Get powerful life science insights from influential experts. Connect with thought leaders and colleagues to get the most up-to-date knowledge on strategies and initiatives to accelerate the transformation of U.S. and global health care from a volume- to value-based marketplace.
Lung cancer is the most commonly diagnosed non-skin cancer in the United States. Each year, over 222,000 people are diagnosed with lung cancer, and over 150,000 succumb each year to the illness, making it also the deadliest cancer in the country. With constant advancement of treatment options, the importance of accurate diagnosis and detection of lung cancer becomes more and more relevant to the survival of the patient. Immunohistochemistry has served as the catalyst for these advancements in lung cancer diagnosis. This presentation covers many of the basic science, facts, and statistics of lung cancer, as well as the utility of immunohistochemical testing with markers such as TTF-1, napsin A, desmoglein-3, and p40 in the accurate diagnosis and survival rates of lung cancer.
Growing patient influence combined with new technologies and the requirements of new reimbursement models means clinical research is undergoing rapid transformation. Industry is being compelled to move towards more patient centric solutions to keep up with these changes. With healthcare stakeholders in agreement that patient engagement is key to realising the value of clinical trials, regulators, sponsors, CROs, research funders and publishers are all moving towards more patient-focused models.
With the advent of new methodologies, such as electronic data sources and medical records, recruiting patients for trials now demands extensive collaboration between patients and trial centers to effectively and efficiently run trials. The patient has never been more important.
To mark Clinical Trials Awareness Week, pharmaphorum, in partnership with INC, will present a live webinar exploring the challenges and solutions of the current environment and how collaboration can benefit research participation, as well as the vital role the patient advocate plays in these matters.
In typical analytical workflows, sample preparation accounts for over 60% of the time taken to generate results and 30% of any errors generated. To help analytical chemists maintain the cornerstones of all analytical processes, namely; speed, specificity, sensitivity, and reproducibility, considerable resources have been devoted to the development of new and unique technologies in the sample preparation field. With specific reference to solid phase extraction and solid phase microextraction, this presentation will outline new technologies and techniques developed in sample preparation for food analysis.
The life sciences landscape is moving at a rapid pace, which in turn is increasing the demands on marketers to create innovative, digital content faster while maintaining industry compliance.
Veeva Systems recently conducted an annual industry study, focused on content and digital asset management within life sciences. Gleaned from the experiences and opinions of leaders across the life sciences industry, the research uncovers current practices and the industry’s need for more advanced approaches for global marketing and regulatory compliance.
Join this webinar to hear the key insights from the survey results, and discuss key highlights with host David Bennett, VP Commercial Content Strategy Europe, Veeva.
From this webinar you will:
– Learn the current state of commercial content and digital asset management in life sciences promotions
– Garner an understanding of how your organization compares to the industry
– Understand how to accelerate your content across the digital supply chain
Nearly 50% of business leaders fear they will become obsolete over the next several years, and nearly 80% feel threatened by digital startups. Why? New technologies and digital strategies are challenging existing business models and forcing companies of all sizes to reimagine patient care, product innovation and distribution models to remain competitive.
View this on-demand webinar hosted by PharmaVOICE to learn from Andrea Bradbury, Co-Founder and Chief Quality Officer, Suvoda Software, a leader operating at the intersection of life sciences and technology as she shares how she built her business on a digital platform to accelerate her organization’s global expansion while meeting the needs of mobile, digital customers and employees.
Topics covered include:
- Streamlining clinical research, sales and HR processes with digital tools
- Elevating the digital agenda at your organization
- Scaling technologies globally
- Applying nimble design models for life science operations
- Implementing top life sciences trends in 2017
Over the past few years there has been a shift in the European pharmaceutical market landscape, with a rise in specialty medicines for diseases with narrow patient populations. Indeed, QuintilesIMS forecasts that, between 2013 and 2018, 94% of list price value growth will be in specialty medicines – with orphan drugs at the forefront of this trend.
On 10 April 2017, QuintilesIMS, in partnership with pharmaphorum presents a unique digital debate, bringing together a panel of senior industry experts, including participants from NICE, NHS England and Genetic Alliance UK to explore the pillars of commercial success for orphan drugs in Europe in the context of changes in reimbursement processes and broader future challenges, like Brexit.
Chimeric antigen receptor (CAR)-T cells, which are engineered to recognize target cell surface antigens expressed on tumor cells, have shown promise to affect complete remission in patients with B-cell malignancies. However, applying this approach to target solid tumors has resulted in adverse effects in clinical studies. Methods for testing different models of CAR-T cells in vitro can provide further insight into viable antigen targets. Historically, two-dimensional (2D) cell culture models have been used in drug discovery. However, more elaborate, three-dimensional (3D) cell culture models better mimic the in vivo tumor microenvironment and help bridge the gap between in vitro studies and clinical outcomes.
In this special joint webinar, panelists from ProMab Biotechnologies, DiscoverX, and Corning Life Sciences will present data on a high-throughput, easy-to-use, highly reproducible method for screening CAR-T cells in a 3D cell culture model by combining various technologies.
Van Dang, D.V.M., Ph.D.
Scientist and coordinator for CAR-T research
ProMab Biotechnologies, Inc.
Abhi Saharia, Ph. D.
Director, Cell-based Assays and Biologics
Corning Life Sciences
Next-generation sequencing (NGS) technology has brought an influx of large-scale data and ever-growing demands for compute, resulting in a challenge for those in science informatics. To overcome these issues, laboratories need to be able to support researchers while managing data and the infrastructure needed to deliver mission-critical results and ultimately, positive patient outcomes.
At the NGS Data Analysis and Informatics Conference in February, attendees spoke about these challenges at length. This webinar, built from content shared at the event, will review potential approaches to cost-effective data growth using cloud compute and storage. Moving genomics workloads to the cloud can provide scale and affordability, while optimizing investments in existing resources. Adding that ability to allow researchers to easily collaborate while reducing latencies to these resources is pertinent to usability.
In this webinar, you’ll learn how to:
- Increase computation potential
- Optimize your physical infrastructure
- Diagram common use cases to meet specific research goals
- Increase flexibility by limiting data gravity
A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already licensed for use. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy.
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
This presentation will discuss NIHR Clinical Research Network support for Biosimilar clinical trials. It begins with a background to biosimilars and the changing landscape in their drug development and regulatory pathways. It then focuses on the opportunities that the NHS via the NIHR CRNs can engage in biosimilar clinical trials across therapeutic indications.
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.
Sponsored by Unchained Labs
Presentation Title: Limber up your lab with better tools for comparing biologics
There’s no magic bullet when it comes to characterizing a protein by structure or function. Specific tests may work for one molecule but not the next. Instrumentation that provides a high degree of flexibility, balanced with low sample consumption and faster time to result, is crucial to keep up with ever changing laboratory needs. Unchained Labs puts biologics characterization front and center for our instrumentation development. We will discuss how our instruments let researchers be more flexible and efficient, while also providing clear data to help make comparability assessments.
A new year, a new strategy, and new tools for winning sales! Join us for this webinar to get the inspiration and tips you need to set your intention to make 2017 the year of hustle, value creation, and digital transformation. Bestselling author and award-winning blogger, Anthony Iannarino, will share his top sales insights in this interactive webinar that welcomes audience participation and questions.
Key takeaways for this webinar will include
- The year of hustle. Learn how to create the right mindset and skillset to stay a step ahead of your competition.
- The year of value creation. Discover how top performers focus on value creation - Anthony will share his secret sauce for winning more sales.
- The year of digital transformation. Learn how to avoid time-wasting technology and social media traps and instead leverage the best tools to work 100 percent smarter, not harder.
Moderator: Gerhard Gschwandtner, Founder & CEO, Selling Power
Speakers: Anthony Iannarino, Bestselling Author and Sales Leader
Teja Vora, Director of Marketing, DocuSign
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.
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
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 our webinar, Identifying Men with Prostate Cancer—The Role of phi and Other Biomarkers, Dr. E. David Crawford will discuss key issues that challenge a physician's ability to make informed decisions regarding whom to biopsy for prostate cancer. After the webinar, you will be able to:
• Understand the historical perspective and controversy regarding prostate-specific antigen (PSA) screening
• Improve your interpretation of a PSA result
• Use biomarkers, such as Prostate Health Index (phi), to reduce negative biopsies and have more confidence in the decision to biopsy
• Understand how the phi score, combined with family and patient history, can determine patient management decisions
Dr. Crawford is an internationally renowned urologist and distinguished endowed professor of surgery, urology and radiation oncology. He also serves as the head of the section of urologic oncology at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. Dr. Crawford received his medical degree from the University of Cincinnati. His postgraduate training included an internship and residency in urology at the Good Samaritan Hospital in Cincinnati. He subsequently completed a genitourinary cancer fellowship at the University of California Medical Center in Los Angeles.
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.
According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies. As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist. This requires the pathologist to have a have a sound understanding of spermatogenesis, stage-aware evaluation of the testis, estrous and menstrual cyclicity, and normal physiology and endocrinology in order to carefully and thoroughly evaluate potential xenobiotic-related effects on the reproductive system. However, even with the most thorough pathology assessment, the design and conduct of nonclinical general toxicity studies can greatly impact the pathologist’s evaluation of the reproductive system. Commonly encountered challenges include age (onset of puberty and reproductive senescence), body weight changes and systemic toxicity, husbandry practices, strain differences, small sample size (non-rodents), and even histologic sectioning patterns.
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.
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
Are you having difficulty categorizing urine sediment particles due to operator subjectivity?
Automating urine sediment microscopy can help standardize particle characterization. In the final installment of our miniseries, Dr. Michael Samoszuk presents automated and manual microscopy study data from Dr. Sorin Gîju, clinical chemist at the Clinical Emergency Hospital in Timisoara, Romania.
Dr. Samoszuk compares results from the iRICELL3000 automated microscopy system and manual microscopy for the same patient samples. The iRICELL3000’s proprietary Digital Flow Morphology technology captures 500 images per sample and offers 12-particle classification, resulting in fewer opportunities to miss urine particles.
Watch this webinar to enhance your understanding of your urinalysis results.
Dr. Michael Samoszuk, M.D., vice president and chief medical officer of Beckman Coulter Diagnostics is a graduate of Harvard Medical School, Boston, and completed his postgraduate training at Brigham and Women's Hospital, Boston; University of California, San Francisco; and University of Southern California, Los Angeles. As an experienced chief medical officer, director of hemapathology and associate professor of pathology and radiology, Dr. Samoszuk contributes his expertise to Beckman Coulter’s diagnostics division. His guidance supports product and process developments as well as performance enhancements with patients and clinicians in mind.
Dr. Guido Vranken and 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 without 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.*
Presenters: Guido Vranken, Ph.D, 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.
Preclinical laboratories face several challenges when conducting animal studies requiring Biosafety Level (BSL) 2 level containment. Some of these challenges include informed study design (including knowledge of associated regulatory guidelines), proper preparation of the vivarium, species isolation, traffic control between containment areas, training of personnel, veterinarian care, and proper decontamination of equipment/waste/bedding prior to disposal. In addition, proper post-life handling of animals and samples, with focused attention on tissue sampling and specialized evaluation is a vital element in ensuring personnel safety and high scientific quality. Overcoming these hurdles will generate high quality data and allow for a safe and productive environment.
For the past two decades, Solid Phase Microextraction (SPME) has represented a convenient alternative to conventional sample prep procedures. SPME allows the simultaneous extraction and enrichment of analytes of interest from a given matrix in a single step while avoiding, or drastically minimizing, the use of organic solvents and time-consuming cleanup procedures.
Like any other analytical method, the various parameters governing the SPME process need to be carefully optimized in order to achieve robustness and sensitivity. However, certain aspects of SPME method development are often overlooked by many users, leading to unsatisfactory performance of the technique.
This webinar will shed light into several aspects of SPME method development. The presentation will include a theoretical explanation of SPME fundamentals and practical suggestions to overcome common errors and bias encountered when using SPME.
The webinar is divided in three main sections: 1) optimization of extraction conditions 2) matrix modifications 3) optimization of desorption conditions for gas and liquid chromatography. Each section is divided in various subsections dedicated to each parameter affecting the performance of the SPME technique. The webinar attendees will be guided through comprehensive understanding of the technology and the critical parameters that influence the extraction process with practical examples from already existing methods.
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.
SEND requirements are now in effect and many companies have implementation questions: Is SEND required for this study? What are the components of a complete SEND dataset package? What should be done with endpoints not modeled in SEND? This webinar will provide answers to those questions and provide best practices for determining how SEND requirements should be applied.
3D-printing has emerged as a very promising fabrication platform for complex tissue engineering. However, a significant limitation is the availability of biomaterial inks that can be 3D-printed into highly, biologically functional materials and structures. Join us as Professor Ramille Shah and Dr. Adam Jakus of the Shah TEAM Laboratory of The Shah Tissue Engineering and Additive Manufacturing (TEAM) Laboratory discuss their work to expand the current 3D-printable material toolbox. They will review not only the an extensive variety of tailorable, functional, and clinically friendly biomaterials and corresponding medical constructs, but also additional materials, such as metals, alloys, graphene, and ceramics.
Topics will include:
•Two new, distinct 3D-printable material platforms, Hydrogel Bioprinting and 3D-Painting, that have been developed and extended to create hundreds of distinct 3D-printable materials.
• The unique and advantageous properties of the new materials
• Specific examples of new 3D-printable material systems including, new hydrogels for liver, kidney, and ovarian tissue and organ engineering and 3D-painted Hyperelastic “Bone”, 3D-Graphene
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.
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.
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?
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 poor animal welfare program can derail your preclinical research. Join Chris Dillon as he examines the importance of animal welfare as it relates to drug development costs, compliance, and factors for considerations when outsourcing preclinical programs.
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
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.
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.
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.
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.