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.
A poor animal welfare program can derail your preclinical research. Join Chris Dillon as he examines the importance of animal welfare as it relates to drug development costs, compliance, and factors for considerations when outsourcing preclinical programs.
Does western blotting give you more trouble than expected? Do you feel like your precious samples are being wasted on bad westerns? Join us and find out how you can improve your western blots! In this seminar, you will learn general guidelines for performing and troubleshooting your westerns, such as:
• Choice of different blotting membranes
• Parameters affecting blotting efficiency
• Conditions for optimizing your immunodetection
• Information on SNAP i.d.® 2.0 system: A faster way to perform immunodetection
A digital debate analysing the future for biologics in the UK and the factor affecting market access in this territory. Our expert panel will cover a number of key topics including:
•Are the savings offered by biosimilars being used to innovate and take advantage of the exciting new biologic technologies or just filling in the NHS potholes?
•Will the industry continue to invest in cutting-edge research if the UK is not prepared to fund access to it
•In a post-Brexit world how can the UK continue to be a global leader at the cutting edge of biologics research?
Understanding the movements, modifications and interactions of proteins within a cell is key to unraveling the fundamental tenets of biology. However, the low-level expression of many proteins, combined with the transient nature of their interactions and movements, makes analyzing and understanding these processes quite difficult. Duolink® PLA, which is based on the principles of the proximity ligation assay (PLA), offers a solution to overcome these hurdles and to study the actions of endogenous proteins within cells and tissues. Combining the specificity of antibodies with the sensitivity afforded by rolling circle amplification, Duolink® PLA allows you to detect, visualize, and quantitate proteins and their interactions (even single events) where they happen within cells or tissue, all without overexpression or genetic manipulation. This seminar will cover the basic assay principle and advantages of the Duolink® PLA technology, and discuss recent applications and developments of the technology that make it an excellent tool to understand the fundamental mechanisms of biology, as well as disease states. Applications of Duolink® PLA include the investigation of cellular responses to varying stimuli, receptor dimerization and signalling cascades, post-translational modifications, and regulation of protein expression. New developments include use in flow cytometry and multiplexed detection.
Join SAS experts for this webinar and demo and learn how to take your workforce analytics from good to great. Learn how to put data-driven decisions within everyone’s reach when you empower your HR department with advanced (yet easy-to-use) SAS® analytics, BI and data visualization.
Market access is influencing drug development and commercial launch strategy more than ever before, with 85% of prescription drugs in the United States reimbursed through managed care plans. Biopharma companies must take into account a multitude of factors when considering physician prescribing behaviors, and need a more integrated "pull-through" strategy across their teams, from managed markets, to marketing, to field sales. Just as an engine needs a steady supply of fuel to run efficiently, prescriber-facing teams – the commercial engine of life sciences companies – need market access data and insights to accelerate brand success. Today, the challenge is optimizing this fuel supply, as market access and commercial teams often operate in a siloed way with regards to data, market changes and insights.
Join a vibrant conversation with industry leaders to discuss how the industry is changing and adapting to operationalize market access pull-through for improved commercial success.
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.
In this webinar, Eloísa Urrechaga, M.D., Ph.D., will discuss the importance of iron status assessment in accurately diagnosing and treating anemia. The complexities of anemia require solutions that will help meet the daily challenges of distinguishing iron deficiency anemia (IDA) and isolating anemia of chronic diseases (ACD) from the combined state of IDA/ACD.
After this webinar, you will be able to:
• Discuss current advancements in anemia diagnosis
• More clearly understand the role of accurate iron status assessment
• Cite the latest research experience with Beckman Coulter analyzers in assessing iron status
P.A.C.E. credit is available for your participation.*
Eloísa Urrechaga, M.D., Ph.D., has more than 30 years of experience in hematology and laboratory medicine. She is a specialist in clinical analysis technology, robotics in hematology, iron and anemia, erythropoiesis and glycohemoglobin. Currently, Dr. Urrechaga is responsible for the hematology laboratory at the Hospital Galdakao-Usansolo in Spain.
Dr. Urrechaga contributes her expertise to the Spanish Science and Innovation Ministry by assessing new technologies. She also provides counsel to the Health Research Council for the validation of research projects in the Czech Republic and Argentina. In addition, she is a member of several international organizations, such as the World Health Organization Guideline Development Group and European Network for Rare and Congenital Anaemias. Dr. Urrechaga also serves as an editorial board member and scientific reviewer for a number of journals.
*Beckman Coulter Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. These credits are recognized by the State of California. At this time, we cannot issue continuing education credits for those who provide healthcare (or work for an institution that provides healthcare) in Massachusetts or Vermont.
For the past two decades, Solid Phase Microextraction (SPME) has represented a convenient alternative to conventional sample prep procedures. SPME allows the simultaneous extraction and enrichment of analytes of interest from a given matrix in a single step while avoiding, or drastically minimizing, the use of organic solvents and time-consuming cleanup procedures.
Like any other analytical method, the various parameters governing the SPME process need to be carefully optimized in order to achieve robustness and sensitivity. However, certain aspects of SPME method development are often overlooked by many users, leading to unsatisfactory performance of the technique.
This webinar will shed light into several aspects of SPME method development. The presentation will include a theoretical explanation of SPME fundamentals and practical suggestions to overcome common errors and bias encountered when using SPME.
The webinar is divided in three main sections: 1) optimization of extraction conditions 2) matrix modifications 3) optimization of desorption conditions for gas and liquid chromatography. Each section is divided in various subsections dedicated to each parameter affecting the performance of the SPME technique. The webinar attendees will be guided through comprehensive understanding of the technology and the critical parameters that influence the extraction process with practical examples from already existing methods.
Lung cancer is the most commonly diagnosed non-skin cancer in the United States. Each year, over 222,000 people are diagnosed with lung cancer, and over 150,000 succumb each year to the illness, making it also the deadliest cancer in the country. With constant advancement of treatment options, the importance of accurate diagnosis and detection of lung cancer becomes more and more relevant to the survival of the patient. Immunohistochemistry has served as the catalyst for these advancements in lung cancer diagnosis. This presentation covers many of the basic science, facts, and statistics of lung cancer, as well as the utility of immunohistochemical testing with markers such as TTF-1, napsin A, desmoglein-3, and p40 in the accurate diagnosis and survival rates of lung cancer.
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
No matter how you feel about Edward Snowden, we could probably all agree that he played a significant role in bringing the privacy and security discussion to the Town Square. His actions have triggered a lot of discussions—within the U.S. government and outside, most notably with the tech industry and its citizens. But has anything changed? And how are things changing now that the United States is under a new administration?
Join Tamara Dull in this webcast as she highlights key events since Snowden’s revelations, where we’re at today, and what’s on the horizon as we move forward with the Trump administration.
About the Presenter:
Tamara Dull is the Director of Emerging Technologies for SAS Best Practices, a thought leadership team at SAS Institute. Through key industry engagements, and provocative articles and publications, she delivers a pragmatic perspective on big data, the Internet of Things, open source, privacy, and cybersecurity. Tamara began her high-tech journey long before the internet was born, and has held both technical and management positions for multiple technology vendors and consultancies, and a non-profit. She is listed in the IoT Institute's "25 Most Influential Women in IoT," as well as the "Big Data 2016: Top 100 Influencers and Brands" and "Top 100 Big Data Experts to Follow in 2016" lists.
Nearly 70 percent of business data contains some level of location information. But business analysts rarely use this data within their BI and analytics workflows.
Location analytics is more than just putting points on a map. It’s part of a much larger picture of using location to provide context in visualizations, reports and analytics. Utilizing geographic data in descriptive and predictive analytics helps companies discover new patterns, identify location-specific opportunities, and get a complete picture before making business decisions.
In this webinar, Esri and SAS discuss the role that location analytics can play in determining practical next steps for your organization. A product demonstration will be shown as well.
• How does location analytics add value to BI and analytics initiatives?
• What are the right uses for location analytics?
• What pitfalls should organizations consider as they implement processes and technology for analyzing geographic data?
• Are special skill sets required to use location information?
• How can organizations best develop a strategy for using geographic data?
With a wealth of market and regulatory changes impacting the medtech sector, it’s time for digital technology to steer the direction of your future business. This expert webinar will evaluate how to strategically embed digital within your own organisation and explore the challenges and the opportunities for transforming customer relationships, driving commercial outcomes.
– Respond to the changing regulatory environment: how technology empowers your business
– Build a business case for digital transformation and gain organisational support
– Strengthen your customer relationships and improve engagement in a diverse payer landscape
– Learn from pharma (and other industries) to find opportunities and avoid pitfalls
– Measure impact and return on investment from digital engagement
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
Solid phase microexatraction or SPME is a green method for extraction of analytes out of a sample. Since SPME is a non-exhaustive extraction technique, some analysts believe that SPME is not quantifiable. This presentation will provide basic information for developing a method to extract and quantify analytes using SPME. Examples will be given on the extraction and quantification of analytes out of various matrices, and SPME will be compared to other extraction techniques such as QuEChERS and SPE. In this webinar, we will discuss some new SPME technologies such as SPME-OC (over-coated) fibers and BioSPME that help to isolate and quantify analytes from interfering compounds in the matrix. Guidelines will be provided for enhancement of precision using SPME.
The kidney proximal tubule is the primary site of drug-induced nephrotoxicity. I will describe the development of a 3-dimensional flow-directed proximal tubule microphysiological system (MPS). The kidney MPS recapitulates the synthetic, metabolic and transport activities of kidney proximal tubule cells. This MPS is as an ideal platform for ex vivo modeling of nephrotoxicity. Towards this goal, we have evaluated nephrotoxicity in response to challenge with multiple toxicants, including the heavy metal pollutant cadmium, antisense oligonucleotides, the antibiotic polymyxin B and the Chinese herbal product aristolochic acid. We believe that MPS technologies will have major impacts on predictive toxicity testing and human risk assessment. Animal and in vitro systems do not always faithfully recapitulate drug and xenobiotic responses in the clinic or occupational/environmental exposures, respectively. MPS technologies will refine safety assessment and reduce our need for surrogate animal testing. An ultimate goal is to create integrated human MPS organ systems that could replace animal models.
Nortis has developed a technology that is used to recapitulate functional units of human organs in microfluidic devices (chips). Such organ models include vasculature, kidney, and liver models for toxicology studies, blood-brain barrier models for drug transport studies, and vascularized tumor microenvironment models for drug efficacy studies. These models exhibit in-vivo like barrier function, transporter polarity, and enzymatic activity. Common architecture to these and other tissue models in the Nortis system is a 5 mm long, 0.125-mm diameter lumen lined with endothelial or epithelial cells that is completely surrounded by a 3D extracellular matrix, usually collagen I, and is continuously perfused with nutrient medium. Co-culture of cells can be compartmentalized by seeding cells into the extracellular matrix prior to polymerization, thus representing tissue parenchyma, and cells seeded into the tubular void to form endothelial microvessels or epithelial tubules traversing the pseudo parenchyma. By applying growth factor gradients, endothelial microvessels can be coaxed into sprouting vascular networks that interact with cells embedded in the extracellular matrix, thus building vascularized microenvironments.
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.
Following a decade (or more) of concerted effort by industry, regulator, and academic groups, recent technology investments are now beginning to shape how medicines are being developed and manufactured for the global marketplace. While significant focus has highlighted the emergence of continuous manufacturing processes, three additional trends have also influenced and served as underlying drivers for these technology investments. First, the emergence of scientific advances in targeted biology has created high-value personalized medicines with smaller manufacturing volumes (doses/annum). Second, new regulatory pathways, such as the FDA’s Breakthrough Therapy designation, have accelerated the development and commercialization timelines for these new medicines. Finally, manufacturing localization has extended supply chain networks to serve globally-distributed patient populations throughout the world. Together, these drivers have served to shape the future of pharmaceutical development, manufacturing, and distribution of a variety of different dosage forms. The increasing need for product development speed and commercial supply flexibility through small-footprint, modular equipment trains will be highlighted within this paper, using an immediate-release solid oral dosage form example.
Common mammalian cell lines used for biopharmaceutical production include Chinese Hamster Ovary (CHO), NS0 and Human Embryonic Kidney (HEK) cells. Each of these cell lines has been found with over 20,000 genes coded in their genome, which can result in over 10,000 proteins expressed at the same time in these cells. These proteins can be secreted from the living host cells or released to the cell culture supernatant upon lysis of the host cells during the cell culture. Biopharmaceuticals produced using these cell lines can be co-purified with a subset of the host-cell proteins (HCPs) in the cell culture supernatant.
These co-purified HCPs are considered process-related impurities for biopharmaceuticals. The HCPs can cause potential safety risks by introducing anti-HCP response in the patients. Depending on the biological functions of the residual HCPs, other potential impacts reported include lowering the biopharmaceutical protein stability and affecting the efficacy of the biopharmaceutical protein by exacerbating the symptoms.
Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.
In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent.
Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.
This paper’s focus is on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.
Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges that do not require a stainless steel (SS) filter housing. This present article seeks to focus in particular on SU bioreactors for cell culture and bacterial fermentation for the purpose of producing therapeutic proteins, monoclonal antibodies and vaccines. SU bioreactors are of particular value in early phase (Clinical Phases 1 and 2) GMP manufacturing. In some cases their use has now stretched through into commercial processing, albeit that the scale of operation is currently limited and in general the largest commercially available SU bioreactors are around 2000L working volume (WV). However, the small footprint that they require, and the reduction in investment needed for support services and utilities, means that the scale limitations can be overcome to a significant degree by having multiple SU bioreactors operating in parallel within a facility. The harvest from multiple bioreactors can be pooled for downstream processing, or each harvest can be processed as a separate batch, based upon considerations of the risks versus the economies of pooling.
Recently, there has been a renewed interest in the field of continuous processing. Some key factors driving this interest are – availability of better cell retention devices, improved cell lines and culture medium capable of supporting high cell densities.
These factors have contributed mainly in reducing the batch duration for making the required quantity of product, thus reducing the medium requirement and chances of batch failures significantly. With the continuous processing being considered as ‘back-in-the-game’, the question remains: Can the current perfusion technology compete or replace the conventional and widely preferred fed-batch technology?
Two cases are discussed to compare the performance features of fed-batch and perfusion processes. In both the cases, the product output from perfusion process is significantly higher (2 to 5 folds) than that from fed-batch, due to combination of factors like higher cell density, higher cell specific productivity, lower accumulation of toxic metabolites etc. These cases demonstrate the potential of perfusion process in significantly increasing the product output. However, there are certain challenges and points to be considered before a company decides to switch to a perfusion platform. Some of these are highlighted in the article.
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.