiencies and new opportunities identified to improve the efficiency of healthcare delivery.
Maximise the impact of your published work! Find out more about sharing and promoting your research including SEO and Altmetrics.
You'll learn about:
-Title, Abstract and Keyword best practices
-Tips for building links
-Understanding Impact Factors and Altmetrics
-Tools and resources available to help you share and promote your work
Learn from and interact with the Editor-In-Chief for the Wiley Researcher Academy, Dr Andrew Moore. You’ll have the chance to ask questions during the live Q&A sessions and connect with other researchers in the BrightTalk community.
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.
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).
Publish with integrity! This webinar will explore strategies to ensure your scientific findings meet the necessary standards of transparency and reproducibility and achieve the highest impact within the scientific community. Experts in the field of neuroscience will provide targeted presentations followed by a Q&A.
Dr. Natalia Ortuzar is the Associate Editorial Director for Wiley-owned life and physical sciences journals in North America. Her team works on over 80 journals, covering topics from neuroscience and cell biology through to engineering and statistics. With a decade of publishing experience, Natalia has a background in open-access publishing and expertise in copyright and publishing ethics, as well as an intimate knowledge of the publishing process, from submission through peer review to production and post-publication, as an author, reviewer, and editor.
Dr. Prager is the Editor-in-Chief for the Journal of Neuroscience Research and the Developmental Editor for Current Protocols in Neuroscience and Current Protocols in Toxicology. Dr. Prager earned his Ph.D. from the Uniformed Services University in Neuroscience, where he investigated the long-term consequences of a nerve agent exposure. Cooperating with groups from the NIH and the National Centre for the Replacement, Refinement & Reduction of Animals in Research, Dr. Prager has developed new guidelines to promote transparent science and increase reproducibility of published research.
Biometrics has slowly become more and more present in our everyday lives. We no longer bat an eyelid when our phones require us to use a finger print for a payment or even when its how you get into your gym. So whats the next step?
Cubic, who are the people behind the payment technology of the London Transport System, have devised a system that can double the “throughput” of an entrance—from 25 people crossing a gate’s threshold per minute, to about 50 or 60. This idea could mean that we would no longer have gates at tube stations across London and instead your phone in combination with your face.
Niosha Kayhani of Cubic will be taking us through the development of this Technology and also the growing uses and industry that is Biometrics.
Generally speaking, physicists still find that computing with paper and pencil is in most cases simpler than computing with a Computer Algebra System (CAS). Although that is true in some cases, the working paradigm is changing: developments in CAS, and particularly recent ones in the Maple system, have resulted in the implementation of most of the mathematical objects and mathematics used in theoretical physics computations, and have dramatically approximated the notation used in the computer to the one used with paper and pencil, diminishing the learning gap and computer-syntax distraction to a strict minimum. In this talk, the Physics project at Maplesoft will be presented and the resulting Physics package will be illustrated through simple problems in classical field theory, quantum mechanics and general relativity, and through tackling the computations of some recent Physical Review papers in those areas.
The industry is being disrupted by integration of the multi-disciplinary capabilities in biology, chemistry and computational power that companies can leverage to develop new solutions to diagnose, treat and manage chronic disease conditions, such as cancer, cardiovascular disease and diabetes. There is immense pressure on companies to build competencies in product development, manufacturing and distribution of new technology platforms such as point-of-care molecular diagnostics to capture new growth opportunities in the precision medicine market—a paradigm shift that will transform clinical practice and treatment outcomes.
Join us for this very timely webinar with Dr Tristan Kershaw as he gives an overview of his book Climate Change Resilience in the Urban Environment. This new book is one of the first to look at the resilience of whole cities as the world’s population changes from 70% rural to 70% urban in the space of just 100 years. It looks at risks for urban areas, including those risks to human health as well as building integrity.
The webinar will last 45 minutes and will include a live Q&A session.
As a researcher do you ever have the following questions about peer review when looking to publish your research?
•Why is peer review important?
•How does the peer review process work?
•What does a reviewer look like?
•How does a journal editor use peer review?
Join us for our live webinar clinic and learn all you need to know about the role of peer review within the publishing process. Learn from and interact with the Editor-In-Chief for the Wiley Researcher Academy, Dr Andrew Moore. You’ll have the chance to ask questions during the live Q&A sessions and connect with other researchers in the BrightTalk community.
Are you interested in comprehensive coverage of all the major challenges facing you when publishing your scientific articles? This webinar will also include an introduction and overview of the Wiley Researcher Academy, a comprehensive, 50 hour training course covering all aspects of the publishing process as well as a detailed look at the skills and attributes of successful researchers.
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.
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?
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.
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
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.
Learn more about what happens once your research article submission has been accepted
•What are the author’s responsibilities?
•What do ethics in publishing looking like?
•What constitutes ethical misconduct?
•How do ethics support authors?
•What are the golden rules?
Join us for our live webinar clinic and learn all you need to know about publishing ethics, what they are, why they exist and how to successfully navigate through them.
Plus a chance to interact with the Editor-In-Chief for the Wiley Researcher Academy, Dr Andrew Moore and ask any further questions about the platform during the live Q&A sessions and connect with other researchers in the BrightTalk community.
Register for our FREE webinar now and you’ll receive guidance on:
•Ethics within scientific publishing
•Your roles and responsibilities
•What support and guidance tools are available
•Navigating ethical challenges
•The dos and don’ts of research publishing
The US medical imaging industry is transforming to cope with the challenges of the present and the demands of the future. The current care provision landscape is highly fragmented, and a coherent strategy is required to enhance interoperability among stakeholders across the imaging ecosystem. Stakeholders across the industry must also come together to eliminate redundancies and duplications, and streamline the imaging process, to improve the patient experience.
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.
Whether you are looking to perform gene overexpression studies or validate gene knockdown/knockout results from your RNAi/CRISPR experiments, LentiORFs are your ideal shortcut to protein expression and gene analysis. These genes are available in either pooled or arrayed libraries, and can also be combined into gene family sets and custom clone panels to meet diverse research needs. They are excellent reagents for gain-of-function screens and are a powerful complement to CRISPR and RNAi. In this webinar, we will introduce the LentiORF library and its various formats. We will discuss the application of this technology as it pertains to experimental design, delivery mechanisms, data analysis and target validation. Further, we will present recent data demonstrating clone representation of the library in each of its available formats, along with functional validation of the viral particles at the level of both viral integration and functional RNA expression.
Our ready-to-use Mission TRC3 LentiORFs allow for stable integration, enrichment of cells, and long-term gene expression in difficult-to-transfect cell lines utilizing our best-in-class lentiviral manufacturing. This collection provides researchers with unique tools to gain insights into gene function by modulating gene and protein expression.
For research data to be truly useful, it must be easy to access, share and manage without requiring expensive, custom infrastructure. What organizations need is turnkey storage that won't break the bank, with a unified interface for fast, reliable data transfer and sharing. This webinar introduces Globus for ActiveScale, a cost-effective solution for on-premise object storage that’s simple to deploy and use. With Globus for ActiveScale, researchers have access to advanced capabilities for managing data across a broad range of systems, while administrators gain a cost-effective, scalable, and durable solution they can deploy quickly to help their researchers innovate faster. In this webinar, attendees will learn how to deploy and use Globus for ActiveScale -- the session includes a product demonstration and a Q&A session with the Globus Chief Customer Officer.
Maximise the impact of your published work! Find out more about sharing and promoting your research including SEO and Altmetrics.
In the third and final webinar in our Learn to Publish series, our expert editors and marketers will cover:
-What you need to do to get read, get shared and get cited
-SEO in 4 easy steps
-Title, Abstract and Keyword best practices
-Tips for building links
-Understanding Impact Factors and Altmetrics
-Tools and resources available to help you share and promote your work
We’ll also be answering your questions in a live Q&A.
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.
Treating advanced-stage cervical cancer can be difficult without the right tools. Dr Matthew Biagioli will discuss a new option for reaching beyond the current constraints with the Venezia applicator for reproducible results and seamless integration into your current workflow.
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.
Many companies have influence in markets because they make essential products. Think about the products all around us the metals, plastics and various other materials that make up our world. We can see how a change in manufacturing processes or supply could influence the whole industry.
We are joined by Dr.Shafiq Kabir, Chief Innovation Officer at Smoltek AB, to learn how companies who rely on only Intellectual Property are working to change the market. Smoltek specialises in nanomaterials and their applications and brings together industry, intellectual property and manufacturers together.
This is essential viewing for anyone interested in nanomaterials/nanotechnology, IP, licensing and market penetration.
With the recent discovery of a special class of organic compounds with aggregation-induced emission (AIE) characteristics, new opportunities have opened for in vitro and in vivo imaging. In combination with advanced polymer encapsulation technologies, AIE compounds are now available as LuminiCell ultra-bright, organic nanoparticles that enable long-term cell tracking and imaging for applications such as cancer research and stem cell biology.
To help clarify the rapidly changing industry, Frost & Sullivan’s Digital Health experts invite you to join us for the webinar: Digital Health Predictions – Innovation, Opportunity & Challenges. Learn how to prepare for the future and gain insight into the hot topics you need to be aware of to drive your business forward into the next era of healthcare.
Expert Insights You Will Not Want to Miss:
• Hear Market predictions from world-renowned analysts
• Learn areas of growth and controversy for 2018
• Better understand the value of Artificial Intelligence
• Get answers on if mHealth is dead
• Learn more about crucial vendors to watch this year
If you want to learn how to simulate the thermoelectric effect in COMSOL Multiphysics® software, then tune into this webinar.
The thermoelectric effect, which involves the reversible conversion between heat and electricity, is a phenomenon that is used in both heating and cooling applications. The effect is often used in devices such as thermal sensors, energy harvesters and Peltier coolers.
In this webinar you will learn how to model the coupled phenomenon in COMSOL Multiphysics®. We will discuss the basic theory for heat transfer and electric currents as well as highlight how to account for the Peltier, Seebeck and Thomson effects. During a live demonstration these effects will be combined in a single model.
This webinar includes a Q&A session during which you can ask questions.
Technology transfer leading to a successful validation of a Monoclonal Antibody process at a CMO site is a complex task that would need seamless interaction between various functions of the sending and receiving organizations. The success of the process is very much dependent on the technical depth, personal trust and the strength of the relationships established between the team members across the various functions in both organizations. The interactions begin with the due diligence process and builds through laboratory scale technology transfer leading to engineering/GMP campaigns and ends with a successful validation. Depending on the stage in development of the molecule being technology transferred, the sending organizations could have personnel involved from both development and manufacturing making the process more complex. This write up will outline the role played by the various functions starting from Technical Services to Quality Assurance and will include functions like Shipping and Supply Chain.
Patent searching is something most IP counsel is very familiar with. It's your day to day when looking at Freedom to Operate, competitive analysis and portfolio management.
However, it can be hard to predict what you need in a search when you are not a technical expert. In this webinar, we will teach you how to construct the most effective searches using boolean and a few other tips and tricks on how to ensure you include all the technical detail you need.
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.
Time to Market is an essential metric that R&D teams are measured on. This becomes even more important when we are talking about patented chemicals and processes within the Medical, Pharma and Lifesciences.
If your competitor beats you to market all the time and money spent on research and development becomes a sunk cost, but how can data change that for you?
Using patent and journal data you can give your research teams the tools to quickly validate ideas and decide if they are worth pursuing and simultaneously remove the bottleneck that is placed on Data Analysts.
Join this webinar to learn how data can be applied to research and how this could cut costs and reduce time to market.
Engineered materials that integrate advances in polymer chemistry, nanotechnology, and biological sciences have the potential to create powerful medical therapies. Our group aims to engineer tissue regenerative therapies using water-containing polymer networks, called hydrogels, that can regulate cell behavior. Specifically, we have developed photocrosslinkable hybrid hydrogels that combine natural biomolecules with nanoparticles to regulate the chemical, biological, mechanical and electrical properties of gels. These functional scaffolds induce the differentiation of stem cells to desired cell types and direct the formation of vascularized heart or bone tissues. Since tissue function is highly dependent on architecture, we have also used microfabrication methods, such as microfluidics, photolithography, bioprinting, and molding, to regulate the architecture of these materials. We have employed these strategies to generate miniaturized tissues. To create tissue complexity, we have also developed directed assembly techniques to compile small tissue modules into larger constructs. It is anticipated that such approaches will lead to the development of next-generation regenerative therapeutics and biomedical devices.
This presentation will analyse the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence.
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.
This Webinar will review the current progress in the risk management of extractables and leachables (E&L) impurities with focus on protein therapeutics. While toxicology assessments of E&L impurities are maturing toward best practices, their potential impact to product quality requires new approaches from the toxicologist toolbox. This webinar will discuss the in silico prediction of chemical fictional groups that pose high risk of covalent binding, potentially leading to structural modifications of proteins and impact to quality attributes.