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.
Chemical Patents are often very long and difficult to read. Markush searching can enable you to easily categorize and filter the information you need, giving you the insights that a paper sometimes cannot.
In this webinar you will learn:
-How to get started with patent search
-Basic patent language you need to be aware off
-How to create Markush searches to yield the best results when researching.
-Benefits of patent search for your processes
Technical teams rely on the availability of meaningful data and effective tools to perform process monitoring, to conduct root cause analysis and investigations and, most of all, to obtain new insights into their operations. In this article, the authors discuss the implementation and management of a comprehensive system for data analytics at Shire –Lexington, MA site, the lessons learned, and practical advice towards the successful deployment of these key applications.
Near-infrared has a long tradition as analytical technology in pharmaceutical industry. In this article/webinar new applications, technology and improvements in regulatory guidances will be presented which will support further growth of nearinfrared in the pharmaceutical and biopharmaceutical industry.
Today’s government and commercial health care market is in a constant state of change. Both government agencies and private insurers need to bring value through more effective claims, clinical targeting and revenue optimization. And payers are looking for single-source system that delivers an innovative, broad spectrum of services to fill gaps in their existing processes and improve outcomes.
During this session we’ll look at a payment integrity approach that delivers results. We’ll also share case studies to show how you can use analytics to create measurable financial impact for both government and commercial payers and providers.
We’ll review four key disciplines, including:
Clinical trial enrollment and site initiation is often hindered by cumbersome onboarding paperwork, delaying clinical research and R&D investments. The good news? Cedars-Sinai's Research Manager, Jenny Lester, and Associate Director, Therica Miller have solved the issue by going digital, leading to accelerated processes and greater compliance with regulations like 21 CFR Part 11.
Watch this on-demand webinar now and learn how to:
-Overcome challenges in clinical site initiation & maintenance
-Implement a pilot to test effectiveness of new digital processes
-Identify and activate use cases for digital investment
Currently the US EPA has not promulgated a method for the analysis of Total Nitrogen (TN). Most states that have TN regulations require permitee's to measure TN as the composite of TKN, Nitrate and Nitrite. This approach is costly, time consuming, and also susceptible to variability based on the methods used for the individual analytes Merck, KGaA, Darmstadt, Germany is excited to announce the introduction of a Total Nitrogen Test Method consisting of a single spectrophotometric test kit. The method has been evaluated in a multilab study and this webinar will present the results of that study as well as an overview of the savings made possible by utilizing this new method for testing Total Nitrogen.
In the continued effort to save you time and simplify your workflow, we’ve developed a Fontana-Masson Staining Kit with a protocol that is 30x faster than the standard protocol. In this webinar, the researcher who developed the kit explains how easy it is to use this new rapid microwave technique. If you need to stain melanin and argentaffin cells in tissue sections, take a few minutes to watch this webinar - and save yourself many more minutes in the future by using this kit.
Many Pharmacopeia materials contain water as hydrates or in adsorbed form. Therefore the determination of the water content is important to maintaining compliance with the Pharmacopeia guidelines. Generally one of the three methods are given in the monographs, Method I (Titrimetric), Method II (Azeotropic), or Method III (Gravimetric). This poster will discuss the application of these methods to moisture determinations focusing on Karl Fischer techniques.
The complexity and diversity of food matrices, and the need for clean extracts to be injected into analytical instrumentation may imply the use of tedious and time-consuming sample preparation strategies that often produce significant laboratory waste. The development of a new matrix-compatible solid phase microextraction (SPME) coating, namely PDMS/DVB/PDMS, bearing enhanced antifouling properties, enables the analysis of complex food matrices by direct immersion SPME, and helps to overcome issues related to extensive sample pre-treatment and instrumental contamination. This webinar will focus on recent advances made toward the analysis of contaminants in complex food samples by using the new matrix-compatible SPME coating, and will describe the optimization of important parameters to be considered when performing Direct Immersion SPME (DI-SPME).
Biometrics has slowly become more and more present in our everyday lives. We no longer bat an eyelid when our phones require us to use a finger print for a payment or even when its how you get into your gym. So whats the next step?
Cubic, who are the people behind the payment technology of the London Transport System, have devised a system that can double the “throughput” of an entrance—from 25 people crossing a gate’s threshold per minute, to about 50 or 60. This idea could mean that we would no longer have gates at tube stations across London and instead your phone in combination with your face.
Niosha Kayhani of Cubic will be taking us through the development of this Technology and also the growing uses and industry that is Biometrics.
Change Together – www.changetogether.com – will be presenting a live webinar with leading figures from the patient advocacy community, who will debate how we can drive positive change for patients through collaboration and education. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.
The key topics our expert panel will be covering are:
– The power of collaboration
– Educating and communicating with physicians for better patient care
– Using social media and paid search to extend online engagement and reach
– Effecting health policy change at a federal and state level
Multi-spectral imaging flow cytometry (MIFC) is an established analytical method for cellular analysis, however has only recently been evaluated for characterization of sub-visible particles in therapeutic formulations despite numerous favorable attributes including:
• Simultaneous collection of bright-field, side-scatter, and fluorescent imagery
• Sensitive detection of particles 100 nm-100 μm
• High image quality using 20X-60X magnification objectives
• 100% sampling efficiency using hydrodynamic focusing
• Small sample volume requirement (20 μL)
• Linear concentration range up to 100 million/mL
• Wide flow cell (250 μm) minimizes clogs
Assorted case studies using MIFC for analysis of protein and vaccine formulations will be presented, with an emphasis on measurements and samples that pose challenges for current techniques- including detection of small and transparent particles, direct analysis of highly concentrated formulations, and fluorescence characterization of particle type, chemical composition, and heterogeneous interactions.
The healthcare landscape is rapidly changing as it responds to a multitude of well-known issues. Coupled with emerging digital technologies, these drivers are shaping the industry, moving it towards a more sophisticated, outcomes-driven model that demands a new approach. The new world emerging is one in which value is defined, created and evaluated in a very different way, with marketing playing a critical role.
On 30 November, EY (a global leader in assurance, tax, transaction and advisory services) in association with PMGroup, will host a free webinar debating the future of marketing in Life Sciences. Is your function fit for purpose?
Networks of influence are shifting the decision-making process for life sciences companies. It is no longer enough to simply view the profile of a HCP or HCO to understand their value to your organization.
For life sciences organizations, there is currently a gap in information, understanding, and digital access to these critical customer networks and relationships.
Relying solely on internal knowledge, field experience or purchased data provides an analog, one-dimensional view of these networks. This limits companies from fully understanding key influencers, referral pathways, speaker and authorship networks and more, which once uncovered can significantly influence customer outreach, messaging and engagement.
In this webinar, we’ll discuss how companies who embrace a holistic data and network analytics approach to strategic planning and execution can achieve significant competitive advantage, improved customer engagement and faster market penetration.
Is your company a fully mature user of intelligence from social media, or is it still not tapping into insights?
As shown in the consumer world, social media can be a very rich source of insights into customers and markets, and can provide early signals of new trends. Exactly the same is true for patient and health care provider insights, especially when used with other more traditional data sets.
But understanding how to engage, and how to extract the right data to get actionable insights – and all the while complying with regulations – isn’t so straightforward.
Life sciences companies in particular, want to put this new data source in context with its already broad range of metrics. Achieving this calls for a step-by-step progression towards social media maturity.
pharmaphorum is working in collaboration with experts from IQVIA and Professor Andrew Stephen of Oxford University to deliver a topical debate focussed on this field, intended to provide answers to some of the conundrums the industry faces.
An expert panel will provide practical advice and real-life examples of how pharmaceutical companies can develop maturity in social media intelligence.
Increase your understanding of how social media can easily be used to ultimately add value
Learn the tricks - how, when and why marketers from other sectors use social media channels to their advantage
Hear how leading pharma organisations have embraced social media and have seen real results
How can we create smarter, more effective communications for HCPs and patients? What can be done to challenge the status quo, apply a different mindset to communications, and deliver the best possible patient outcomes?
In this webinar, we will discuss how multichannel strategy and behavioural science are natural partners in creating smarter, more meaningful, and more effective communications. The premise is simple: if we apply a behavioural mindset, we can determine where to focus our communications for the best effect, design the most appropriate multichannel strategy and content, and put the right metrics in place to measure success.
Mass spectrometry (MS) is an accepted research tool for both academic and industrial laboratories. As MS continues to gain ground in clinical and industrial testing, the requirements for high throughput, high sensitivity and high accuracy analyses put more emphasis on sample preparation. Solid Phase Microextraction (SPME) is well suited for this purpose as it requires minimal sample, provides pre-concentration of analytes, and allows for quantitative determinations.
This webinar will focus on the use of microextraction devices for direct MS analysis for applications that do not require chromatographic separation. Such analysis often results in very high throughput and more immediate results in comparison to traditional methods. Several Direct MS interfaces will be reviewed. The relevant overview of the literature as applied to the direct MS analysis of microextracted samples will be presented. The presentation also will discuss in more detail the coupling of Direct Analysis Real Time (DART) with a new type of solid phase microextraction devices (known as BioSPME).
Hear Jack Montgomery share his experiences and methodologies in applying sigma analysis to lab quality control at Asante Health, a Truven Health Analytics Top 100 hospital the past four years.
In this webinar, Jack will discuss the dynamic nature of sigma metrics for clinical chemistry analytes. He will show how they can be improved over time with enhanced monitoring and optimized maintenance schedules. This sensitivity of sigma metrics highlights the notion that sigma methodology is just one of the many tools that should be used for a holistic approach to lab quality.
By attending this webinar, you will:
- Understand the practical use of Six Sigma as a lab quality tool
- Learn about the dynamic nature of sigma metrics and how they can be improved in the lab
- Gain insights into the additional tools for implementing a multi-faceted total quality program
P.A.C.E. credit is available for your participation.*
Jack Montgomery, MLS(ASCP)cm, is the chemistry technical specialist for Rogue Regional Medical Center—the flagship entity for Asante Health—a growing three-hospital system located in southern Oregon containing a laboratory accredited by the College of American Pathologists. Jack has over 40 years of experience in the clinical laboratory with a special interest in quality control, sigma metrics and method validation.
*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. Most programs also provide State of Florida credits (with valid license number). 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.
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 of human iPSC technology offers researchers the ability to more accurately generate physiologically relevant models of disease and normal tissues in the laboratory. Advances in iPSC generation have allowed many laboratories to make their own cell lines; however, researchers rarely have the resources needed to establish stocks, undertake quality control and share their own de novo iPSC cell lines with other laboratories. A pre-existing and established iPSC collection therefore allows iPSC researchers to obtain “off the shelf” access to a large, robust and reliable supply of iPS cell lines that represent diverse donor to donor variability and which include disease status normal controls and gene edited cell lines. iPSCs from ECACC are standardised and quality controlled and have the benefit of coming from a trusted and internationally recognised collection with worldwide distribution.
Over the past 10 years, Scopus has emerged as the partner of choice in the fast-developing field of rankings. Join us for a discussion on the importance of A&I data to ranking organizations, and why they choose Scopus.
David Pridham, Chief Executive Officer and Brad Sheafe, Chief Intellectual Property Officer of Dominion Harbor will be taking us through their recent acquisition of the Kodak Patent Portfolio and the steps they are taking to monetise over 4000 patents.
Unfortunately patent monetisation isn't as simple as selling or licensing, it depends heavily on the other players in the market, where the market is moving and also the litigation and future legislation when it comes to that particular technology.
This webinar will cover:
- The analytical approach (using technology to help assess the opportunity)
- The go-to-market strategy development
- How to present this strategy to potential buyers without being exposed to litigation risks
- Building global partnerships to maximise the monetisation potential of the portfolio in a heterogeneous, world-wide marketplace
- Managing prosecution, maintenance, divestiture and abandonment
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.
The Cancer Vanguard is a bold initiative setup to take leadership in the delivery of the National Cancer Strategy – Achieving World-Class Cancer Outcomes published in 2015 with a key aim of designing and implementing new and increasingly patient centric models of care in Cancer that can benefit and be adopted by the wider national cancer system.
In summer 2016 the Cancer Vanguard medicines optimisation team launched the ‘Pharma Challenge’ as an opportunity for the pharma and life sciences industry to identify innovative ways in which it could work in partnership with the NHS to improve the effective use of NHS resources, enhance the NHS’ understanding of the patient experience and make medicines optimisation part of routine practice. Four projects were taken forward including a partnership between the Cancer Vanguard, QuintilesIMS, Merck and uMotif,
This unique example of partnership working across the health system is focussed on the service at large, not just the pill, and uses leading edge data analytics to analyse, benchmark and visualise the current state of the cancer pathways within the Cancer Vanguard Trusts. Furthermore it encompasses multiple aspects of the service provision ranging from patient outcomes and experiences, the flow of treatment and the usage of medicine in order to inform an evidence based and patient centric approach to service redesign and resource optimisation.
Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Requirements and Study Design for Nonclinical Safety Evaluation
Nonclinical development of gene and cell therapies has been ongoing for more than three decades, and has been increasing in recent years. In the early days of these efforts, these therapies shared the fate of many novel experimental medicine approaches with progress impeded by severe side effects in treated patients or a failure to demonstrate efficacy in the target patient population. Research over the past decade has resulted in the development of highly sophisticated gene transfer tools with improved safety and therapeutic efficacy. As these tools have been developed, regulatory agencies worldwide have adapted new review processes and developed a wide range of guidance documents to aide researchers in designing rigorous nonclinical studies to ensure the safety, biodistribution and potential benefit of these advanced therapeutics. This presentation will provide an overview of the regulatory guidelines, provide some key considerations in the nonclinical development and testing of cellular and gene therapies, and detail several case studies of these therapeutics.
Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.
In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent.
Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.
This paper’s focus is on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.
Whether you are looking to perform gene overexpression studies or validate gene knockdown/knockout results from your RNAi/CRISPR experiments, LentiORFs are your ideal shortcut to protein expression and gene analysis. These genes are available in either pooled or arrayed libraries, and can also be combined into gene family sets and custom clone panels to meet diverse research needs. They are excellent reagents for gain-of-function screens and are a powerful complement to CRISPR and RNAi. In this webinar, we will introduce the LentiORF library and its various formats. We will discuss the application of this technology as it pertains to experimental design, delivery mechanisms, data analysis and target validation. Further, we will present recent data demonstrating clone representation of the library in each of its available formats, along with functional validation of the viral particles at the level of both viral integration and functional RNA expression.
Our ready-to-use Mission TRC3 LentiORFs allow for stable integration, enrichment of cells, and long-term gene expression in difficult-to-transfect cell lines utilizing our best-in-class lentiviral manufacturing. This collection provides researchers with unique tools to gain insights into gene function by modulating gene and protein expression.
For research data to be truly useful, it must be easy to access, share and manage without requiring expensive, custom infrastructure. What organizations need is turnkey storage that won't break the bank, with a unified interface for fast, reliable data transfer and sharing. This webinar introduces Globus for ActiveScale, a cost-effective solution for on-premise object storage that’s simple to deploy and use. With Globus for ActiveScale, researchers have access to advanced capabilities for managing data across a broad range of systems, while administrators gain a cost-effective, scalable, and durable solution they can deploy quickly to help their researchers innovate faster. In this webinar, attendees will learn how to deploy and use Globus for ActiveScale -- the session includes a product demonstration and a Q&A session with the Globus Chief Customer Officer.
Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and patients continue to be one of the biggest challenges. The challenge is augmented by the lack of standardized methodology for suppliers to execute extractable studies that meets end user requirements. The end users are responsible and required by law to assess the impact of extractables and leachables on overall Product Quality and Safety. Due to lack of a standard, customized data had to be generated for/by each end users. This resulted in long lead times, higher costs and inefficient utilization of resources. Typically, the data generation and qualification of single use component can take up to a year, which can impact implementation of single use. BioPhorum Operations Group (BPOG) developed a standardized protocol9 for generating extractable data that would meet user requirements and simplify/reduce implementation time within industry. A standardized protocol gives confidence to suppliers that testing performed by them would meet end user requirements and enable faster implementation. Some suppliers shared the BPOG vision and proactively tested their single use components using BPOG protocol, which has helped expedite the use of their products.
The success of manufacturing relies on the availability of all the resources –personnel, materials, equipment, work instructions - , orchestrated in such a way that the operations proceed in an efficient and predictable manner. This article describes the implementation of a finite scheduling system for biologics production, the foundational work required prior to project launch, lessons learned, and benefits achieved from this deployment.
Many companies have influence in markets because they make essential products. Think about the products all around us the metals, plastics and various other materials that make up our world. We can see how a change in manufacturing processes or supply could influence the whole industry.
We are joined by Dr.Shafiq Kabir, Chief Innovation Officer at Smoltek AB, to learn how companies who rely on only Intellectual Property are working to change the market. Smoltek specialises in nanomaterials and their applications and brings together industry, intellectual property and manufacturers together.
This is essential viewing for anyone interested in nanomaterials/nanotechnology, IP, licensing and market penetration.
With the recent discovery of a special class of organic compounds with aggregation-induced emission (AIE) characteristics, new opportunities have opened for in vitro and in vivo imaging. In combination with advanced polymer encapsulation technologies, AIE compounds are now available as LuminiCell ultra-bright, organic nanoparticles that enable long-term cell tracking and imaging for applications such as cancer research and stem cell biology.
Patent searching is something most IP counsel is very familiar with. It's your day to day when looking at Freedom to Operate, competitive analysis and portfolio management.
However, it can be hard to predict what you need in a search when you are not a technical expert. In this webinar, we will teach you how to construct the most effective searches using boolean and a few other tips and tricks on how to ensure you include all the technical detail you need.
In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.
The utilization of Multivariate Data Analysis (MVDA) techniques at Sanofi Pasteur, Toronto site has demonstrated innovative capabilities for improved process understanding, control and diagnostics. Examples from several successful and high impact applications will be presented. These examples cover the application of MVDA techniques in multivariate process control, root cause investigations and process analytical technology (PAT). The areas of application include fermentation, downstream purification and product formulation stages.
Continuous improvement, risk mitigation and adherence to compliance rely on the successful execution of key initiatives aligned with an organization’s strategic imperatives. This article summarizes the Project and Portfolio initiatives at Shire’s Biologics manufacturing facility at Shire, Lexington, MA site. In addition to practical advice, the authors discuss the need for sound business processes, alignment with Finance and budget cycles, and play special attention to the importance of resource allocation and management.
Time to Market is an essential metric that R&D teams are measured on. This becomes even more important when we are talking about patented chemicals and processes within the Medical, Pharma and Lifesciences.
If your competitor beats you to market all the time and money spent on research and development becomes a sunk cost, but how can data change that for you?
Using patent and journal data you can give your research teams the tools to quickly validate ideas and decide if they are worth pursuing and simultaneously remove the bottleneck that is placed on Data Analysts.
Join this webinar to learn how data can be applied to research and how this could cut costs and reduce time to market.
Engineered materials that integrate advances in polymer chemistry, nanotechnology, and biological sciences have the potential to create powerful medical therapies. Our group aims to engineer tissue regenerative therapies using water-containing polymer networks, called hydrogels, that can regulate cell behavior. Specifically, we have developed photocrosslinkable hybrid hydrogels that combine natural biomolecules with nanoparticles to regulate the chemical, biological, mechanical and electrical properties of gels. These functional scaffolds induce the differentiation of stem cells to desired cell types and direct the formation of vascularized heart or bone tissues. Since tissue function is highly dependent on architecture, we have also used microfabrication methods, such as microfluidics, photolithography, bioprinting, and molding, to regulate the architecture of these materials. We have employed these strategies to generate miniaturized tissues. To create tissue complexity, we have also developed directed assembly techniques to compile small tissue modules into larger constructs. It is anticipated that such approaches will lead to the development of next-generation regenerative therapeutics and biomedical devices.
The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
The focus of this presentation is the application of Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Fluorimetry (DSF) methods to characterize vaccine components and their stability. Additionally, FTIR can be applied for the identification of final vaccine products, and DSF can be used to distinguish different formulations of vaccine candidates. These methods, when used in conjuction, provide valuable information regarding characterization and stability in the final stages of vaccine manufacturing.
The development of a suitable biologic formulation occurs often before analytical methods are validated. Certain chemical modifications are critical to monitor during the development process as they may cause protein instability and reduce biologic efficacy. Aspartic acid isomerization is one such modification, but is arguably the most difficult to detect. Analytical tools to track IsoAsp are discussed that can aid in making formulation decisions before the availability of qualified methods.
As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This webinar will present a concept for setting in-process limits and a case study which allows to understand the underlying rationales and challenges.
The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.
While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.
In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.
Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.