Accelerating and Automated Rapid Microbial Testing
Rapid microbial testing methods in quality control continue to gain acceptance in pharmaceutical manufacturing, but most companies continue to use manual, traditional methods. The ability to uncover results in less time than traditional methods provides compelling benefits to manufacturers. These benefits can be realized in environmental monitoring, sterility testing, water and bioburden testing.
Learn from experts where rapid technologies, like the Growth Direct™ System can have an impact on microbial quality control and ultimately manufacturing.
Attendees will learn:
- The limitations of the traditional methods
- The importance of non-destructive testing
- The benefits of automated, rapid detection
Petr MD, a Russian Neurosurgeon, is going to present a case of a surgical intervention of an acute stroke, the results, and will discuss with a round table of Neurosurgeons, in cluding Charles David Hunt MD, Julio Pereira MD, and others
Pieter will be speaking about his Number 1 Neurosurgical app in the world, "Neuromind", as well as other web developments in the medical field, including his work in the IT department of his hospital, as well as his passion for Medical Infomatics
Cerepro is an app designed for patients with Traumatic Brain Injury, by a patient who, himself, suffered this type of injury. He discusses the purpose of this app to rehabilitlate Traumatic Brain Injury Patients in both their focal motor, and memory skills.
Our webinar will explore:
- How to turn local NHS data into intelligence
- Understand local issues and ways to overcome challenges
- Explore opportunities for joint working between the NHS, charities and Pharmaceutical Industry
Please let us know if there is a specific locality you would like us to explore in the webinar via #WickedMindsWebinar or firstname.lastname@example.org
Learn how to deliver integrated health and social care with big data and interoperability.
The Caldicott 2 report highlighted the practical difficulties that surround the sharing of service user data, especially when it’s not being used for direct care. Yet you still need to utilise big data and data sharing to comply with government policies aimed at providing better care.
Join us for this half-day executive briefing where experts from NHS England,Dell Healthcare will provide practical insights on how to enable interoperability and the use of business intelligence to better serve your communities.
We’ll show you how your healthcare data can help gain actionable insights, avoid unseen risks and discover missed opportunities using real-world examples.
Get insights on how to:
•Integrate data from different sources (such as the local authority and NHS commissioners)
•Create healthier communities, improve outcomes and lower healthcare costs through the innovative use of data analysis to predict and prevent ill-health
•Improve the patient engagement experience through seamless
•Ensure a more timely exchange of data to meet regulatory
•Create a cloud-based repository for data that can be accessed
from multiple locations and via different applications
Are you ready to transform healthcare with predictive analytics? Are you ready to turn Data into Insights and Insights into Practice? Predictive Analytics is about making better healthcare decisions. Is your organization Future Ready?
Viavi Solutions | Rutgers University / Bristol-Myers Squibb
Near infrared spectrometers have long been the PAT tools of choice for pharmaceutical and industrial scientists seeking to gain physical and chemical information from their samples. More recently, the development of fast and inexpensive miniature NIR instruments has greatly facilitated real-time in-line monitoring of multiple unit operations within a process. NIR can be used as a supervisory tool for multiple critical quality attributes of a drug product. Deviations from the acceptable ranges can be acted on in real-time based upon closed-loop control strategies.
This webinar discusses how miniaturised spectrometers facilitate testing of different control schemes with the goal of enabling real-time feedback control of continuous manufacturing processes.
> Chris Pederson, Product Applications Engineer, Viavi Solutions
Chris will present the principle of operation of the linear variable filter-based miniature NIR spectrometers, i.e., the MicroNIR Spectrometers developed by Viavi Solutions. He will also share key performance attributes of these ultra-compact MicroNIR products, and their applications in the pharmaceutical industry.
> Krizia M. Karry, PhD Candidate at Rutgers University (now with BMS)
Krizia will present results of the MicroNIR spectrometer and its application for testing various control schemes and enabling real time feedback control of a continuous manufacturing process for tablets.
In New Food’s upcoming webinar the analytical importance of colour analysis within the food industry, as well as examples of systems that can be used for colour measurement will be explained by three industry experts; Christian Jansen, European Sales Manager, Hunter Associates Laboratory, Inc., Thibaut Dedreuil-Monet, Technical Specialist, RSSL and Etienne Arman, Analytical Specialist, Jacobs Douwe Egberts (JDE) GB R&D Ltd.
Whether a food product is declared tasty depends on its ingredients, flavor and also the appearance of the final product. In many cases the first sense engaged when someone goes for a food product is vision. Especially with packaging the only way to judge if it’s a good product or not is optics. To measure colour hues of food products in a variety of conditions, complex technical solutions are required. Whether raw materials or solids and liquids, only special spectrophotometers can give precise data to help formulate colour and calculate values or differences. Length of a food process, ingredients, flavour and many more factors influence the appearance of a food product; with detailed analysis manufacturers can meet the ideal optical impression which is attractive for customers to buy the product.
Len Sidisky from Sigma-Aldrich & Dr Peter Q. Tranchida from University of Messina
This webinar will provide an overview on the topic of analyzing various fatty species in foods and methods to determine various classes from total fat to various lipid fractions and the wide variety of analyses available for fat determination. Topics discussed will include the analyses of fatty acid methyl esters (FAMES) in foods and the use of comprehensive two-dimensional gas chromatography (GC x GC) for the enhanced separation of highly complex mixtures. Advances in GC column stationary phases and new phases based on ionic liquid technology for the analyses of saturated and polyunsaturated FAMES will be discussed aswell as the use of GC×GC in the field of food lipid analysis. The considerable advantages of the two-dimensional approach (both with and without MS detection), in experiments related to a series of lipid volatiles (fatty acids, sterols, oxidation products, fatty alcohols, etc) will be illustrated.
In this webinar, we will:
> Overview the wide variety of methods available for the analysis of fat in foods.
> Examine traditional and new classes of GC Stationary Phases for the evaluation of various FAME species.
> Discuss the power of two-dimensional gas chromatography (GCxGC) for separating highly complex mixtures and how it can be combined with mass spectrometry for analyzing volatile and semi-volatile analytes
University College London | European Bioinformatics Institute | Illumina
Drug target validation is a major obstacle to drug development leading to high rates of late-stage failure because the pivotal study in drug development - the randomised trial – occurs at the end of the development pipeline.
Genetic studies using the principle of Mendelian randomisation reproduce key elements of a randomised trial ensuring target validation can take place earlier in development.
A second major obstacle in drug development is the understanding of individual differences in drug efficacy and safety due to naturally occurring variation in gene encoding proteins involved in drug disposition – a key component of stratified medicines research.
The Illumina Drug Development Array is designed to address issues and enable genomic discoveries to be used in drug development.
The array combines the genome-wide tag SNP content of the Illumina Human Core BeadChip (240,000 highly-informative genome-wide tag SNPs and over 20,000 high-value markers) with a novel 200,000 custom marker set designed to support studies of drug target validation and treatment response. The array is relevant to full range of human drug targets and medical disorders.
The webinar will:
- Introduce the concept of Mendelian randomisation studies for target selection and validation in drug development
- Discuss the concept of the ‘druggability’ and the ‘druggable genome’
- Describe development of the content of the Illumina drug development array based on an updated set of genes encoding druggable targets and the proteins involved in in drug absorption, distribution, metabolism and excretion (ADME)
- Prof. Aroon Hingorani, Chair of Genetic Epidemiology, Institute of Cardiovascular Science, University College London
- Prof. John Overington, Visiting Professor of Computational Chemical Biology, Institute of Cardiovascular Science, University College London
- Dr. Anna Gaulton, Senior Data Integration and Development Officer – ChEMBL, European Bioinformatics Institute, Hinxton
Dr. Iva Navratilova, Chief scientific officer at Kinetic Discovery. Dr. Tim Fagge, Application specialist at GE Healthcare.
G-protein coupled receptors (GPCRs) are the primary target class of currently marketed drugs, accounting for around a third of all drug targets of approved medicines. However, almost all the screening efforts for novel ligand discovery rely exclusively on cellular systems overexpressing the receptors. Current receptor assay systems are based on measurement of either ligand displacement or downstream functional responses, rather than direct observation of ligand binding. Issues of allosteric modulation, probe dependence and functional selectivity create challenges in selecting suitable assays formats. Therefore a method that directly measures GPCR-ligand interactions, independent of binding site, probe and signalling pathway would be a useful primary and orthogonal screening method. An alternative ligand discovery strategy would be the direct measurement of GPCR-ligand interactions by label-free technologies, such as surface plasmon resonance (SPR). However label-free biophysical screening methods have not been routinely applied to membrane proteins. Current developments are looking at improving GPCR biosensor assays for SPR instruments and applying these to a range of drug discovery and biological functions, including kinetic analysis, allosteric discovery, fragment screening and functional selectivity. Biosensor-based direct screening methods enable the identification of the interaction of both orthosteric and allosteric ligands with solubilised, wild type GPCRs, in a label-free and cell-free environment, thus overcoming the limitations of indirect and displacement assay methods.
Bürkert, supported by EHEDG members from Diversey-Sealed Air & Cargill
Hygienic design, regulations & compliances are increasing dramatically in the Food & Beverage market. Consequently, the questions raised are: how can you ensure food safety? How does Hygienic Design support the cleanability & Total Cost of Ownership of your plant? And with a practical example: What does a perfect flowmeter for liquids look like?
As well as speakers from Bürkert, this webinar features presentations from Hein Timmerman of Diversey-Sealed Air & Patrick Wouters of Cargill. Both are members of the European Hygienic Engineering & Design Group, EHEDG.
Patrick will discuss Cargill’s overall goal to provide high quality, safe food, every time, everywhere; to this end, hygienic design is an important pre-requisite. This accounts for the choice of flow meters. Although hygienic design is a critical element, it is more important to have a correct measurement of the flow. This control point is of utmost importance, to ensure that specified functionality is achieved & food safety & product quality is ensured.
Hein will discuss Sealed Air’s Value Added Services on cleaning applications & cleaning validations, which includes remote monitoring tools & software platforms to support their end customers’ requirements for food safety & Total Cost of Ownership.
Bürkert’s John van Loon will discuss their new technology, FLOWave. This answers the hygiene issues other systems could face, by employing surface acoustic waves in a stainless steel tube. As such FLOWave allows a flow measurement of liquids without any parts within the tube. Current methods in industrial flow measurement are mainly based on moving parts like paddle wheels or rigid fixtures such as a bluff body in the measurement tube. These flow metering systems have their specific weaknesses, limiting their range of applications. The measuring task must be fulfilled, reliably, throughout the entire life cycle of the device. Also, the daily operative handling effort should remain within reasonable limits.
Dr. Melanie Nijman, Senior Applications Specialist, Thermal Analysis
Differential scanning calorimetry (DSC) is the most frequently used thermal analysis technique alongside TGA, TMA and DMA. DSC is used to measure enthalpy changes due to changes in the physical and chemical properties of a material as a function of temperature or time. The method allows you to identify and characterise materials. Differential scanning calorimetry is fast, very sensitive and easy to use. In this Webinar, we will discuss the basic principles of DSC and present some interesting applications.
AB Sciex: Jason Causon, Senior Applications Specialist & Remco van Soest, Product Manager
Presentation 1: Jason Causon, Senior Applications Specialist, Sciex
Development of bioanalytical LC-MS methods for the detection of therapeutic peptides and the proteolytic fragments of larger proteins and antibodies is growing along with the increasing number of peptide and protein drugs entering clinical research and development. Development of these methods present challenges that are different to small molecule method development because of the multiple charge states possible for a given peptide, the abundance of product ion possibilities and the large number of proteolytic fragments possible from a protein digest. In addition to optimizing for sensitivity, on-column HPLC method development is time consuming for the same reasons. In this webinar we present an automated tuning and optimization workflow with on-column validation using DiscoveryQuantTM 3.0 software with the new ChromaTune feature to overcome some of these challenges and make the optimization of peptide MRM methods easier and less time consuming.
Presentation 2: Remco van Soest, Product Manager, Sciex
Electrospray Ionization efficiency increases at lower flow rates. In this Webinar we will discuss how microLC can help you improve sensitivity in sample limited applications in bio-analysis by LC-MS. In order to analyse the same volume of sample as is typically injected in a conventional LC-MS system, up to 50 µL, we have developed a microLC system that allows for fast on-line pre-concentration on a short trap column. Because of the higher flow rates that can be used for loading the sample on the trap-column, sample throughput is not affected by using microLC flow rates for the LC-MS analysis.
Nicolas Pierre (Cisbio Bioassays) & William Gowen-MacDonald (Trevena)
Special Guest Terry Kenakin Ph.D. will be taking part in our LIVE Q&A session answering your questions!
[ABOUT THIS WEBINAR]
Ligand bias is a well-established concept in the GPCR research field that is beginning to emerge as a means to optimize GPCR targeted drug design. Most approved medications that target GPCRs act as either agonists or antagonists of heterotrimeric G protein and β-arrestin pathways. In many cases, this classical signaling paradigm leads to both efficacy and on-target adverse events. Biased GPCR ligands have the ability to activate or inhibit with greater selectivity one of the two downstream effector proteins and its subsequent signaling cascades. The goal of this webinar is to illustrate in vitro characterization of GPCR ligand bias and its translation to in vivo proof-of concept using TRV027, an AT1R modulator, as an exemplar biased ligand.
> What attendees will learn about?
• Review of GPCR signaling
• Introduction to concept of ligand bias and quantification thereof
• Utility of 2nd messenger assays in GPCR drug discovery
• Pre-clinical biased ligand proof-of-concept
Nicolas Fedelich, Thermal Analysis Senior Applications Specialist, Mettler Toledo
Thermal analysis instruments must always be accurate, true and precise in order to deliver reproducible results within a given range. Performing a calibration determines whether your module is delivering correctly measured values or whether it needs an adjustment. The different parameters that must be calibrated are temperature, heat flow, mass, length and modulus. In this Webinar, we will discuss the basics of calibration and adjustment in thermal analysis whilst offering some useful tips and hints.
Accelerating Pharma R&D with Novel MS Applications for High Throughput Screening (HTS), Drug Imaging and Integrating MS and NMR data for high confidence structure verification of small molecules.
This webinar will introduce novel MS and NMR solutions and its applications in pharmaceutical research:
> NMR Spectroscopy and Mass Spectrometry are two fundamental techniques for small molecule structure verification. Bruker FUSION-SV - a new software solution for comprehensive fully automated small molecule structure verification – simplifies and accelerates the drug design and discovery phases in the pharmaceutical industry significantly. The new Bruker FUSION-SV™ is a software solution integrating high resolution accurate mass (HRAM) data and complementary NMR data, into one result - increasing significantly the specificity and throughput for small organic molecule structure verification. Synthesis chemists will get a prompt result without being an expert spectroscopist.
> Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) instruments are ideally suited for high throughput screening (HTS) in drug discovery. Not only speed, simplicity and robustness are the convincing arguments for MALDI-TOF MS but the inherent strength of a label- and solvent-free technique. The webinar will explain the technique and advantages of MALDI-TOF MS and present automation solutions for highest throughput and speed (less than 1 second per sample).
> Finally the webinar will describe how the MALDI technology is used for small molecule imaging when coupled to modern 7 T (Tesla) FT-MS instrumentation. Drugs and metabolites can be visualized and distinguished one from the other directly measured from tissue samples. These results can be linked with histological information derived from the very same tissue, giving new insights into drug action and toxicity.
Thermal Analysis is often used to investigate pharmaceutical substances. Polymorphism, pseudo-polymorphism, phase diagrams, stability, and purity determination can all be measured by thermal analysis.
The four main techniques of thermal analysis, DSC, TGA, TMA, and DMA are ideal for characterizing such substances. The chief advantage is that properties can be measured as a function of the temperature or time over a wide temperature range, from –150 to 1600 °C.
In this Webinar, we will show how thermal analysis is used to investigate pharmaceutical substances. We will present some typical examples measured by DSC, TGA, TMA or DMA.
The application of Rapid Microbiological Methods (RMM) in a topic that has gained interest over the past few years as pharmaceutical manufacturers investigate and look to gain improved efficiencies across all areas of their businesses – including the microbiology laboratory. This presentation will show how a rapid method can provide a solution to a common microbiological testing problem for pharmaceutical manufacturers – process water microbiology testing.
*** Presented by Yongqiang Zhang, Senior Scientist, BD Diagnostics:
Examination of the microbiological quality of water used for manufacturing pharmaceuticals is integral to current Good Manufacturing Practices (GMP) and ensuring product safety. Membrane filtration, the conventional method for assessing microbial burden in water, takes three to seven days to complete. Valuable opportunities for intervention could be missed due to a delay in obtaining test results. In this study, we assessed the effectiveness of flow cytometry as a rapid microbiology method for water analysis. The data with four representative bacteria [Burkholderia cepacia, Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus] indicate that a low level bacterial presence in water can be rapidly detected and enumerated. These results highlight the potential of flow cytometry for real time monitoring of the microbiological quality of water in pharmaceutical manufacturing.
*** Presented by Scott Sutton Ph.D. – President of Pharmaceutical Microbiology Forum & Owner of The Microbiology Network
There has been excitement about the potential of RMM in QC microbiology since the ATP bioluminescence method was commercialised in the early 1970s. After 45 years however, pharma microbiology is notable for its lack of adoption of these methods. This presentation will examine this situation and offer some potential explanations, as well as recommendations for better microbiology service to the pharmaceutical industry.
Dr. Marcia Armstrong (Global Scientific Affairs Manager) & Dr. Kathrin Wolf (QIAGEN R&D Scientist)
Live/dead differentiation of microorganisms helps to ensure safe food production
This webinar introduces viability PCR as a fast and powerful tool to analyze food samples for the presence of potentially harmful microbes. Viability real-time PCR utilises the DNA-masking compound propidium monoazide (PMA). PMA enters dead and membrane-compromised pathogen cells and binds to DNA, making the DNA inaccessible to detection by PCR. Live/dead differentiation is important for procedures such as: hygiene testing (success of decontamination processes), water testing (distinguishing between live and dead legionella for regulatory compliance), and several other important applications.
Do you want to learn more? http://www.qiagen.com/gb/landing-pages/detected-dead-or-alive-the-blu-v-way
Dr. Ke Hong (Senior Project Manager, Pfizer Global Supply) & Mrs. Denise Root (NIR Marketing Manager, Metrohm USA Inc.)
Near Infrared spectroscopy as a great PAT tool for pharmaceutical processes-from raw material ID, integrated process control and to final product testing.
This webinar will focus on benefits of using NIR spectroscopy in several pharmaceutical processes. Examples of NIR application for raw material ID, process control testing and final product will be given. Challenges in implementing NIR spectroscopy in the analytical process will be discussed.
Ronald Van Brempt (LUMC) and Mark Gerber, Ph.D. (Sigma-Aldrich)
Optimising target-based assays and streamlining hit-to-lead processes are key for a productive R&D drug pipeline. Researchers in both the pharmaceutical and biotech industries, as well as in academic environments, are increasingly searching for novel technologies and related services that enable them to both innovate and speed up their research pipeline. The creation of disease models for target validation and reporter cell lines for high-content screening assays are good examples of where one needs high-technology knowledge and cell engineering expertise to be able to efficiently create the ideal cell model in a reasonable time frame. Trying to have a grip on novel gene editing knowledge and hands-on experience is a time and cost consuming effort. For this reason, researchers are increasingly deciding to externalize that part of their work, in order to focus on target-specific research and other aspects of drug development.
In this free-to-view webinar we will discuss how the decision was taken on a knock out approach to generate iPSC disease models to more efficiently and quickly validate two potential lung cancer targets. We will also present considerations for undertaking successful cell engineering projects for high-content screening assay development and target validation.
James Drinkwater (Chairman, PHSS) / Tim Russell (TSI)
This webinar will give an overview of the recently released UK Pharmaceutical and Healthcare Science Society (PHSS) Technical Monograph #20- Bio-contamination, characterization, control, monitoring and deviation management in controlled/ GMP classified areas. The concept of Risk Profiling and Proactive Response (RPPR) to bio-contamination in GMP classified areas, focusing on preventing contamination and not just monitoring for compliance will be presented. How trending environmental monitoring data holistically across all supporting areas can detect an increasing risk of a contamination event in Grade A zones will be examined. In particular, the value of using real-time airborne viable particle detection as part of holistic monitoring strategy for risk escalation will be discussed.
Many organizations are pro-actively exploring Rapid Microbiological Methods (RMMs). Real-time airborne viable particle counting is an RMM that is generating great interest. The potential opportunities of improved product quality and efficiencies, whilst maintaining patient safety are too significant to ignore. Cases where this technology is providing value today in a pharmaceutical manufacturing environment will be presented. Included will be a brief discussion of critical performance characteristics of real-time viable particle detectors which should be considered when selecting an instrument to monitor GMP classified areas.
This webinar focuses on new methods and applications in food contamination analysis, bringing together some of the leading experts in food contact materials (FCM) and provides an interactive learning environment for scientists working in this field.
As food quality and food integrity has become a major topic for the consumer, the penetration path of contaminants in our food chain deriving from the food production and/or the food packaging and storage conditions is gaining attention. Fast and reliable ways of sample preparation and analysis are discussed showing up-to-date examples and how the regulations are applied.
** Meet the speakers **
- Sabrina Moret (Associate Professor, Dept. Food Science, University of Udine)
- Duncan Goodwin (Director of Technical Services, NSF)
- Susanne Feifel (Product Group Manager for Kjeldahl, Elemental Analysis and Extraction, BÜCHI)
** What will you gain from this webinar? **
- You will be provided with tangible ways to streamline your sample preparation to detect mineral oil hydrocarbons in cardboard and food as well as bisphenol A in canned food.
- BUCHI´s solutions for these applications are presented using examples from industry.
- Furthermore, you will learn about health and safety risks in the field of food packaging and storage. This will be linked to up-to-date information from the leading regulatory authorities.
Dr. Bernhard Ellinger (European ScreeningPort) / Thomas Juehne (Sigma-Aldrich)
Alongside established drug target classes, innovative approaches are addressing previously undruggable target classes such as protein–protein interactions. This webinar will provide an overview of how compound profiling using the PLA® (Proximity Ligation Assay) technology can be used for in situ analysis of protein interactions by high content screening as part of the Hit-to-Lead workflow, the key advantage being the ability to provide evidence for target engagement of the compound.
Proximity ligation is a highly specific and sensitive technology to monitor individual proteins, their interactions and post-translational modifications in situ. It provides single molecule resolution and objective and unbiased quantification in cells and tissues on endogenous expression levels.
Dr. Bernhard Ellinger (Principal Scientist, European ScreeningPort) will describe how the PLA technology has been optimised for use in an automated 384-well screening format with routines for automated image analysis including spot detection, localisation and quantification. He will present a case study of a small molecule drug discovery project performed in collaboration with a biotech partner. The target mechanism involved the disruption of the interaction between amyloid ß oligomers and RAGE (Receptor for Advanced Glycation Endproducts). Profiling of compounds during Hit-to-Lead stages has involved a variety of high content functional cellular assays including PLA. He will discuss the use of PLA in 384-well format as part of a Hit-to-Lead screening cascade to monitor compound-mediated disruption of this receptor-ligand complex.
Thomas Juehne (Principal Scientist, Sigma-Aldrich) will discuss Duolink®, which is based on the in situ PLA technology, a highly sensitive and selective way of direct in cell visualisation of endogenously expressed proteins and their interacting partners enabling the use of unmodified primary cells.
The following trademarks are owned by Olink AB: Duolink® and PLA®
Michael A. Dotlich (Eli Lilly and Company) / Bei Ma (USP) / Dr. Claire Dentinger (Rigaku Raman Technologies)
During this webinar learn more about unconventional approaches to enhance quality programs with the use of modern handheld technology...
While regulatory enforcement agencies around the world have increased scrutiny on quality assurance/quality control programs, pharmaceutical manufacturers are increasingly looking for ways to lean out the manufacturing process without compromise to product quality. This push and pull conundrum has manufacturers seeking guidance on global industry regulations while searching for alternatives to legacy quality practices. With the expanding supply chain and the onset of globalization, it is now more important than ever to adjust quality programs to improve efficiency but remain keen on effectiveness for the continued promise of product quality and patient safety.
Handheld Raman technology is currently being implemented by global pharmaceutical manufacturers and regulatory agencies around the world providing an effective alternative approach to increased testing and heightened quality programs.