Agilent

Articles

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.

Webcasts

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.
 

Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method

New Hand-Held Raman Spectrometer Enables Identification of Raw Materials Containers in Pharmaceutical Warehouses

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

The characterization of extractables and leachables is important for ensuring product safety for both drugs and medical devices. In the last few years, the issuance of the ISO 10993-18:2020 medical device guidance and several high-profile publications and round robin studies have resulted in the FDA increasing scrutiny of E&L analyses. Of particular interest is a review paper published very recently by scientists in the device center of FDA. These sources highlight important gaps in the way E&L studies are typically conducted. The complexity of these changes has been increased by the fact that the best practices and regulatory requirements for drugs and medical devices are different but not always appreciated. This roundtable discussion will provide an open forum for discussing these changes and for exploring current best practices. The panelists will also discuss the regulatory trends they see for E&L studies in the future.

What are the key differences between drug and device E&L studies?

What changes have occurred in the field of E&L testing over the last 2 years?

What does the future look like for E&L studies and what questions remain to be answered?

Researchers interested in E&L testing in Food/Pharma/Medical Device/Consumer Products/Polymer Manufacturing/CROs/CMOs and other

Analysts performing untargeted analyses including drug impurity profiling

Quality Assurance experts in the above industries

Dr. Mark Jordi is the President of Jordi Labs, a position he has held since 2006. During his tenure, Jordi labs has experienced 16 years of consecutive growth and has become a leader in the polymer analysis industry. Jordi Labs provides over 2,000 analyses annually and offers more than 60 analytical techniques serving a wide range of industries including the chemical, pharmaceutical, and medical device industries. Dr. Jordi completed his BS in chemistry at Olivet Nazarene University and his PhD at the University of Connecticut in the materials science division. His primary interests include development of improved strategies for identification and quantification of extractables and leachables as well as chromatographic and mass spectrometric analysis. Dr. Jordi is also an inventor and has developed a number of novel chromatographic stationary phases, some of which are patented.


VP Regulatory and Clinical Services
Med Institute

Ted Heise supports regulatory and clinical study strategies for Med Institute clients. His BS in chemistry is from the University of Nebraska, and his PhD in analytical chemistry is from Iowa State University. Dr. Heise is an expert in ISO and USP committees for consensus standards that govern biocompatibility testing of medical devices and drug packaging, currently serving as convenor of the working group for ISO 10993-18 on chemical characterization.


Director and Principal Toxicologist
Risk Science Consortium

Ron Brown is a toxicologist who recently retired from the US FDA and currently directs a small company, Risk Science Consortium, LLC. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds released from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations, notably, as convener of ISO TC194 WG11, which is responsible for the development and revision of the ISO 10993-17 standard.

Wednesday, May 25, 2022 at 11am EDT|8am PDT|5pm CEST|4pm BST

In the last few years, the issuance of the ISO 10993-18:2020 medical device guidance and several high-profile publications and round robin studies have resulted in the FDA increasing scrutiny of E&L analyses for both drugs and devices. Join our panel of industry experts to discuss these changes and to learn the direction E&L studies may take in the future. 