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Developing safe drugs by chemical and biological methods means adhering to stringent quality and regulatory requirements. Our experienced team is here to support the work you do and enable quality, safety, and compliance for every phase of the drug development workflow—from research and discovery to development and formulation, to manufacturing.
On-demand Ask the Experts sessions:
Pharmaceutical Forensics Utilizing Microspectroscopy
Duration: 28 minutes
Pharmaceutical forensics laboratories are confronted with a bewildering variety of samples for investigation. Fourier-transform infrared (FTIR) spectroscopy and FTIR Micro spectroscopy (microspectroscopy) are workhorse tools in this setting. Most FTIR work concentrates in the mid-IR range (4000-400 wavenumbers) and involves the identification of components and contaminants, determining chemical distributions and concentrations, and building reports for various stakeholders.
In this webinar, we will describe a single workstation that provides these mid/near bulk and micro analyses, which includes FT-Raman, near-IR (bulk and micro), far-IR (bulk), TGA-IR (deformulation), and even GC-IR, yielding a comprehensive pharmaceutical forensics toolbox. We will also discuss how the versatility of this workstation gives maximum flexibility, especially while operating under one software umbrella.
Presenters:
Dr. Michael Bradley taught graduate and undergraduate chemistry for 15 years before becoming a field applications scientist with Thermo Fisher Scientific. He helped develop and launch the Thermo Scientific Nicolet iN10 FTIR Microscope and the Nicolet iS10 FTIR Spectrometer. He then led the development team for the Nicolet iS50 FTIR Spectrometer and most recently the Nicolet RaptIR FTIR Microscope.
Dr. Bradley is now the Product Manager for FTIR spectrometers and microscopes. He’s involved in product development and helps teach customers to better utilize spectroscopy tools. He ensures that customer feedback is incorporated into the development of next-generation hardware and software tools. Mike also sits on the Advisory Board for Spectroscopy Magazine.
Instrument Validation and Data Regulation Solutions: IQ/OQ and 21 CFR Part 11 Compliance
Duration: 44 minutes
Compliant documentation in the drug manufacturing process is essential. 21 CFR Part 11 compliance software helps achieve this from raw materials to finished goods. In addition, the qualifications of individual instruments benefit from software-supported functionality. Learn and discuss with experts how this software can be used in the spectroscopic analysis of raw materials, the manufacture of solid oral dosage forms using twin-screw extruders, and UV-Vis methods for performing dissolution testing of tablets. We will provide a brief overview of the use and benefit of compliance software spanning various departments.
Presenters:
Suja Sukumaran, Ph.D., is a Product Manager at Thermo Fisher Scientific. She received her Ph.D. in Biophysics from Johann Wolfgang Goethe University, Germany, as part of the international Max Planck research School and is the co-inventor of US PATENTS on ‘MspA Nanopores and related methods’ licensed to Illumina Inc. She has expertise and extensive experience in molecular spectroscopy, visible and fluorescence Imaging, and protein and lipid biochemistry.Her current research interests are AI for protein folding, microplastics, and recycling.
Dirk Leister is a marketing manager for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. Together with the product line team he focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development, and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs, and efforts of their continuous process scale-up.
Lauren Ebersol has been with Thermo Fisher Scientific as a product manager supporting cuvette-based UV-Vis instruments since May 2022. She works to provide the best spectrophotometers by collecting user feedback, assessing market trends, working closely with colleagues across Thermo Fisher Scientific, and using her experience in product management. Lauren received a master’s degree in chemistry from Penn State University, where she studied protein structure and function using EPR spectroscopy.
Ask the Experts: Ensure Quality of Incoming Raw Materials: Lab-to-Field Solutions for Material Identification and Quantification
Duration: 60 minutes
Ask the Experts: Ensuring the quality of raw materials and active pharmaceutical ingredients (API) is a critical step in the drug manufacturing process with impacts on speed and cost of production, product and patient safety, and, ultimately, your brand reputation. Spectroscopy instrumentation offers many advantages including fast, accurate identification and quantification of contaminants and adulterants that can affect your product quality.
In this webinar, our panel of experts will discuss our lab-to-field spectroscopy capabilities, including FTIR, Raman, and Near Infrared (NIR) techniques, with application examples that show how you can ensure product quality as well as improve workflow efficiencies. Each presenter will provide a brief overview and an opportunity for you to get your specific questions answered.
Presenters:
Suja Sukumaran, Ph.D., is a Product Manager at Thermo Fisher Scientific. She received her Ph.D. in Biophysics from Johann Wolfgang Goethe University, Germany, as part of the international Max Planck research School and is the co-inventor of US PATENTS on ‘MspA Nanopores and related methods’ licensed to Illumina Inc. She has expertise and extensive experience in molecular spectroscopy, visible and fluorescence Imaging, and protein and lipid biochemistry.Her current research interests are AI for protein folding, microplastics, and recycling.
Sudhir Dahal is Product Manager of research Raman products at Thermo Fisher Scientific. The products include Raman microscopes and benchtop Raman spectrometers. He has worked with several spectroscopy techniques in the industry and has over 7 years of experience. He has a PhD from University of Maryland Baltimore County (UMBC), where he researched and collaborated on developing novel spectroscopy-based technique for brain tumor cell detection.
Eden Couillard is an Applications Scientist in Research and Development within the Chemical Analysis Division based in Tewksbury, Massachusetts. Since joining Thermo Fisher Scientific in 2017, she has supported new product development for several different Raman, FTIR, XRF, and LIBS handheld analyzers. Her prior experience includes large scale organic synthesis of APIs for a GMP laboratory services company. Eden holds a bachelor’s degree in chemistry from Roger Williams University and is currently working on her MBA through Southern NH University. Eden’s most recent work has been on identification of various sera products using the handheld Thermo Scientific™ TruScanRM™ and the Thermo Scientific Ramina™ Process Analyzer, a portable Raman analyzer.
In his thirty-year career at Thermo Fisher Scientific, Mike has filled many technical and management roles involving FTIR, NIR, and Raman technology. He has been instrumental in the development and marketing of routine and dedicated analyzers, software and applications used in a wide variety of industries, including pharmaceutical, polymer/chemical, food, and forensics. Mike has a strong understanding of pharmaceutical GMP and regulatory compliance requirements. In his current role as NIR Product Manager for Process Spectroscopy, he is focused on developing and marketing spectroscopy products used for routine QC analysis in laboratory, near-line and on-line in industrial production environments.
Ask the Experts: Analytical Solutions for Accelerating Drug Development in R&D
Duration: 48 minutes
Join our panel of experts to discuss analytical techniques that can help support your work in drug discovery. We offer a complete range of spectroscopy and software solutions, including FTIR, Raman, and UV-Vis, with applications that can facilitate the process of identifying and validating therapeutic targets to move forward as a potential drug candidate.
Draw on our expertise in analytical techniques to give you the edge in discovery of the next breakthrough. In this webinar, we will provide a brief overview of each analytical technique with an opportunity for you to get your specific questions answered by our experts. Topics include:
- FTIR spectroscopy has been a major partner in pharmaceutical processes, including drug development, quality assurance, and forensic investigations such as contaminant analysis or counterfeit drug investigations. Huge databases and catalogs of methods help users quickly become productive. Recent developments around microspectroscopy have improved the accessibility of the tools and the quality of the data attained, making it a workhorse tool for any pharmaceutical laboratory. Compliance tools ensure the data is useable for new drug applications, research and development, and quality control.
- Advancements in Raman technology have brought improved instrumentation, better sensitivity, excellent instrument stability over time and powerful data analysis, all with increased usability and acceptance in this field. In this webinar, we will discuss the capabilities of Raman spectroscopy in drug development for identification, including its ability to distinguish between polymorphs, characterize active pharmaceutical ingredients (APIs), and determine contaminants.
- Researchers using UV-Vis spectrophotometers measure samples as part of QA/QC process within a broader workflow, or as the final analysis to determine analyte identity or concentration. This technique is useful whether measuring large molecules in solution, small molecules in powder form, or the transparency of solids. Join us as we discuss 1) how UV-Vis spectroscopy aids in nucleic acid quantification & qualification prior to quantitative polymerase chain reaction (qPCR); and 2) how to determine the identity and concentration of ibuprofen.
Fred Fiddler currently has the role of Sr. Manager, Field Applications team for Vibrational Spectroscopy, Bulk Elemental Analysis and Material Characterization at Thermo Fisher Scientific. Fred acquired his B.S. in Pure and Applied Chemistry from the University of the West Indies Jamaica and MBA from University of Phoenix. He spent the past twenty plus years working with analytical instrumentation in roles of Applications Scientist and managing different Applications teams across a range of technologies supporting many different industries.
Dr. Michael Bradley taught graduate and undergraduate chemistry for 15 years before becoming a field applications scientist with Thermo Fisher Scientific. He helped develop and launch the Thermo Scientific Nicolet iN10 FTIR Microscope and the Nicolet iS10 FTIR Spectrometer. He then led the development team for the Nicolet iS50 FTIR Spectrometer and most recently the Nicolet RaptIR FTIR Microscope.
Dr. Bradley is now the Product Manager for FTIR spectrometers and microscopes. He’s involved in product development and helps teach customers to better utilize spectroscopy tools. He ensures that customer feedback is incorporated into the development of next-generation hardware and software tools. Mike also sits on the Advisory Board for Spectroscopy Magazine.
Sudhir Dahal is Product Manager of research Raman products at Thermo Fisher Scientific. The products include Raman microscopes and benchtop Raman spectrometers. He has worked with several spectroscopy techniques in the industry and has over 7 years of experience. He has a PhD from University of Maryland Baltimore County (UMBC), where he researched and collaborated on developing novel spectroscopy-based technique for brain tumor cell detection.
Patrick Brown is the Product Manager for NanoDrop spectrophotometers, cuvette-based spectrophotometers, and NMR instruments at Thermo Fisher Scientific. Patrick collects user feedback, integrates feedback into software and hardware updates, and works with marketing teams to communicate these benefits to end users. Thermo Fisher Scientific spectrophotometers are used by scientists around the world to quantify and qualify a variety of analytes from life science to materials science. Before joining Thermo Fisher Scientific in 2015, Patrick earned a master's degree in biomedical sciences from Pennsylvania State University.
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