Handheld Raman: Cut costs, improve efficiency & move toward 100% testing

Manage webcast
Ravi Kalyanaraman, John Kauffman & Enrique Lozano
In this one hour instructional webinar, we discuss how handheld Raman is being used to streamline the pharmaceutical manufacturing process and reduce pharmaceutical product recalls and plant shutdowns. We provide a brief overview of typical incoming raw material inspection processes and discuss how handheld Raman increases productivity and satisfies stringent cGMP requirements. We also discuss how recent developments in handheld Raman technology will continue to enable wider and faster deployment to achieve the goal of 100% testing of raw materials. Lastly, we discuss the importance of a simplified user interface for non-technical users and how advances in technology have addressed this need.
Sep 27 2012
62 mins
Handheld Raman: Cut costs, improve efficiency & move toward 100% testing
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  • Presentation 1: Jason Causon, Senior Applications Specialist, Sciex

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  • Increasing throughput and sensitivity of LC-MS assays Recorded: Jul 28 2015 63 mins
    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.
  • Biased ligands in Drug Discovery: the case of TRV027 Recorded: Jun 30 2015 27 mins
    Nicolas Pierre (Cisbio Bioassays) & William Gowen-MacDonald (Trevena)
    [UPDATE]

    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
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  • Basics of calibration and adjustment in Thermal Analysis - Useful tips and hints Recorded: Jun 5 2015 23 mins
    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 using Mass Spectrometry and NMR Recorded: May 26 2015 54 mins
    University of Dundee & Bruker Daltonics
    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.
  • The investigation of pharmaceutical substances by thermal analysis Recorded: Feb 9 2015 40 mins
    Dr. Ruedi Riesen & Santosh Dandekar
    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.
  • Practical Application of a Rapid Microbiological Method (RMM) in Pharmaceutical Recorded: Dec 16 2014 59 mins
    Scott Sutton Ph.D. and Yongqiang Zhang
    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.
  • Viability PCR - the next level in PCR-based pathogen testing Recorded: Nov 20 2014 56 mins
    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
  • How to implement NIR spectroscopy into the pharmaceutical processes Recorded: Oct 7 2014 61 mins
    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.
  • Gene editing partnerships to enhance drug pipeline productivity Recorded: Sep 25 2014 60 mins
    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.
  • Bio-Contamination, Risk Profiling and Proactive Response Recorded: Jul 10 2014 60 mins
    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.
  • Food contamination an issue? – Discover solutions for your everyday preparation Recorded: Apr 10 2014 74 mins
    Sabrina Moret (Associate Prof., Udine Uni.) / Duncan Goodwin (Director, NSF) / Susanne Feifel (Product Group Manager, Buchi)
    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.
  • Detection, quantification and visualisation of protein interactions by HCS Recorded: Apr 8 2014 59 mins
    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®
  • Pharmaceutical Manufacturing Regulations: Navigating the Complexities Recorded: Jan 30 2014 67 mins
    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.
  • Combining UPLC, QbD and Software-Guided Validation for Rapid Method Development Recorded: Dec 9 2013 64 mins
    Mia Summers (Sr. Business Development Manager, Waters Corporation)
    Method development and validation are essential parts of the pharmaceutical drug approval process. As process modifications are made and approval criteria become increasingly stringent, changes to the validated method are sometimes necessary. A Quality by Design (QbD) approach to method development uses statistical design of experiments (DoE) to generate a robust method ‘design space’. The design space defines a region in which changes to method parameters will not significantly affect the results, incorporating risk-based assessment of the final method. Rather than developing and validating a single method and proceeding through re-validation as modifications are made, a design space incorporates allowable flexibility into the method.

    A QbD approach is demonstrated here in the development of a stability-indicating method, using UPLC for fast, sensitive separations, and software-driven validation. The flexibility of transferring methods between UPLC and HPLC will also be demonstrated. This streamlined approach to method development affords considerable cost savings as well as a significantly more robust and quality submission to regulatory authorities for faster drug approval.
  • Best Practices in Managing Microbial Excursions Recorded: Dec 3 2013 57 mins
    Guenther Gapp / Tim Sandle / Dr. David Jones
    Learn from industry experts some practices to help better manage the investigation process and how to design processes to minimize unnecessary excursions.

    Microbial excursions as a result of an out of specification result from a quality control test can be time consuming and costly. The investigation of the root cause, analysis of the risk to the product, and determination of corrective/preventative actions take hours of manpower and resources and often are caused by issues around personnel practices, keying errors, and incubation errors.

    Attendees will learn:

    - What is an excursion?
    - How to identify risk in an excursion
    - Tools to help manage the process
  • RMMs for Environmental Monitoring, Validation & Viable Particle Detection Recorded: Nov 19 2013 60 mins
    Marcel Goverde PhD, Tim Russell
    There are critical performance characteristics of real-time viable particle detectors that should be considered when evaluating an instrument for your application. To help with these considerations the science behind a real-time viable particle counter and the information this technology can deliver in real-time will be presented. Applications where real-time airborne viable particle detection can provide value today in a pharmaceutical manufacturing environment will be examined. The webinar will go on to give an overview of different Rapid Microbiological Methods (RMMs) that can be used for environmental monitoring, their applicability and their pros and cons. An overview of the forthcoming revision of EP 5.1.6 Alternative Methods for Control of Microbiological Quality and the impact this will have on the validation requirements for RMMs will be presented.
  • Whatever it takes for protein analysis: Kjeldahl, Dumas, or NIR Recorded: Oct 17 2013 63 mins
    François Bourdichon, William Ickes, Giovanni Campolongo & Jürgen Müller
    A webinar focusing on the three most widely used technologies: Incoming or Outgoing goods inspections, at-line production control and quality control for declaration purposes.

    Processed food, beverage, feed or forage pass different steps in their production cycle requiring different technologies for the determination of nitrogen or protein. Whether you need fast qualification of raw material, or precise protein declaration of processed goods; Kjeldahl, Dumas and NIR solutions can be the methods to help you. There are many factors which influence the determination of the best fitting method. Whereas Kjeldahl is a proven method for all kind of sample matrices, Dumas excels in unattended processing at high throughput, and NIR is matchless in terms of immediate and comprehensive multi-component analysis. 

    This webinar will address the challenges that you are faced with in determining nitrogen or protein, and will present a range of technologies deigned to assist you in your processes.
  • Real-time monitoring: NIR as a PAT tool Recorded: Oct 8 2013 61 mins
    Dr. Volker J Frost (Metrohm NIRSystems) / Wim Guns (Metrohm NIRSystems)
    The Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives have been of interest for pharmaceutical manufacturing in the last years. Implementation of PAT/QbD approach involves monitoring and controlling critical process parameters that influence the critical quality attributes of the product. One of the prime processes in pharmaceutical solid dosage form is granulation and drying process. With the PAT and QbD initiatives, the FDA aims to increase efficiency of the pharmaceutical production by real-time process analysis and control. Near Infrared spectroscopy (NIRS) is well accepted as a potential PAT analyzer due to its rapid and nondestructive technique that additionally requires no sample preparation.

    Metrohm is well-established in determining the moisture content by Karl Fischer titration in every conceivable type of product. To provide advance solutions for pharmaceutical customers, Metrohm now is moving forward, bringing NIRS to help customers to optimize the use of raw materials and to consistently run production closer to target specifications with time- and cost-saving analytical techniques.

    During this webinar, we will be showing the use of NIR in the process that allows for monitoring low levels of residual moisture and other process constituents to yield better process control and endpoint determination. Additionally, we will be focusing on:
    •Developing robust and precise method
    •Minimizing implementation efforts
    •Ensuring calibration model transferability between analyzers.
  • Advantages of Handheld Raman in the Pharmaceutical Industry Recorded: Sep 24 2013 55 mins
    Dr. Katherine A. Bakeev (B&W Tek) / Sulaf Assi (Bournemouth University)
    Benefits and applications of handheld Raman and how it can help to facilitate compliance with PIC/S..

    This webcast will discuss the benefits and applications of handheld Raman, including the reasons the industry is interested in the technology, data integrity, method development, how samples are scanned, and challenges that have been conquered. We’ll also discuss PIC/S and how it is unifying the regulatory perspective globally, currently including 41 member countries with applications of Japan and Korea under review. We’ll discuss how these regulations are moving towards 100% container testing globally and how handheld Raman technology can help to achieve it, as well as the importance of validation of instrumentation and methodologies.
  • Metabolite Identification in the Real World Recorded: Jul 11 2013 62 mins
    Dr. Axel Pähler (Hoffman La-Roche) / Marieke Teppner (Hoffman La-Roche) / Vicki Gallant (AB Sciex)
    Three industry leads present strategies and tools for Metabolite Identification...
Webinars for the pharmaceutical, food & beverage industries
Hear the leading industry experts talk about the important pharmaceutical, food & beverage manufacturing topics.

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  • Title: Handheld Raman: Cut costs, improve efficiency & move toward 100% testing
  • Live at: Sep 27 2012 2:00 pm
  • Presented by: Ravi Kalyanaraman, John Kauffman & Enrique Lozano
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