Agilent

Articles

This application note demonstrates that the Agilent 6475 
triple quadrupole LC/MS system can confidently quantify 
nitrosamine impurities at the low concentration levels 
specified by regulatory requirements. This method can 
be used to quantify these impurities in different ARB drug 
products, with some changes in chromatographic conditions 
based on the elution pattern of the drug product.

Determination of Eight Nitrosamine Impurities

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!

https://www.spectroscopyonline.com/spec/a-workflow-approach

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.



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

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.


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.




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.




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.




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.




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.



Webcasts

Webinar Date/Time: Thu, Feb 23, 2023 11:00 AM EST

Tools for the Pharma QA/QC: A Workflow Approach

Extractables and Leachables Testing: Navigating Regulatory Changes

https://www.spectroscopyonline.com/spec_w/trs100

The Agilent TRS100 Raman system is ideal for fast assay of tablets, capsules, and other dosage forms. Transmission Raman technology from Agilent enables simple method-development and deployment in QC applications. It is easy to implement in analytical laboratories and production areas, and has regulatory approvals for content uniformity (CU), assay, and identification (ID) applications

How TRS100 can improve the operational efficiency of solid dose analysis in the QC Lab

TRS workflows for quantitative tablet and capsule analysis

TRS revolutionizes content uniformity testing that avoid all sample preparation, achieving results in less than 15 minutes.

TRS can be used for R&D formulation development and crystallinity application with low ~1%w/w LOD

Key value drivers for implementation of spectroscopy, cost saving resource saving and sustainability drivers can be achieved with this technology.

Pharma QC scientists, laboratory managers


Transmission Raman Product Manager
Agilent Technologies, Inc.


Julia Griffen (PhD in Chemistry, University of Bath) is currently the Product manager for the Agilent’s Transmission Raman product. Julia has worked in the field of Raman Spectroscopy for over 8 years where she started her career as an applications scientist for Cobalt light Systems. In this time Julia has built an excellent knowledge of the technology, published peer reviewed articles, and considered and expert of the technology.

Thursday, ​​​​July 21st, 2022 at 11am EDT|8am PDT|4pm BST|5pm CEST

Learn about the use of molecular spectroscopy techniques – transmission Raman spectroscopy (TRS) and laser direct infrared (LDIR) – for solid-state analysis in pharmaceutical formulation development.

 

Allowing You to do More with Less: The TRS100 Transmission Raman System

https://www.chromatographyonline.com/lcgc_w/azido

Several sartan, ranitidine, and metformin-based drug products have been recalled due to nitrosamine contamination, in unacceptable amounts, in these drugs. Since then, there has been increased scrutiny by the regulators to accurately identify and quantify mutagenic impurities in drug substances and products. The US FDA and other regulatory agencies have published analytical testing guidance documents regarding the evaluation of mutagenic nitrosamine impurities in these drug substances and drug products. Recently, sartan therapeutics were again recalled due to another known mutagenic impurity called 

. Additionally, there have been recalls related to nitroso impurity in varenicline drug products.

This presentation will address the accurate determination of mutagenic azido impurities, nitroso drug substance related impurities (NDSRIs) and nitrosamine impurities in drug substances and products using liquid chromagraphy–tandem mass spectrometry (LC–MS/MS) based analytical strategies that you can adopt to meet your nitrosamine detection and quantitation needs.

Understand what mutagenic impurities are and the importance of characterizing and quantifying them

Learn about approaches for the confident identification and quantification of nitroso drug substance related impurities (NDSRIs) and nitrosamine impurities in APIs and drugs

Learn about approaches for the confident identification and quantification of azido impurities in five different sartan therapeutics



Application Engineer
Agilent Technologies


Kartheek Srinivas Chidella has more than 13 years of experience in the pharmaceutical and analytical industry working on LC–MS/MS. After completing his M.Sc. (Organic Chemistry) at Andhra University, Kartheek started his career at Dr. Reddys Laboratories in Analytical & Bioanalytical department and developed several LC–MS/MS methods for determination in drugs in biological matrices. He later joined Mylan Laboratories in analytical development and worked on impurity profiling applications using LC–MS/MS. He later joined Waters as an LC–MS technical and application support specialist and now in his current role as application engineer in Agilent, he is actively involved in providing application support for genotoxic impurity applications using LC–MS/MS.

Thursday, July 14th, 2022 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST Join us to learn approaches for the accurate determination of mutagenic azido, NDSRI, and nitrosamine impurities in drug substances and products using LC–MS/MS.

Accurate Determination of Mutagenic Azido, NDSRI, and Nitrosamine Impurities in Drug Substances and Products Using LC–MS/MS

https://www.spectroscopyonline.com/spec_w/transmission_ram

When considering a new analytical technology in the pharmaceutical industry, two key questions always arise: is there a good business case for it, and what are the regulatory consequences? In this talk, we will present the approach that led to the implementation of transmission Raman spectroscopy for content uniformity testing at a pharmaceutical company. We will show that it is not only the financial benefit, but also the stakeholder enthusiasm that convinced management of the need to invest in new technology for a standard test requirement.

The approach for rolling out transmission Raman spectroscopy to all sites at Grünenthal Pharma involves the development of procedures and templates steered by a Center of Expertise (COE). In the COE the models developed and the standard approach for sample preparation—including required equipment— is determined alongside the validation procedure. The regulatory strategy, including templates, is also determined here. With this approach, Grünenthal Pharma intends to ensure a global standard and enable the ability to support and transfer methods from one site to all others.

The reasons for using transmission Raman spectroscopy for content uniformity and how it works in conjunction with established liquid chromatography (LC) methods.

The approach that led to the implementation of transmission Raman systems for content uniformity testing at Grünenthal Pharma.

How roll-out of these new systems relies on a Center of Expertise for model development, sample preparation, validation procedures, and regulatory strategy.

How the company intends to ensure a global transferable standard in content uniformity testing using transmission Raman spectroscopy

Biopharma and Pharma professionals working in the areas of:


Manager Process Analytical Technology
Grünenthal Pharma, Germany


Meike has a background in Pharmacy and has a Ph.D from the University of Helsinki, which focused on the physical properties of solid dosage forms during pharmaceutical processing, specializing in multivariate data analysis and spectroscopic methods. She then spent four years at the University of Münster, in the Division of Pharmaceutical Technology, followed by project management roles in Galenical development with Rottendorf Pharma and Corden Pharma. Since 2016 Meike has been a Process Analytical Technology Manager at Grünenthal Pharma, focused on establishing transmission Raman in Quality Control.


Head of Pharma Business, Raman Spectroscopy
Agilent Technologies


Darren has a background in Chemistry and Physical Chemistry with a degree in the former and a Ph.D in the latter, which focused on short pulse laser spectroscopy. He joined Unilever from university, working in the research and product development divisions in Port Sunlight, UK, and in Utsunomiya, Japan. He left there to work in the Science and Technology Facilities Council in IP and business development before spinning off Cobalt Light Systems with the inventor of the technology used in the RapID instrument. Since the company was acquired by Agilent in 2017 Darren has become the Head of Pharma at the new Raman division, based out of Oxford in the UK.

Tuesday, July 12th, 2022 at 11am EDT|8am PDT|4pm BST|5pm CEST

Dr. Meike Römer from Grünenthal Pharma, Germany, presents the company’s approach for the evaluation and implementation of transmission Raman spectroscopy for pharmaceutical content uniformity testing.
 