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.
3D culture is gaining pivotal importance for attaining in vivo-like conditions in a dish to study developmental cues as well as therapeutic possibilities. Organoid development promises to be one of the most important research tools in the near future. This presentation will cover:
• Methodologies used in organoid culture
• Matrices for growing organoids
• Recovery of organoids for downstream applications
Dr. Nitin Kulkarni is a member of the Scientific Support team at Corning Life Sciences. He has a Ph.D. in Biology and has worked on engineering transgenic mouse models for autoimmune diseases during his post-doctoral research at the Beth Israel Deaconess Medical Center in Boston, MA.
In his current role, he supports researchers with applications related to cell culture including advanced surfaces and extracellular matrices, genomics, drug discovery and bioprocesses.
Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are:
1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and
In the fourth of our series of webinars showcasing presentations from the PMB 60th Anniversary Symposium, Katia Parodi examines the key ingredients of modern adaptive radiotherapy, including fast computational models and methods for in-vivo dose/range assessment. She also takes a look forward to the era of biological guidance.
Almost all clinics, small and large, use magnetic resonance images (MRI) in their treatment-planning workflows. Modern treatment planning requires images of high geometric fidelity with high spatial and contrast resolution to delineate disease extent and proximity to adjacent organs at risk. However, imaging protocols needed for accurate treatment planning differ significantly from those used in diagnostic radiology. As the integration of MRI into radiation oncology is expanding rapidly, a need exists to highlight the considerations for safe and effective implementation. This webinar will describe the major differences from diagnostic MRI, provide an overview of MRI safety and training models, introduce clinical-workflow considerations, and describe the development of a robust quality-assurance programme. Special considerations for motion management and treatment planning will be described.
Sourcing for the manufacture and control of Antibody-Drug Conjugates (ADCs) used in clinical trials requires strategic planning, establishment of a specialized support network, and execution of several interdependent tasks. ADCs are complex molecules, a fusion of a biological, the monoclonal antibody (mAb), and of small molecules, the linker and the toxic payload. Facilities of acceptable standards for the handling of high potency materials need to be engaged, and there is a limited supply currently. This is further complicated by the fact that there is not one contract facility that has fully integrated services, a “one-stop shop” capable of mAb production, linker and/or payload synthesis, conjugation of mAb to linker-payload to make the Drug Substance, and finally, formulation of the ADC to make the Drug Product. Strategizing the best outsourcing practices for producing and testing ADCs, and establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer, will be further discussed.
Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a range of opportunity and challenges, including the use of Process Analytical Technology (PAT) for process characterization, process control, and process robustness, in support of a Rapid Product Release (RPR) strategy.
Three-dimensional cell cultures, and multicellular tumor spheroids in (MCTS) in particular, have recently become a widely used tool for preclinical anticancer drug testing in high-throughput screening (HTS) setup. However, even though MCTS have been applied for HTS, their use has been limited to simple assays, such as assessing cell viability or inhibition of growth.
This webinar will cover new approaches to MCTS-based HTS. It will present a new, robust viability assay, well-suited for HTS and based on green fluorescent protein (GFP) used as a surrogate marker of spheroid viability. It will also review a first-ever approach to obtain information-rich transcriptomic data from drug-treated MCTS on a large scale. In addition, the presenter will demonstrate how this novel platform resulted in the identification of previously unrecognized, context-dependent drug responses of cancer cells and in findings with potential clinical relevance.
In summary, this webinar will demonstrate new ways of how MCTS-based HTS can be used to provide unique insights into context-dependent biology and cellular drug responses.
About the Presenter:
Wojciech Senkowski will soon complete his Ph.D. in Medical Sciences at Uppsala University, Sweden. In his work, he looks for applications of various tumor spheroid models in high throughput drug screening. For his work, Wojciech has received the AACR Scholar-in-Training Award. He was also a presenter and expert panelist at the Genetic Engineering & Biotechnology News webinar on 3D cell cultures, sponsored by Corning in February of 2016.
Over the past decade, the adoption of digital solutions has increased significantly throughout the healthcare industry. This exceptionally strong growth trajectory is expected to continue into the foreseeable future as U.S. healthcare organizations transform to meet the demand for more efficient, clinically integrated and decentralized care systems that serve empowered, technologically-savvy consumers who strongly value convenience and personalization.
This webinar will take a look at the various ways in which you can utilize the plethora of tools in the PatSnap armory to make sure you’re up to date on your competitors, suppliers, and even your own portfolio.
Whether it’s making sure you know about the new patents that have been filed, or the new markets that have been identified, we can help ensure you’re not behind on the news.
This webinar will focus on best practices when licensing out intellectual property to avoid any potential litigation risks later on. Owen will be discussing a variety of ways in which you can construct a licensing agreement and techniques to ensure both sides get a good deal.
This session is presented by Owen Nicholson, Head of Growth at IN-PART. Owen was previously Operations Manager for the Dyson Robotics Lab and External Research Programme Manager for Dyson
The healthcare industry is undergoing rapid transformation. By 2025, the healthcare ecosystem is expected to look drastically different from today. In 2025, global trends of aging populations, rising chronic disease prevalence and urbanization are bound to further strain healthcare systems already grappling with issues of healthcare access, quality, and cost. In response, new business models are expected to emerge to address the needs of the future. In order to make the most gains, stakeholders must successfully leverage this transformation.
Everyone in pharma is talking about patient centricity, but how is the drive received ‘on the ground’ among patients who are its focus? How is it unfolding and how far is it being implemented? Do patients even notice it is happening?
On the 24 January, Cello Health Insight in association with PMGroup, will host a free webinar which will look to unravel the multi-faceted issue of patient centricity from the patient perspective.
What does it really mean for patients and how are they befitting from the initiative? What can market research contribute to our understanding of the current state of play of patient centricity?
It is time to take stock and ask ourselves whether the patient-focused activities are benefiting patients and influencing R&D or are they simply a marketing initiative.
Optical devices are key components in many areas, such as communications, remote sensing and medical applications, and their role will increase in the future. Simulations are already a very efficient way of optimizing a device, even before the prototype stage. However, simulating optical devices needs distinct consideration due to the special material models, such as graphene, or simply due to the size of the device in relation to the wavelengths of interest.
CST STUDIO SUITE® offers a unique platform for handling such challenges. The user may import or build even highly complex structures using a user-friendly, interactive GUI. The photonic/plasmonic behaviour of the device can then be simulated by selecting the most appropriate algorithm (e.g. FIT/FDTD, FEM, BEM/MoM, MLFMM and more). Dispersive, anisotropic and nonlinear materials are supported. High-performance computing (HPC) options, such as MPI or GPU, are available, and the results can be displayed and analysed in the GUI using a comprehensive post-processing library and state-of-the-art visualization engine.
In addition, CST STUDIO SUITE® includes multiphysics solvers linked to EM, allowing users to, for example, simulate the effect of thermal tuning.
This webinar will demonstrate how CST STUDIO SUITE can be used to analyse a number of essential optical devices, such as silicon-on-insulator (SOI) waveguide components, photonic crystals (PC), plasmonic devices and optical gratings.
Join us for an interactive webinar with Dylan O. Adams, a Senior Patent Attorney and Amazon Bestselling Author of "Patents Demystified: An Insider's Guide to Protecting Ideas and Inventions."
His book, Patents Demystified, is the Official Patent Guide of The American Bar Association and is used at Top Universities Including Harvard and Stanford. As a senior patent attorney, Dylan has experience with U.S. and foreign patents in a wide variety of technology fields, including software, computer hardware and biotechnology.
In this webinar, we will explore which patent protection strategy best fits your business goals, both short and long-term. We will discuss best practices on how to work with your patent attorneys to craft the strategy that fits current and future budget constraints, and how you can easily leverage your patent assets and derive the most value from them.
Welcome to PatSnap. In this initial onboarding webinar, emphasis will be put on understanding the core aspects of intellectual property and applying this to the fundamental tools and features within our system.
You’ll leave these sessions understanding how to:
•Perform basic searches on PatSnap, using IPC’s and boolean operators
• How to filter your search results to ensure only the most relevant patents appear
• Customising your account settings
• Identify individual sections of a patent document, (patent families, citation analysis etc...)
• Utilise your research efforts by saving and sharing your work, building basic lists, or downloading full patent documents.
Join us as we discuss CiteScore metrics - the free, transparent, comprehensive, and current metrics now available as part of the Scopus basket of metrics.
Here are some of the topics you can expect to learn about:
-The Scopus basket of metrics
-Why have CiteScore metrics been added to the basket?
-What are CiteScore metrics?
-How can CiteScore metrics be accessed?
-How you can get involved in defining the basket of metrics
In this webinar, Dr. Michael Samoszuk will discuss the correlation between images of urine sediment particles captured on the iRICELL3000 and images viewed manually under the microscope using actual patient samples. Attendees will learn how these images compare and how automated microscopy helps to reduce user subjectivity in microscopy by standardizing the process.
Join Laura Schoppe, President of Fuentek, a consulting firm specializing in IP asset management, tech transfer and commercialization - on Wednesday 11th January to find out how you can improve the ROI of your intellectual property by using patent data.
In this session, you will learn how to get early market feedback, and develop new commercial opportunities for your IP. Laura will provide practical, actionable advice on:
- Readiness Assessment for Market Planning (RAMP)
- Identifying potential collaborators and licensees
- Verifying market fit and collecting feedback
- Developing a licensing / commercialization strategy for your IP
There will also be time for a live Q&A, so if you have any questions about commercializing your IP, this is a great opportunity to speak to an expert.
What does the Apple vs Samsung SCOTUS ruling mean for the patent industry in 2017?
Gene Quinn and special guests look back at the most important moments of 2016, and consider the issues that look set to shape the patent industry in 2017
It is that time once again when we look back on the previous year in preparation to close the final chapter on 2016, and we begin to look ahead and ask what is in store for the new year.
Gene Quinn, patent attorney and founder of IPWatchdog.com, will moderate this discussion, alongside a panel of very special guests.
Join us as we discuss:
2016: The Year of the Patent Trial and Appeal Board – From the Supreme Court deciding Cuozzo, to the Federal Circuit spending much of the year rubber stamping the PTAB, it has been a rollercoaster year.
2016: Software Patents Strike Back – A series of Federal Circuit decisions post-Alice have started to provide meaningful insight into how software can be described so that it will be considered patent eligible.
2017: Regulatory Reform NOT Patent Reform – Patent reform will almost certainly not be a top priority for the Trump Administration, but regulatory reforms to the PTAB could be seen and may be quite significant and beneficial to patent owners.
2017: Supreme Court to Decide Samsung v. Apple - The decision will either validate the value of design patents or make design patents virtually worthless.
In this webinar, Dr. Guido Vranken and product manager Lobke Tremmerie discuss how to implement Bulls XB algorithm, which uses RBC indices to create a weighted moving average of patient sample results, to statistically monitor hematology results. This unique algorithm, offered on Beckman Coulter hematology instruments, allows users to monitor result quality with no additional reagents, software licenses or costs. Laboratories worldwide can implement this simple, powerful tool to enhance results and improve compliance. P.A.C.E. credit is available for your participation.*
Dr. Guido Vranken has been working with customers for over 30 years across different disciplines, including protein chemistry, immunoassay and hematology. He specializes in conducting internal and external validation studies. Dr. Vranken spent three years as a lecturer on statistics at the University of Ghent.
Lobke Tremmerie earned her environmental engineering degree from the University of Ghent in 2002. She first became an electrophoresis and nephelometry sales engineer at Analis, Beckman Coulter’s exclusive Belgian distributor. Following her true passion, she transferred into the hematology division in 2004. Ms. Tremmerie currently serves as Analis’ cellular biology product marketing manager.
The atomic force microscope (AFM) has played an essential role in 2D materials research since it was used to confirm the first isolation of graphene. Today’s AFMs are even more powerful, with higher spatial resolution, faster imaging rates, greater environmental control and enhanced modes for mapping physical properties. They can image crystal lattice structure as well as nanoscale morphology, and sense local electrical, mechanical and functional response in more ways than ever before.
In this webinar we explore the latest AFM tools that enable higher resolution, sensitivity and more quantitative results for analysing 2D materials. We’ll present results from measurements of a variety of 2D materials for device manufacturing, energy storage and optoelectronics including:
• MoS2 and graphene;
• measurements of mechanical properties;
• kelvin probe imaging (KPFM) of operating transistors;
• electromechanical measurements.
Finally, we discuss how AFM can now be used to accurately determine the thickness of single or multiple layers of a 2D material. This will challenge the misconception that AFM cannot be used to precisely measure the thickness of 2D materials.
Resource constraints, financial and human, mean that most universities simply do not have the luxury of being able to back every research commercialisation opportunity. Therefore, it is essential to develop a strategy and process that optimises the chances of backing winners, be it to maximise the financial return or to address the non-financial impact agenda.
PatSnap will be teaming up Isis Enterprise, the innovation consultancy division of Oxford University Innovation, to discuss some key measures that can be taken to identify promising commercialisation projects that are underpinned by strong intellectual property. We will also be providing insight on methods for trimming and shaping academic patent portfolios so that they are optimised for strong overall returns.
In the third of our webinars showcasing presentations from the PMB 60th Anniversary Symposium, Bas Raaymakers examines the use of image guidance during radiation therapy. He will describe the various options available for radiotherapy guidance, including in-room CT-on-rails, MV imaging, fluoroscopy, ultrasound, tracking of implanted beacons and cone-beam CT. In particular, he will discuss the use of MRI for real-time visualization of the tumour and its surroundings during treatment.
With rising healthcare costs, more informed and engaged patients, and advancing technology, health wearables have seen a significant uptake in recent years. However, the full potential of health wearables has yet to be recognised and there are still challenges to be resolved. What needs to be done on the regulatory, technical and healthcare side to take health wearables to the next level?
In this webinar, experts from the life sciences and technology industries discuss their views on the current state and future developments of health wearables, including:
– The user perspective: perception, adoption and expectations today and tomorrow
– The technology perspective: biggest successes and most room for improvements
– The societal and regulatory perspective: cost and risks versus benefits and opportunities
In this webinar, Dr. Michael Samoszuk discusses the correlative relationships between urine chemistry analytes and the particles noted under the microscope. Attendees will learn how using the knowledge of these correlations can optimize parameter setting for improved laboratory workflow.
The physics of electromagnetic coupling through space is fundamental to modern technology. It is exploited in some devices such as RFID tags and directional couplers to communicate information. In other devices, electromagnetic interference (EMI) is an unwanted effect that must be controlled: for example, the problem of crosstalk in electrical circuits and cables. In this webinar we will discuss the simulation of electromagnetic coupling in a variety of different applications, considering examples of capacitive, inductive and radiative couplings in frequencies from the kHz to GHz range. We will show how modelling can provide insight into design, either to improve the quality of a communication device, or to mitigate EMI through effective electromagnetic shielding. A live demo will illustrate how to simulate antenna crosstalk using COMSOL Multiphysics®. We will conclude this webinar with a Q&A session.
Discover what successful researchers do to get published!
Do you need advice on finding the right journal? Does peer review feel like a mystery? Do you want tips on how to maximize the impact of your research? Do you want to connect with our experienced editors in real-time? …well this is the webinar for you!
In this practical webinar you'll hear expert publishing advice from Katy Dillon, Associate Journals Editor for the Journal of the Science of Food and Agriculture, Anne Nijs, Deputy Editor, European Journal of Organic Chemistry and Vicky Kinsman, Wiley Author Services. Register for your place today and learn all you need to know to start feeling confident about publishing your next research paper.
The in vitro diagnostics industry is shifting because of 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 improve 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. This will transform clinical practice and treatment outcomes.
2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region. There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic protocols and and details of negotiations with drug manufacturers. We also see member states working to understand the process of enabling cost-effective patient access to personalised and high-cost treatments, such as new oncology combination therapies, antibiotics and stem cell therapies, which offer the promise of efficacy in key disease areas.
With market access being referred to as the “fourth hurdle” in drug development (beyond efficacy, safety and quality), it is vital that the requirements for both approval and access are addressed early in the process. Parallel scientific advice from HTA bodies and regulators is increasing to deliver tangible and successful strategies, but is the process smooth enough to overcome the challenges from both sides?
pharmaphorum in partnership with DIA will be hosting an expert panel debating the best way forward for life sciences companies, payers and providers in this emerging European market access paradigm.
Join our webinar to hear from experts in industry and healthcare discussing the challenges and solutions of access in the changing European market.
Topics up for discussion include:
•Integrating HTA and regulatory strategy – the best way forward
•Regional variation and implication – how to efficiently and effectively navigate EU market access
•Proving value – how to leverage real world evidence to meet increasing demands for observational data
•Future proofing market access – how to improve upon evidence generation and use technology effectively and competitively
The use of calibrators in an analytical method is important to ensure measurement accuracy and traceability and instrument reliability. The major challenges with testosterone testing by LC-MS/MS typically involve achieving consistency in performance and accuracy of results at low levels found in women and children across different laboratories. This lecture presents the new CE marked testosterone serum calibrator kit for in-vitro diagnostic (IVD) from Merck KGAa Darmstadt, Germany . It is for use in LC-MS/MS testosterone testing methods. Mr. Johnson will highlight the unique features and benefits of this regulatory cleared Certified Reference Material as a calibrant for standardization of laboratory LC-MS/MS testosterone methods.
In this webinar, Elena Lazarova, M.D., esteemed clinical biology specialist, researcher and speaker, will discuss the value of precise cell volume measurement in differentiating for blood disorders and its importance in effective patient care. Gaining information about cell volume at different stages in the maturation process provides important insight into a patient’s underlying pathology and may have added value in the diagnosis of blood disorders. Beckman Coulter offers precise cell volume measurement* through the advanced technology and sophisticated algorithms of its uniquely designed DxH 800 hematology systems.
After the webinar, you will be able to:
• Cite the challenges laboratories face in differentiating for rare types of anemia
• Outline the benefits of flow cytometric reticulocyte analysis, available on the DxH 800 platform
• Understand the value of precise cellular volume measurement* to aid in the differential diagnosis of anemia
*For research use only and not cleared by the FDA for clinical diagnosis
**P.A.C.E. credit is available for your participation.
Dr. Elena Lazarova earned her M.D. degree from the Medical University of Varna, Bulgaria, in 2002. With over 10 years of experience in clinical and laboratory hematology, immunohematology and transfusion medicine, Dr. Lazarova is a highly sought-after teacher and lecturer. She has authored/co-authored seven medical journal articles and has served as primary author on 17 poster and oral presentations at congresses throughout the world. Dr. Lazarova continues her work in laboratory medicine, focusing on hemoglobinopathies and red blood cell pathologies (hereditary spherocytosis and autoimmune hemolytic anemia) in laboratories at Hôpital Erasme in Brussels.
CRISPR Cas9 nucleases have revolutionized the field of gene editing and high-throughput lentiviral screens continue to hold ever-increasing promise for both basic research and development of future therapies to benefit human health. Even with such powerful technologies at hand, researchers new to the field may find the screening of multiple targets to be challenging and time-consuming. This webinar discusses the Evotec partnership with Life Science Business of Merck KGaA, Darmstadt, Germany and the screening services for drug discovery.
In the fifth and final of our series of webinars showcasing presentations from the PMB 60th Anniversary Symposium, Robert Jeraj from the University of Wisconsin takes a look at what may lie ahead for medical physics in the next 60 years.
Dr Lisa Haile presents this webinar exploring issues and strategies for diagnostic and therapeutic patents and licenses.
This webinar will address questions such as:
Are diagnostic tests patentable?
What are the effects of the Alice ruling and the Myriad Genetics case on patents?
What strategies can be used to avoid the pitfalls associated with patenting around "laws of nature"?
What are the latest rulings and precedents around diagnostics and genetic markers and how is the landscape evolving?
This is essential viewing for anyone involved with intellectual property and innovation in the life sciences sector.
Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.
Pharmacists are highly trained healthcare professionals who have a deep understanding of medicines and daily contact with patients and consumers. This puts them in a unique position in terms of being able to maximise the benefits that patients get from their medicines – however, healthcare systems and pharmaceutical companies frequently overlook this potential.
Pharmacists are especially well placed to help patients with multiple long-term conditions manage their health and medications, and pharmacist-led interventions have been shown to have a very significant impact on compliance and disease management in the community.
We present a webinar debate in which our expert panel will discuss how pharmaceutical companies can work in collaboration with pharmacists in Europe to help patients make the most of their medicines, help generate data to prove the value of these interventions, and above all get the right medicine to the right patients and consumers.
Join us and the PHOENIX group as we look at the practical steps needed to make this a reality. Key topics to be discussed include:
•The challenges of identifying the right patient population across European markets
•Understanding how pharmacists can play a greater role in patient care, e.g. improved adherence and outcomes
•How optimum use of pharmacy level information can contribute to providing ‘real world’ evidence of treatments
The use of calibrators in an analytical method is important to ensure measurement accuracy and traceability and instrument reliability. The major challenges with testosterone testing by LC-MS/MS typically involve achieving consistency in performance and accuracy of results at low levels found in women and children across different laboratories. This lecture presents the new CE marked testosterone serum calibrator kit for in-vitro diagnostic (IVD) from Merck KGaA, Darmstadt, Germany . It is for use in LC-MS/MS testosterone testing methods. Dr. Hardt will highlight the unique features and benefits of this regulatory cleared Certified Reference Material as a calibrant for standardization of laboratory LC-MS/MS testosterone methods.
Join us for the March CDx Insights webinar “Large B-Cell Lymphomas: WHO 2016 Classification Update and Predictive Biomarkers.” Our speaker is Yaso Natkunam, MD, PhD, Professor of Pathology and Director of Hematopathology at Stanford University School of Medicine. Dr Natkunam will review key updates to the classifications of large B-cell lymphomas in the “2016 revision of the World Health Organization classification of lymphoid neoplasms.” She will also discuss the role of diagnostic and predictive biomarkers in DLBCL, high grade B-cell lymphoma and other large B-cell lymphomas.
The increased interest and adoption of single use systems (SUS) or disposables require that organizations rethink their operational business processes and the design and configuration of manufacturing execution systems (MES). Drawing from their previous experience implementing MES and SUS for biologics manufacturing, the authors discuss the key areas of impact of SUS on operational technology, outline new user requirements, and propose practical solutions for successful MES implementation.
TeVido BioDevices uses the innovative process of 3D bioprinting living human cells for use as implants or grafts for use in reconstructive surgery and wound care, for example in post-surgery care for cancer patients.
TeVido uses a simple yet sophisticated approach to produce living tissue products - inkjet printers modified to print cells instead of ink.
In this live webinar, Dr. Scott Collins, CTO and VP of Research and Development at TeVido, will explain TeVido’s innovation journey, from concept, through research and prototying, to funding, patenting, and testing the company’s highly innovative offering in the field of biotechnology.
Single-Use Process Analytical Technologies (PAT) tools have a great potential to not only increase process understanding at the seed stage but also simplify cell culture operations. By utilizing PAT, the risk from bioburden or contamination can be significantly reduced and the overall operating efficiency increased. In fact, PAT also provides a data-driven platform to integrate Process Development and Manufacturing Operations that can mitigate risks associated with technology/process transfer.
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.
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.
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.