Webinar Date/Time: Thu, Feb 23, 2023 11:00 AM EST
Join this symposium to how to optimize dissolution testing, understand how transmission Raman spectroscopy can be used in drug discovery and development workflows, and more!
Register Free: https://www.spectroscopyonline.com/spec/a-workflow-approach
Event Overview:
Spectroscopy and chromatography play key roles in the workflows of pharmaceutical and bioprocessing QA/QC labs. Understanding the importance of these tools in raw materials identification, content uniformity, and other workflows provides critical quality attributes (CQA) in a regulated environment. High-performance liquid chromatography (HPLC) is a proven tool for the analysis of critical process parameters (CPP) of biotherapeutics.
Symposium Key Learning Objectives:
Symposium Who Should Attend:
Full Agenda:
Optimizing Dissolution Testing
Ken Boda, Dissolution Specialist, Agilent
Dissolution is a key test to ensure that a drug is safe and effective and is the only test that can assess a formulation’s performance. To have meaningful dissolution data, it is critical to ensure reproducibility of the dissolution apparatus and procedures. We will discuss optimizing the dissolution to bring about greater accuracy and precision, fewer dissolution failure investigations, and achieving higher throughput.
Optimizing Dissolution Testing Integration of On-line HPLC as a PAT Tool for CQA Monitoring and Control in Bioprocessing
Stacy Shollenberger, Senior Marketing Manager, Process Analytical Technologies, Millipore Sigma & Daniel Kutscher, Product manager, Strategic Marketing, Agilent Technologies
High-performance liquid chromatography (HPLC) is a proven tool for the analysis of critical process parameters (CPP) and critical quality attributes (CQA) of biotherapeutics. Historically, HPLC has been performed off-line—a process that can take days or weeks to complete. By moving HPLC to the manufacturing floor as an on-line process analytical technology (PAT) tool, relevant data can be accessed in a matter of minutes. In this webinar, we highlight an initial use case demonstrating the utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.
Raw Material Identification and Verification in Compliant Environments with FTIR and Raman Spectroscopy
Yanqia Wang, Application Engineer, Molecular Spectroscopy, Agilent Technologies
Raw material identification (RMID) or verification is a common QA-QC practice in complaint environments with tremendous impact on customer safety as well as speed and cost of production. RMID has become an important application field of FTIR and Raman spectroscopy. Today’s RMID can occur either in the field and in-lab, which raise new challenges. Agilent’s compact portable FTIR and spatially offset Raman spectrometers (SORS) provide a great combination with versatile sampling interfaces and spectral process capabilities, which can offer great convenience, stability, and high-throughput solution to the RMID applications in compliant environments.
Embracing the UV-Vis QA/QC Needs of a Pharma/BioPharma Laboratory
Mark Fisher, Application Engineer, Molecular Spectroscopy, Agilent Technologies
The UV-Vis QA/QC needs of a pharma/biopharma laboratory range from the simple (an absorbance measurement at a single wavelength) to the complex (a thermal melt, also known as an absorbance verses temperature measurement). One of the challenges for a lab is deciding between a measurement-specific instrument or an instrument designed to perform a variety of measurements equally well. Agilent has two UV-Vis spectrophotometers that provide the pharma/biopharma the flexibility to meet their current and future needs even in a compliant environment.
Speakers
Ken Boda
Dissolution Product Specialist
Agilent Technologies
Ken joined Varian (now Agilent) in 2005 as an applications engineer and is now a dissolution product specialist. Prior to working at Agilent, he worked in pharma, specializing in dissolution testing and method development. As a dissolution product specialist, Ken works with customers in determining the best systems for their needs and optimizing their workflows. He has also helped educate customers on dissolution science through webinars, the Dissolution Discussion Group, LinkedIn, and other channels.
Stacy Shollenberger
Senior Marketing Manager, Process Analytical Technologies
Millipore Sigma
Stacy Shollenberger holds an MS degree in biochemistry from the University of Virginia and an MBA from Penn State University. She has over 12 years of experience in analytical and bioanalytical product and method development. Currently, Stacy is a senior manager of process analytical technologies (PAT) at MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, and is responsible for defining the PAT strategy to move testing from traditional off-line quality control (QC) to QC on the bioprocessing floor.
Daniel Kutscher
Product Manager, Strategic Marketing
Agilent Technologies
Dr. Daniel Kutscher is a biochemist and experienced life-science professional with global responsibilities as a product manager for analytical HPLC. Daniel received his Ph.D. in 2011 from Justus-Liebig-University in Giessen, Germany under the supervision of Prof. Alfred Pingoud. After completing his Ph.D., he moved to New York and worked until 2018 as an HPLC product specialist, supporting customers in various industries. Daniel currently works for Agilent Technologies as a product manager - strategic marketing with a strong focus on better connecting the analytical with the (bio-) process world.
Yanqia Wang
Application Engineer, Molecular Spectroscopy
Agilent Technologies
Dr. Yanqia Wang started working for Agilent Technologies Inc. as an FTIR application engineer in 2013, providing pre- and post-sale application support. The products he covers from benchtop FTIR microscopes to various mobile FTIR spectrometers. Dr. Wang received his Ph.D. of analytical chemistry from Duke University in 2004, doing dynamic IR spectroscopy research. Then he joined Fitzpatrick Center for Photonics at Duke University, doing tissue Raman spectrometer instrumentation. Since 2007, Dr. Wang worked for Avery Dennison Corp. as a spectroscopist, providing molecular analytical support to the research and development.
Mark Fisher
Application Engineer, Molecular Spectroscopy
Agilent Technologies
Mark Fisher graduated from the University of Nebraska-Lincoln in 1982 with a Doctorate in Chemistry with an emphasis in analytical chemistry. He has been with Agilent for 29 years. His duties include pre-sales support functions such as application support, demonstrating spectrophotometers and accessories, and training of sales force.
Register Free: https://www.spectroscopyonline.com/spec/a-workflow-approach
Portable and Wearable Spectrometers in Our Future
December 3rd 2024The following is a summary of selected articles published recently in Spectroscopy on the subject of handheld, portable, and wearable spectrometers representing a variety of analytical techniques and applications. Here we take a closer look at the ever shrinking world of spectroscopy devices and how they are used. As spectrometers progress from bulky lab instruments to compact, portable, and even wearable devices, the future of spectroscopy is transforming dramatically. These advancements enable real-time, on-site analysis across diverse industries, from healthcare to environmental monitoring. This summary article explores cutting-edge developments in miniaturized spectrometers and their expanding range of practical applications.
Using Raman Spectroscopy and Surface-enhanced Raman Spectroscopy to Detect Cholesterol Disorders
November 25th 2024Researchers have developed a highly sensitive method using Raman and surface-enhanced Raman spectroscopy (SERS) with gold nanoparticles to accurately quantify intracellular cholesterol.
Nanometer-Scale Studies Using Tip Enhanced Raman Spectroscopy
February 8th 2013Volker Deckert, the winner of the 2013 Charles Mann Award, is advancing the use of tip enhanced Raman spectroscopy (TERS) to push the lateral resolution of vibrational spectroscopy well below the Abbe limit, to achieve single-molecule sensitivity. Because the tip can be moved with sub-nanometer precision, structural information with unmatched spatial resolution can be achieved without the need of specific labels.