Best Practices for Point of Care Product Development
Learn how to design better devices, expedite project timelines and get your product to market faster. In this white paper, Invetech shares best practices and proven approaches for solving POC commercial, usability and manufacturing challenges so you can design and engineer optimal outcomes.

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Invetech

 

The Continuation of Medical Research while Participant Practice At-Home Isolation and Social Distancing
With most of our daily activities on-hold or modified for the foreseeable future, medical research is a crucial pursuit that continues despite the current environment. Medical research is critical to detecting, diagnosing, reducing, and treating diseases – however, the global pandemic has the potential to disrupt and delay vital research.

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Sanguine Labs

 

Spot-on UV/Vis accuracy with Big Lunatic & Stunner
Verifying the performance of UV/Vis spectrometers is a necessary but time-consuming and labor-intensive step in the development of biologics workflows. Having confidence in the accuracy and precision of an instrument beforehand makes it easier to know the work of verification is worth your time. Big Lunatic and Stunner have always been perfect for anywhere needing fast, low-volume, and highly accurate quantification of proteins and nucleic acids, but now with certified reference materials and new software they’re ready to deliver performance verification quicker and easier.

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Vetting a Contract Manufacturing Partner for Your Clinical Diagnostics Kit
Do you know your OEM Partner? Choosing the correct contract manufacturing partner for your clinical diagnostics kit is one of the most critical business decisions made during commercialization. The wrong partner could put your business and product at risk.

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DNA leaks before capsids pop: AAV thermal stability on Uncle
Characterizing viral stability for gene therapies using adeno-associated virus (AAV) vectors is a complex task and requires understanding behaviors of whole viral particles, viral genomes, and capsid proteins. Serotypes, formulations, manufacturing methods, and storage conditions all need to be evaluated for their impact on stability. Functional assays, like transduction or infectivity assays, take days and require highly skilled users, while electron microscopy is low throughput and expensive. Even routine assays like AAV ELISAs, which can be used to measure intact capsid titers, or qPCR, which looks at genome quantification, can take several hours. Uncle is ready to help by combining thermal ramp studies with versatile analytical tools to give stability insights that look at capsid, protein and DNA behavior all on the same instrument and in the same experiment. With Uncle, results come in under 2 hours so you can screen more candidates, formulations, or conditions and get to the right answers quickly.

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Rapidly Discover and Select Potent Ligand/Receptor Blocking Antibody Lead Candidates with Opto™ Plasma B Discovery
In this application note, we demonstrate how Opto Plasma B Discovery enables the rapid selection of receptor-ligand blocking antibodies using the therapeutically-relevant PD-1/PD-L1 model system. We also show that by screening not only primary single B cells from the spleen but also those from bone marrow, we were able to discover more blocking antibodies and identify unique candidates that may be missed using traditional hybridoma technology. Using the PD-1/PD-L1 interaction as a model system, we demonstrate that multiple binding and blocking assays enable the selection of 46 unique lead candidates capable of blocking the interaction between PD-1 and PD-L1. We also show that 3x as many antibodies can be identified using bone marrow B cells compared to B cells from the spleen, expanding the diversity of lead candidates. The ability to perform a comprehensive screen on the B cell repertoire using multiple assays to identify functionally-relevant lead candidates against your target of interest – in just one day – may reduce the time and effort to bring new, efficacious therapies to the clinic.

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Biomonitoring Tools for SARS-CoV-2 and other disease threats in Air, Surfaces, and Liquids for Public Health
In the current reality of the COVID-19 pandemic, facilities such as hospitals, senior living centers, prisons, schools, event spaces, transportation, even industry may be operating blindly when it comes to surface, fomite, and aerosol contamination. However, traditional methods for aerosol and surface monitoring for bacteria and viruses are negatively affected by limited collection volumes, poor sample recovery, and complex and difficult to perform recovery processes. InnovaPrep offers novel systems that provide simple and straightforward methods for collection and detection of SARS-CoV-2 and other pathogens at previously undetectable levels.

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Reaching the High-Hanging Fruit: Accessing broad B cell diversity to select better lead candidates in under 1 week
Over last three decades we have developed antibody therapies against a host of diseases including autoimmune, infectious diseases and cancer. Traditional technologies are unable to screen the entire B cell repertoire. As a result antibody therapies have only been developed against simple targets with limited success for more difficult targets such as GPCRs and ion channels. To access these new antibodies against more difficult targets, the high-hanging fruit, will require technology that can functionally screen the entire B cell repertoire. Here we demonstrate how Plasma B Discovery on the Beacon® optofluidic platform can be used to access and functionally screen broad B cell diversity to discover thousands of hits and recover >650 unique, functional antigen-specific antibody sequences in a single workflow that takes less than 1 week.

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Cancer and the Microbiome
The microbiome is an essential player in human health and disease. Gut microbiota dysbiosis associates with several cancers due to microbial products that cause inflammation, oncogenic gene expression changes, or genetic material destruction.  For example, people with colorectal cancer have different microbes in the tumor microenvironment than in adjacent healthy mucosa. These microbes may influence their host’s response to a range of cancer treatments—chemotherapy and immunotherapies, such as checkpoint inhibitors, are more effective in patients with healthy gut microbiomes. 

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Get the whole story: combine Tm and Tagg with sizing and polydispersity on Uncle
Thermal ramp stability measurements (Tm and Tagg) are well-established methods for ranking proteins and formulations for stability. This data is critical for stability determinations, and ensures that researchers are focusing on winning constructs and formulations. While valuable, there is additional information that is not easily gleaned from Tm and Tagg) experiments.

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Accurate Protein Aggregation Analysis by Multi-Laser Nanoparticle Tracking
Protein aggregation is an important concern when developing and manufacturing biotherapeutics since subvisible aggregate particles have been associated with the adverse drug reactions. Therefore, it is important to quantify protein aggregation and particle formulation due to various stresses. In this white paper, we demonstrate with case studies on how multi-laser nanoparticle tracking analysis (NTA) approach allows polydisperse samples and much larger range of particle sizes to be visualized.

The HORIBA Group of worldwide companies provides an extensive array of analytical instruments. Included in the Scientific segment are Raman and Fluorescence spectrometers, ICP-OES, particle characterization and elemental analyzers. The particle characterization has a line up of particle size analyzers that measure from nanometers to millimeters, particle shape, zeta potential, surface area, and nanoparticle tracking.

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Leveraging Years of Data on GPCRs for Transformative Drug Discovery
GPCRs, which play a role in most biological processes, remain one of the most vibrant fields for drug discovery. Years of data are increasingly being leveraged to overcome the complexity of GPCR biology and pharmacology and accelerate GPCR drug discovery. It is now possible to hope to rationally design drugs with optimal effects, thanks to a better understanding of the concept of functional selectivity. A growing volume of structural data also allows researchers to perform virtual screens with ever-increasing numbers of compounds and suggest new small molecule candidates in mere hours instead of months, allowing the exploration of a chemical space that seems infinite.

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Overcoming Barriers to Translational and Clinical Research
The use of artificial intelligence (AI) technologies is poised to have a major strategic impact on focus and differentiation, which will redefine the clinical data review and cleansing process. This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

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Slashing Your R&D Cost Can Be Easier Than You Think
This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. In this quick read, you will learn about the top benefits of a fail fast methodology, how to use technology to improve research results, and you will get simple tips for getting started.

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The Hollow Fiber Model: In Vivo Screening Assay to Speed Up Your Drug Discovery Process
When a drug discovery project enters the phase of in vivo testing many questions arise: “How reliable is our in vitro data? Did we choose the right lead compounds? Which is the best tumor model to use for in vivo efficacy testing?” The Hollow Fiber Model is an in vivo drug screening assay bridging the gap between in vitro and in vivo testing of anticancer agents allowing for rapid answers regarding drug efficacy with simultaneous evaluation of pharmacokinetic and pharmacodynamic parameters.

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DIY in Lunatic and Stunner with the Homebrew toolkit
Quantifying biologics often requires many kinds of measurements and a lot of tedious downstream data processing. That can mean time-consuming, hands-on work with different instruments and software before you can get the results you need. Big Lunatic makes protein quantification easy with a wide dynamic range that can measure concentrations from 0.02–200 mg/mL so you can skip the manual dilutions. Maximize your throughput with high-speed UV/Vis spectral analysis with just 2 μL of sample and up to 96 samples at a time. The unique microfluidic circuits molded into Lunatic plates ensure that there’s no cross-contamination or evaporation. Pipet your samples right into Lunatic plates, or hook them up to your favorite automation system if you need higher throughput. Tack on 21 CFR Part 11 compliance if you need it.

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Qualifying and Quantifying Plasma Samples with Lunatic
Plasma-based research and biobanking programs have generated abundant interest in cell-free nucleic acid analysis and biomarker discovery. Al­though the quality of plasma can severely impact the success rate of these processes, plasma is typically scored by its perceived color and clarity. Visual assessment of plasma samples can bias their scoring since plasma samples can have the same visual appearance (i.e. color and clarity) yet contain different biological components. Biologi­cally, these parameters are related to hemolysis (pink-red color), icteric serum (orange-dark yellow color), and turbidity (transparent to opaque). Lunatic software can distinguish these samples by quantifying the hemoglobin, bilirubin and protein content, in addition to sample turbidity.

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Whitepapers & Special Reports Archive

Fast & accurate DNA quantification with Lunatic
Fluorescent dye-based assays are one of the predominant methods for quantifying nucleic acids, but they’re bogged down by a lot of steps. If anything goes wrong along the way, the assay needs to be repeated, wasting time and valuable sample. In the typical PicoGreen™ workflow, a DNA standard is serially diluted in the linear range of the fluorescent dye. Then, the standards are diluted in a working solution of the dye to create a standard curve. Finally, the samples are diluted in the working dye solution and the DNA concentration is determined. This process is time-consuming and error-prone, and can also yield inaccurate results if the samples are in an incompatible buffer or saturate the assay.

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How to Upgrade from Nector NTI® to Benchling
In the past decade, molecular biology has evolved tremendously, but sequence design software has stagnated. With Vector NTI® set to be officially discontinued by Thermo Fisher, now is the ideal time for life science R&D organizations to digitally transform their molecular biology with a modern, cloud-based platform. This paper outlines the critical software needs for modern molecular biology, and how top-10 pharmaceutical companies have accelerated their research with Benchling's platform-based Molecular Biology application.

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Uncle Application Compendium
Uncle is an all-in-one platform that combines fluorescence, static light scattering (SLS) and dynamic light scattering (DLS) detection methods to enable twelve stability applications on a single instrument. These three detection methods make it possible to collect data on thermal melting, aggregation, and sizing with the same set of samples, greatly reducing protein sample volume requirements and the need to use multiple single-measurement instruments to determine stability.

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Profiling Oncology Drug Candidates Through Complementary in vitro Assays and in vivo Models to Better Understand Their Potential Clinical Applications
In the lead optimization and candidate selection stages of drug discovery, diverse yet complementary investigations can provide a comprehensive profile of a compound's activity, efficacy, and safety. To obtain as complete a profile as possible, orthogonal approaches–including in vitro binding and biochemical assays, cell-based assays, and in vivo safety and efficacy models–can collectively provide insights into the potential clinical utility of a compound. In this white paper, we describe a profiling strategy that includes both in vitro and in vivo approaches to characterize sorafenib, an ATP-competitive multi-kinase inhibitor with clinical applications in multiple cancer types.

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Eurofins

 

Automated platform buffer screening for multiple proteins on Big Kahuna
The critical process of screening formulation buffers to optimize stability is labor-intensive and time-consuming, which is often a limiting factor in biologics development. The conformational, chemical, and colloidal stability of a protein are strongly influenced by the buffer solution. Altering buffer salts, pH, ionic strength, excipients, and surfactants may increase or decrease the stability of a molecule. To alleviate some of the time requirements in developing a new biologic molecule, a platform buffer screen is typically used to screen common formulation conditions to quickly narrow down optimal buffer conditions. A platform buffer screen analyzes the stability of a new molecule with common buffers, excipients, and surfactants in common pH ranges.

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Automated platform buffer screening for multiple proteins on Big Tuna
The critical process of screening formulation buffers to optimize stability is labor-intensive and time-consuming, which is often a limiting factor in biologics development. The conformational, chemical, and colloidal stability of a protein are strongly influenced by the buffer solution. Altering buffer salts, pH, ionic strength, excipients, and surfactants may increase or decrease the stability of a molecule. To alleviate some of the time requirements in developing a new biologic molecule, a platform buffer screen is typically used to screen common formulation conditions to quickly narrow down optimal buffer conditions. A platform buffer screen analyzes the stability of a new molecule with common buffers, excipients, and surfactants in common pH ranges.

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Advanced HDX-MS and Native-MS for Improved Biologic Candidate Selection and Development
Despite substantial efforts utilizing a diverse set of biologic evaluation and high- throughput techniques to select candidates with the best chance of success in preclinical development, the vast majority of biologic drug molecules fail in clinical trials. With most biologic drugs, including gene therapies, failures are realized in late-stage development, after substantial investment has been made in a candidate. Here, we discuss the potential for improving identification of potentially successful biologic drugs and de-risking CMC and clinical designs earlier through strategic application of advanced mass spectrometry, and specifically, how detailed assessment of target engagement using HDX-MS and Native-MS analyses may provide understanding to guide biologic development decisions.

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High-throughput automated pH measurements for biologics formulations on Big Kahuna and Junior
One of the major challenges in biologic drug development is the need to characterize formulations of drug candidates. One significant bottleneck in this process is pH measurement of formulations. Measuring pH is ubiquitous in the laboratory and critical for preparing buffers, analyzing formulations, monitoring stability, and numerous other applications during formulation development.

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Native Analysis of Monoclonal Antibodies by Microchip Capillary Electrophoresis-ESI-MS
The characterization of intact monoclonal antibodies by mass spectrometry is challenging due to the size and complexity of the molecules. The ability to separate charge variants in a separation that is directly coupled to the mass spectrometer greatly improves the MS analysis by minimizing spectral overlap of similar variants, while also providing a charge variant separation which aids in identification of the species. We have previously demonstrated the ability to do such an analysis using microfluidic capillary electrophoresis – ESI-MS under “near native conditions”. This current work extends that capability by operating under fully native conditions which maintain the folded structure of the molecules both during the CE separation and through the ESI transition into the gas phase.

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908 Devices

 

Blast through your problems: ID inorganic and metal particles with LIBS on Hound
The presence of visible and subvisible particulate matter is a risk throughout the development, packaging, and delivery of biologic drugs. There are many sources of potential particulate contamination. Inherent particles, like protein aggregates, come from the formulation itself. Significant contamination risks can come from intrinsic sources such as metal fragments or filter fibers from processing equipment, or glass chips from primary packaging. Extrinsic sources like hair or clothing fibers are also contamination risks. The list of potential contaminant spans protein, organic, inorganic and metal particulates.

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Uncle sets a new benchmark for protein characterization
The monoclonal antibody reference material distributed by the National Institute of Standards and Technology (NIST) has been extensively characterized by many researchers, and has become an excellent standard for the biopharmaceutical industry. The large body of data that has been collected and shared on this molecule is invaluable for verifying analytical methods across research and process development groups. In this application note, we describe NISTmAb data collected on the Uncle platform that demonstrates the versatility, reliability and ease-of-use of the instrument.

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Cross-functional Collaboration Is Key to Diagnostic Test Commercialization
With advances in molecular and genetic technologies and growing patient demand for more personalized laboratory developed tests (LDTs), the demand for such tests is booming. However, even with these favorable conditions, there are significant challenges in bringing new LDTs to market. With so many new tests being introduced, payers have a hard time wading through the noise to identify those that will be beneficial to their business and their patients. To seize upon new business opportunities and meet market demands for new LDTs as well as take full advantage of the new rates for molecular and genetic lab tests, organizations that provide and develop diagnostic lab tests need strong cross-functional interaction between the revenue cycle and the lab.

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Knock out same-time protein concentration and quality with Stunner
Sensitive, quick methods for evaluating protein quality prior to extended characterization studies or assay development save time and precious sample. Uncover more about your samples with Stunner, which combines high-speed UV/Vis analysis with dynamic light scattering (DLS) to measure the concentration and quality of your biologics. Stunner has a wide dynamic range, measuring proteins from 0.02−200 mg/mL, and applies a wavelength-specific correction that provides more accurate values. At the same time concentration is measured, Stunner uses DLS to measure the hydrodynamic diameter of your samples and identify whether aggregates might give cause for concern.

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Take a snapshot of your protein quality with Uncle
Evaluating the quality of samples prior to downstream analysis is an integral part of protein characterization workflows. There are many reasons to quickly assess the quality of a protein sample, such as comparing batches of purified material, changing formulation conditions, or checking the integrity of frozen samples after thawing. Even after initial protein stability assessments are performed, there may be instances in which sources of physical or chemical stress, such as oxidation or agitation by sample mixing, can lead to protein unfolding or aggregation prior to downstream analysis. Considering all the ways in which protein quality can be affected by long term storage or handling, performing a fast quality check can save time and ensure sample integrity. Uncle can reliably evaluate the stability of your biologics by using two different measurement modes.

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Meet Stunner: The one-shot protein concentration and sizing combo
What if you could get a better read on the quality of your biologics and use less sample at the same time? Stunner takes your protein characterization to the next level by combining high speed UV/Vis spectral analysis with Dynamic Light Scattering (DLS). Using micro-volume Stunner Plates, Stunner measures both the concentration and quality of 96 samples in just 1 hour. The Stunner Plate uses 2 µL of sample and there’s no risk of contamination or evaporation. Measure highly concentrated samples straight up so you don’t introduce error by making manual dilutions. Pipet your samples right into the Stunner Plate or hook it up to your favorite automation system if you need high throughput. Tack on 21 CFR Part 11 compliance if you need it. You choose how to sync up your sample quantity and quality measurements.

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Meet Big Tuna: automated, versatile buffer exchange
The critical process of screening formulation buffers to optimize stability is labor intensive and time-consuming, which is often a limiting factor in biologics development. The conformational, chemical, and colloidal stability of a protein are strongly influenced by the buffer solution. Altering buffer salts, pH, ionic strength, excipients, and surfactants may increase or decrease the stability of a molecule. Conventional exchange methods are labor-intensive, prone to inconsistency, and difficult to manage in larger numbers. Existing methods for buffer exchange have various limitations, all of which are exacerbated at higher throughput. Automated buffer exchange systems can enable more uniform sample handling and degrees of process control that are otherwise impractical by manual methods. Big Tuna was developed to address gaps in low-volume, high-throughput buffer exchange.

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The New World of GPCR Allosteric Modulation: Another Shot on Goal
Although historically GPCRs have been a rich source of new drug molecules, the discovery of unique drug types for this target class has waned in the last 3 decades. In the same time frame, the emergence of functional screening and the appreciation of the allosteric nature of GPCRs has revitalized the field and led to an explosion of activity that has transformed GPCR discovery.

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96 Bottles of Beer: Metabolic Profiling of Spent Growth Media Using Rapid, High Throughput Capillary Electrophoresis-Electrospray Ionization-Mass Spectrometry
Bioreactor monitoring is a vital part of quality control and process refinement. There is an ever-growing demand for high throughput analysis methods capable of delivering metabolic profiling data rapidly to the user without the need for extensive sample processing. The presence and concentration of biogenic analytes can often indicate the progress and success or failure of the production process. Beer production is no exception to this as several metabolites have been identified as indicators of beer quality. Here we demonstrate the detection and quantitation of several biogenic amines that have been shown to affect beer flavor.

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908 Devices

 

Using Artificial Intelligence To Determine Patient Response To Immunotherapy
While the current diagnostic strategies for PD-L1 checkpoint inhibitors identify some responders well, the majority of patients still need diagnostic approaches that better predict response. PD-L1 IHC remains a valuable tool for predicting patient response, but can be limited by the ability to correctly use the test to interpret the complex underlying biology and response profile. New IHC interpretation methods are capturing this biology and defining better patient selection tests, but the interpretations are complicated and hard for pathologists to implement.

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Figure out aggregation early: simultaneous, independent measurements of B22 and kD on Uncle
With the trend in biopharmaceuticals to move towards high concentration therapeutics, devel­oping a well-formulated biologic is more import­ant than ever. After ranking and refining down to a set of highly stable molecules, or honing down to good formulations with measurements like Tm and Tagg, the next critical step is reducing the risk of candidates aggregating at high concen­trations. The diffusion interaction parameter (kD) and the second virial coefficient (B22) are both well-established parameters for predicting the colloidal stability and the aggregation propen­sity of proteins. These measurements may be used to confirm stability and minimize the risk of your molecule interacting with itself. With just minutes needed to collect the data, and experi­ments done at lower concentrations, do it earlier in your process and save time and sample.

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Get the whole story: combine Tm and Tagg with sizing and polydispersity on Uncle
Thermal ramp stability measurements (Tm and Tagg) are well-established methods for ranking proteins and formulations for stability. This data is critical for stability determinations, and ensures that researchers are focusing on winning constructs and formulations. While valuable, there is additional information that is not easily gleaned from single-mode instruments. DLS data from Uncle provides even more data on the same set of samples to fill in the missing pieces.

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The Rise of The Biologists: The Changing Face of The Bioinformatics Industry
As in-depth biological knowledge is increasingly a prerequisite for research success, a shortage of bioinformatic skills presents an exciting opportunity for research biologists. In this whitepaper we discuss the context, risk and Thomson Reuter’s first application made specifically for bench biologists.

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Turning Data Into Insight: Cognitive Search & Powerful Analytics for Life Sciences
Finding relevant knowledge in the complex and diverse data of Biopharma companies requires cognitive systems using Natural Language Processing (NLP) capable of “understanding” what unstructured data from texts and videos is about. This whitepaper highlights how Cognitive Search and Analytics are key elements for driving innovation, improving the efficiency of research, clinical trials, and regulatory processes.

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The insideHPC Guide to Genomics Dell has teamed with Intel® to create innovative
solutions that can accelerate the research, diagnosis and treatment of diseases through personalized medicine. The combination of leading-edge Intel® Xeon® processors and the systems and storage expertise from Dell create a state-of-the-art data center solution that is easy to install, manage and expand as required. Labelled the Dell Genomic Data Analysis Platform (GDAP), this solution is designed to achieve fast results with maximum efficiency. The solution is architected to solve a number of customer challenges, including the perception that implementation must be large-scale in nature, compliance, security and clinician uses. Read this white paper to learn more.

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Enabling Data Transfer Management and Sharing In the Era of Genomic Medicine
As sequencing technologies continue to evolve and genomic data makes its way into clinical use and medical practice, a momentous challenge arises−how to cope with the rapidly increasing volume of complex data. Issues such as data storage, access, transfer, sharing, security, and analysis must be resolved to enable the new era of genomic medicine.

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Turning Genomics Data into Practical Insight Given
the prodigious output of Next Generation Sequencing (NGS) instruments, high performance computing (HPC) has become the only practical way to sift through the data to discover useful insight, a point made clearly in a recent Nature Perspective, “The major bottleneck in genome sequencing is no longer data generation — the computational challenges around data analysis, display and integration are now rate limiting … Adequate computational infrastructure … including sufficient storage and processing capacity to accommodate and analyze large, complex data [is needed].”

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Instrument Utilization: The Missing Piece of Asset Management
Instrument Utilization is a critical component of modern lab operations. As research and lab workflows evolve, the use of different instrumentation ebbs and flows. These changes are hard to predict and quantify but have substantial impact on the efficiency of your lab. In this white paper you will get an overview of typical strategies for measuring utilization and learn about new technology emerging in the space.

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Regulation of mobile medical apps
The FDA and European regulators encourage the development of mobile medical apps to enable patients to manage their own health and wellbeing, yet the regulatory status of a smartphone remains a source of confusion. Novarum DX, has produced a whitepaper which provides guidance on the regulation of mobile medical apps.

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Improving Charge Variant Analysis with Maurice Native Fluorescence
Most post-translational and degradation events affect the biological activity of therapeutic proteins, making charge heterogeneity analysis a critical quality attribute for molecule characterization. Both iCE280 and iCE3 use protein absorption at 280 nm to monitor charge heterogeneity, and now Maurice adds native fluorescence detection to greatly increase cIEF capabilities. Maurice’s native fluorescence detection for cIEF works by measuring the fluorescence emission of tryptophan’s aromatic group. It’s labelfree so you’re not wasting time optimizing protein labeling or dealing with the background noise when label unconjugates from your protein. Baselines are significantly cleaner and less sensitive to ampholyte interference, giving you more options when optimizing your pH gradient.

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See What Light Obscuration Misses with Micro-Flow Imaging
Subvisible particles are a critical quality attribute for pharmaceutical products as protein aggregates can elicit an immunogenic response that affects the therapeutic's efficacy.¹Regulatory agencies require a full analysis of any particles present in a therapeutic product, including quantitative measurements of size and count and information on the type of the particles. Compendial methods like Light Obscuration (LO) don’t give you complete profiles due to gaps in their analysis, creating more risk during QC or when you need to file New Drug Applications (NDAs). Micro-Flow Imaging (MFI®) on the MFI 5000 Series system fills in those gaps because it sees particles LO can’t — making it the perfect complement for your regulatory submissions. The system classifies proteins and non-protein particles and gives you direct, image-based detection of size, count and shape for sub-visible particles between 1-300 microns in solution.In this white paper, we’ll highlight the differences between MFI and LO using published literature to help you learn more about how MFI can improve your particle analysis.

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High Fidelity Detection of Endogenous PD-L1 at Low Picogram Levels with Simple Plex Assays
Enlisting a patient’s own immune system to fight cancer has been a longstanding dream for cancer biologists. Immune checkpoint inhibitors targeting molecules like programmed death-ligand 1 (PD-L1) help make the dream a reality and are now transforming today’s cancer therapy. PD-L1 therapy has gained interest as a paradigm shifting approach to cancer treatment due to its durable effects, and its ability to target a broad range of cancers1,2,3 with manageable toxicity compared to traditional chemotherapy. In this application note, we compare endogenous PD-L1 detection in PTEN mutated glioma cell supernatant and blood cells using the Simple Plex assay and a commercially available sandwich ELISA assay to demonstrate data equivalency and the added sensitivity you’ll get with a Simple Plex assay.

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5 Ways to Manage the Rising Costs of Benefits for small and medium-sized businesses
A robust benefits package can be the difference between a talented superstar choosing to work with you as opposed to a larger, more establishedcompetitor. But with the cost of benefits rising each year, providing a benefits package that helps you attract, retain, and motivate talented peoplegets harder all the time.With knowledge and planning, you can create a win-win situation for yourself and your employees. You can use benefits to meet the needs of yourworkforce and successfully compete for top talent. As a business owner, it’s important to be aware of the ways you can manage costs and attract tophires.

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Turning Text into Insight: Text Mining in the Life Sciences
Given the volume of scientific literature and the pace at which it is published, it’s neither feasible nor cost-effective for researchers to read and analyze this material one article at a time. Life science researchers use text mining tools to analyze massive amounts of information quickly to extract data, assertions, and facts. Read this paper to learn about text mining and three approaches to maximize its efficiency and potential for discovery.

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Enabling Data Transfer Management and Sharing In the Era of Genomic Medicine
As sequencing technologies continue to evolve and genomic data makes its way into clinical use and medical practice, a momentous challenge arises−how to cope with the rapidly increasing volume of complex data. Issues such as data storage, access, transfer, sharing, security, and analysis must be resolved to enable the new era of genomic medicine.

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Turning Text into Insight: Text Mining in the Life Sciences
Given the volume of scientific literature and the pace at which it is published, it’s neither feasible nor cost-effective for researchers to read and analyze this material one article at a time. Life science researchers use text mining tools to analyze massive amounts of information quickly to extract data, assertions, and facts. Read this paper to learn about text mining and three approaches to maximize its efficiency and potential for discovery.

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The insideHPC Guide to Genomics Dell has teamed with Intel® to create innovative
solutions that can accelerate the research, diagnosis and treatment of diseases through personalized medicine. The combination of leading-edge Intel® Xeon® processors and the systems and storage expertise from Dell create a state-of-the-art data center solution that is easy to install, manage and expand as required. Labelled the Dell Genomic Data Analysis Platform (GDAP), this solution is designed to achieve fast results with maximum efficiency. The solution is architected to solve a number of customer challenges, including the perception that implementation must be large-scale in nature, compliance, security and clinician uses. Read this white paper to learn more.

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Turning Genomics Data into Practical Insight Given
the prodigious output of Next Generation Sequencing (NGS) instruments, high performance computing (HPC) has become the only practical way to sift through the data to discover useful insight, a point made clearly in a recent Nature Perspective, “The major bottleneck in genome sequencing is no longer data generation — the computational challenges around data analysis, display and integration are now rate limiting … Adequate computational infrastructure … including sufficient storage and processing capacity to accommodate and analyze large, complex data [is needed].”

Click here to access

 

Turning Data Into Insight: Cognitive Search & Powerful Analytics for Life Sciences
Finding relevant knowledge in the complex and diverse data of Biopharma companies requires cognitive systems using Natural Language Processing (NLP) capable of “understanding” what unstructured data from texts and videos is about. This whitepaper highlights how Cognitive Search and Analytics are key elements for driving innovation, improving the efficiency of research, clinical trials, and regulatory processes.

Click here to access

 

The Rise of The Biologists: The Changing Face of The Bioinformatics Industry
As in-depth biological knowledge is increasingly a prerequisite for research success, a shortage of bioinformatic skills presents an exciting opportunity for research biologists. In this whitepaper we discuss the context, risk and Thomson Reuter’s first application made specifically for bench biologists.

Click here to access

 

Instrument Utilization: The Missing Piece of Asset Management
Instrument Utilization is a critical component of modern lab operations. As research and lab workflows evolve, the use of different instrumentation ebbs and flows. These changes are hard to predict and quantify but have substantial impact on the efficiency of your lab. In this white paper you will get an overview of typical strategies for measuring utilization and learn about new technology emerging in the space.

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5 Ways to Manage the Rising Costs of Benefits for small and medium-sized businesses
A robust benefits package can be the difference between a talented superstar choosing to work with you as opposed to a larger, more establishedcompetitor. But with the cost of benefits rising each year, providing a benefits package that helps you attract, retain, and motivate talented peoplegets harder all the time.With knowledge and planning, you can create a win-win situation for yourself and your employees. You can use benefits to meet the needs of yourworkforce and successfully compete for top talent. As a business owner, it’s important to be aware of the ways you can manage costs and attract tophires.

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Getting the Whole Picture for Immuno-Oncology Therapies
Diagnostics that identify the targets of a drug have been a cornerstone in conveying the value of precision medicine approaches. In the past, patient selection for classic targeted therapeutics was based on a single biomarker using a single assay involving a single methodology (e.g., HercepTest™); however, a lot has changed since the approval of Herceptin® nearly 20 years ago. The first-generation immune checkpoint inhibitors such as YERVOY®, OPDIVO®, KEYTRUDA®, TECENTRIQ®, and BAVENCIO® have transformed the way we approach cancer therapy. Now, the profile of the patient’s immune system and its interaction with the tumor is considered as much as the target of the therapy itself.

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Why Declining Returns on R&D Demand Better Workflow Efficiencies
Ask ten people to define innovation and it’s likely that you’ll get ten different answers. Most would agree, though, that it includes some combination of a good ideas, solves a real problem, is executed well, and adds value to the company. But while it may seem intuitive that investments in R&D lead to greater profits, it’s really not all that cut and dried. Not all R&D investments are created equal, and they certainly don’t all produce the same results. For example, R&D activities may not be focused on the right problems, and even when they are, they may not, for a variety of reasons, pan out in the profitability department. And then there’s competition.

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Acquiring Scientific Content
SO CLOSE AND YET SO FAR Is that how many documents seem to you? Indeed, getting what you want—when, where, and how you want it—can be a real uphill battle. It’s a process that can be fraught with difficulties, not the least of which includes the overwhelming volume and complexity of content and the myriad ways of accessing and managing it. And that’s true for everyone involved, from the content licensors to the aggregators to the librarians to the end users.

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Reducing Cycle Time with Digital Transaction Management
This eBook provides best practices to drive digital adoption in life sciences, including how you can: Reduce Cycle Time, Improve Trial Enrollment and Informed Consents, Simplify Operations & Approvals.

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DocuSign Life Science Solutions for Regulated Life Science Operations
The pressure has never been greater for life science organizations to shorten the development cycle for new drugs and devices — and to do so while cutting costs and complying with industry regulations like 21 CFR Part 11 and Annex 11. DocuSign makes it easier and more efficient for you to adopt digital approvals, agreements and processes for regulated life science use cases. To fuel your digital success, we have outlined DocuSign’s options to help you implement e-signature and digital platform solutions while adhering to life science regulations: DocuSign Life Sciences Module, DocuSign Signature Appliance, Third Party Industry Credentials and Process Validation

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Acquiring Scientific Content: How Hard Can It Be?
SO CLOSE AND YET SO FAR. Is that how many documents seem to you? Getting what you want—when, where, and how you want it—can be a real pain. That’s why we created this concise guide to getting around the obstacles that stand between you and the information your organization needs.

Download it here and learn how to:

  • Avoid busting the budget on expensive subscription access
  • Acquire even the most elusive content with equal ease
  • Slash delivery turnaround time from days to minutes

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IC3D — “Finding your Needle in a Haystack”
In healthcare today, better and faster diagnostics lead to better treatment and outcomes for patients. The challenge in many situations is that the existing tools are simply lacking in terms of speed, sensitivity, and accuracy. This problem is even more pronounced when one needs to “find that small needle in a haystack” and assess rare targets (specific cells, proteins, DNA, RNA, etc.) quickly and accurately in complex patient samples (whole blood, plasma, urine, etc.). A similar problem also persists in other industries such as pharmaceutical manufacturing and food safety, where a rapid test for biological testing (e.g., microbial contamination) would save time, money, and improve safety.
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IC3D — “Droplet by Droplet” to Single Target Sensitivity
The most critical challenge of assessing rare targets in large-size samples is how to overcome the problems of (1) finding the needle in a haystack, and (2) extremely low signal-to-noise ratio. With the exceedingly low abundance of the targets against the immense “swamp” of the background, any faint signal by the targets is probably swamped by the background chatter. In the IC3D technology, we have two “magic tricks” working in tandem to solve this long-standing challenge.
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Drug Discovery Toolbox: Summary of results from peer reviewed publications, key features and technology
The audience will learn how this device enables implementation of infusion protocols to reliably and precisely achieve the desired exposure profiles (shapes and timing) with low degree of invasiveness. All summarized from peer reviewed publications and PhD thesis. Targeted and systemic delivery using catheters (iv, sc, intrathecal and ip) and brain infusion kits with chrono-release, intermittent and continuous drug delivery examples. Results requiring frequent refilling, every 2-3 days will also be presented.
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AlliedMercury Innovative Supply Chain Partners Are Good Medicine
In this white paper we’ll explore how a customized and integrated supply-chain creates both significant business advantages and superior results. Making sure that your products reach the right people on time is a mission-critical essential in today’s world. There is no room for error in any part of the process. Your long-term viability depends on it.
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Wiley Chem Planner Synthesis Solved
In this case study, Wiley ChemPlanner was applied to help a chemist identify alternative and shorter synthetic routes to target molecules. Options that were not known to the chemist and would likely not have been identified by searching the literature with traditional search tools were found. ChemPlanner thus helped the chemist to increase the efficiency of the synthesis development process by reducing the time and resources spent.
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Syngeneic mouse models as a tool to study immune modulatory effects of cancer therapeutics
Every cancer treatment has the potential to induce a stimulatory or inhibitory effect on the immune response to a tumor. Scientific knowledge about the significance of the immune system for tumor eradication during conventional treatment is growing quickly, and an increasing number of immune-modulating drugs are entering clinical trials for cancer treatment.
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Better Antibody Screening Whitepaper
Learn how adopting High Throughput Flow technology has enabled leading biotechnology companies to improve their antibody screening.
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Next Generation Phenotypic Screening Whitepaper
Learn why some large pharmas are incorporating phenotypic screening as part of their drug discovery strategy and what technology challenges still remain.
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Developing a Bioformulation Stability Profile
Here we describe the development of a bioformulation stability profile, derived from sub-micron light scattering and micro-capillary viscometry to assess the stability of bioformulations.
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Best Ultrasensitive Tau Assay Enables Quantification of Neuronal Biomarker
It has been well established that the neuronal protein tau has an important role in the diagnosis of Alzheimer's disease (AD).
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Lab Workstation Automation
“You have to walk before you can run.” You’ve heard it in other contexts, but is it true in laboratory automation? Our experience indicates that it is. We’ve also learned that trying to automate everything at once is a prescription for disaster. Like the human progression from crawling to walking to running, labs that choose to automate do it most successfully in a logical sequence of steps, or phases, each one building on the foundation of the last.
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Fast and Accurate Sample ID in the Lab
Laboratories—whether clinical, analytical, or pure research—can scarcely automate today without barcodes. While other technologies may someday offer more cost-effective ID techniques, barcodes are generally the best technology for positive sample identification within modern labs.
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Scientific Principle of Simoa Technology
Quanterix has developed an approach for detecting thousands of single protein molecules simultaneously.
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Best Practices in Hiring for Diagnostic & Laboratory Testing Industries
If you are responsible for hiring, you are in the success business. And when the people you hire are successful it is likely that your company will be successful too.
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Enabling Data Transfer Management and Sharing In the Era of Genomic Medicine
As sequencing technologies continue to evolve and genomic data makes its way into clinical use and medical practice, a momentous challenge arises−how to cope with the rapidly increasing volume of complex data. Issues such as data storage, access, transfer, sharing, security, and analysis must be resolved to enable the new era of genomic medicine.
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Enterprise Informatics: Key to Precision Medicine, Scientific Breakthroughs, and Competitive Advantage
Given their level of investment in data and data management systems, healthcare delivery and life sciences organizations should be deriving considerable value from their data. Yet most organizations have little to show for their effort; the capabilities of their systems are highly compromised, and the practice of precise, evidence-based medicine remains elusive. The fact that these institutions have spent many years collecting data and building infrastructure for so little return has, for many, become “the elephant in the room”—a painfully obvious and uncomfortable topic of conversation.
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