Tools for the Pharma QA/QC: A Workflow Approach

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:

• Understand how transmission Raman spectroscopy can be used in drug discovery and development workflows
• Learn how to optimize dissolution testing
• Explore the use of Agilent’s FTIR and spatially offset Raman spectrometers (SORS) for raw materials identification (RMID)
• The application of on-line HPLC to monitor and control CQA in bioprocessing

Symposium Who Should Attend:

• R&D scientists
• QC scientists
• Lab managers
• Formulation development scientist
• Analytical scientists
• Department/group leads

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