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

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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Medical Research

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    There is a great interest in application of human mesenchymal stem cells (hMSCs) in cell therapy and tissue engineering due to their self-renewal, multi-lineage differentiation, immunomodulation, and trophic potential. One of the challenges faced in the clinical application of hMSCs is the need for efficient expansion of these cells in vitro without altering their capacity. Serum-free mammalian cell culture media, in particular, require optimization of the expansion protocols. Even subtle changes in routine handling can have a significant impact on the cells’ potential.

    This seminar will cover the variables that can influence the desired regenerative and differentiation properties including medium selection, vessel surface treatment, impact of the cell source, and seeding density. We will also discuss how users can select the correct conditions for optimized growth and functionality.

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  • This webinar will discuss the evolving role of Cell Lines and Cell Culture and their usefulness as models of physiological function and disease. The webinar will review the depth, breadth and best use of currently available Cell Lines. The role played by Cell Lines in ensuring that the output of future research continues to be valid and credible will also be evaluated. This is the first of a three part webinar series focused on delivering a broad picture of the role of cell lines as models in scientific research, the various strategies and approaches available.
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  • Today use of the term “single use technologies” can be considered as being synonymous with the modern biotech industries. Based on the proliferation of companies now specialising in providing solutions to pretty much anyone anywhere, along with the intensive level of marketing and industry discussion, it is clear to see that the sector has progressed significantly over the years. The ability to purchase systems and technologies off the shelf as a consumable, rather than invest in significant capital infrastructure, better facilitates small enterprises to perform small and pilot GMP scale manufacture in-house. Organisations are able to leverage the experience of the manufacturers in the development of these products. The concept of single use technologies has been proven to produce solutions which are compliant and work. However, there still are questions around regulatory guidance for single use technologies.
  • Within the development of rapid screening methods to secure the global supply chain, the FDA’s Division of Pharmaceutical Analysis (DPA) has been building Raman spectral libraries for verification of pharmaceutical materials, in conjunction with handheld instruments in the field. Focusing on finished products, we evaluate the spectral library for method specificity, showing high specificity for drugs containing different active ingredients.
  • Visit this page to download our infographic:
    http://www.vitaminsinmotion.com/fileadmin/data/images/infographics/Eat_right_for_your_sight_Digital_06.pdf

    The global market for eye health ingredients is increasing fast with a projected compound growth rate of 5.9% until 2019 [1]. The innovation is no longer focusing only on age-related macular degeneration. Supplementation can be beneficial to healthy people of all ages to achieve optimized visual performance and comfort.

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    [1] Frost&Sullivan (2013). “Strategic Analysis of the Global Eye Health Ingredients Market”.
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  • 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
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    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...
  • From a Paper-based Trial Master File to a Streamlined Electronic Document... Recorded: Jun 11 2013 61 mins
    Patricia Brady (Snr. International Clinical Trial Manager, Sanofi) / Guillaume Gerard (Enterprise Program Director, NextDocs)
    Webinar on the transformation of a Paper-based Trial Master File to a Streamline Electronic Document Management Solution. At Sanofi, managing clinical drug trials was primarily a paper-based process. The logistics of managing this paper-based process for dozens of concurrent trials was daunting, expensive, and time consuming. The company wanted to optimize this manual process with a streamlined digital signature-compliant document management solution operating in a global, web-based collaborative framework. To do this, Sanofi implemented a clinical trial portal, which is based on Microsoft SharePoint portal and collaboration technologies.
  • Validating a Rapid Method for Pharmaceutical Applications Recorded: May 16 2013 59 mins
    Dr. Michael Miller (Microbiology Consultants, LLC) / Silvia Fragoeiro (Merck) / Juan Gonzalez-Garzon (BD)
    Validation of rapid methods continues to be an obstacle to greater adoption of these technologies. Some of the benefits of rapid methods are well articulated across industry literature, including the ability to release products much faster as well as intervene faster in the event of contamination in any part of the manufacturing process. Regulatory approval and the challenge of actually validating the rapid method for many applications continue to be viewed as stumbling blocks.
  • Leveraging cutting-edge Rapid Microbiological Methods... Recorded: Mar 21 2013 54 mins
    Jeffrey Weber (Pfizer) / Allison Scott, Ph.D. (Azbil BioVigilant, Inc.) / James Drinkwater (Chairman, PHSS)
    Focused on Rapid Microbiological Methods (RMMs), this one hour webinar will deliver information and insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage.

    A combination of knowledgeable suppliers, a competitive market, motivated end users, and encouragement from regulatory bodies has placed a number of companies at the forefront of the race to implement an instantaneous and continuous rapid microbiological method (RMM) in their pharmaceutical manufacturing environment.

    A number of rapid microbiological methods have emerged, and various degrees of testing have been performed by RMM system suppliers and their end users to determine how such systems may be beneficial to and implemented in an environment where traditional monitoring methods have been utilized for over 100 years.
  • Accelerating and Automated Rapid Microbial Testing Recorded: Nov 14 2012 64 mins
    Christof Hasse / Anna Mills / David Jones
    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
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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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