Agilent

Articles

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.

Webcasts

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. 

Extractables and Leachables: Trends and Future Directions Part II A roundtable discussion

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

Are you planning to turn your analytical HPLC method into a purification method? Are you converting your analytical-scale purification method to semi-prep or production scale? No matter what scale of preparative chromatography you are trying to tackle, knowing where to start and how to scale up are essential to your success. Learn how to set appropriate purification goals for purity, yield, and throughput and what type of equipment will best fit your application. This webinar will discuss:

Setting objectives for preparative HPLC Separations

Analytical-scale prep, semi-prep, prep? What is the right fit for my application?

What is the difference in efficiency between a single injection vs. batch processing to separate large quantities?

What are the calculations for scale-up from analytical to prep and is there a shortcut that works?

How can I pack my own columns? What is the benefit of self-packing columns?

Learn how to scale up from analytical HPLC methods to larger scale preparative HPLC.

Understand purification terminology and how to set goals regarding purity vs. yield vs. throughput

Learn to use a scale up calculator to enable choices of column dimension and/or appropriate equipment configuration

Lab Managers, Research Scientists, Lab Technicians

Lori Sandford is an HPLC Applications Scientist with Agilent Technologies, Inc. in Wood Dale, IL. Lori has been working at Agilent Technologies supporting HPLC instrumentation since 2010. Prior to Agilent, she was the Global Technology Manager for Prep and Process Chromatography at W. R. Grace/Alltech. Her career started at G.D. Searle/Pfizer in 1998 as a chromatography specialist in the Prep and Process Chromatography group supporting both medicinal and process separations. When she isn’t tinkering with an HPLC instrument in the lab, you’ll find her watching her kids play ice hockey and dabbling on the ice herself. A favorite new hobby is nurturing some sourdough starter and learning to bake bread.

Gina Black joined Agilent over 3 years ago and brought with her a wealth of experience in the pharmaceutical industry.She began her career at Merck as a synthetic chemist and became a subject matter expert in preparative HPLC, eventually joining the Separations Center of Excellence (COE), supporting both discovery and process development efforts.After twenty-two years at Merck, Gina moved to Bristol-Myers Squibb where she served as a site lead for their Single Compound Purification group, using a highly automated workflow to analyze, purify, and deliver final products for biological testing.Gina then moved back into large scale separations and enabling technologies supporting Chemical Development at BMS.Over the years, Gina has developed an extensive background in both reversed-phase and normal-phase HPLC, SFC, and IEX methodologies.

Tuesday, October 26, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Are you planning to turn your analytical HPLC method into a purification method? Are you converting your analytical-scale purification method to semi-prep or production scale? Learn how to set appropriate purification goals for purity, yield and throughput and what type of equipment will best fit your application.

Analytical-Scale Prep, Semi-Prep, Process Scale Preparative Chromatography: To Infinity and Beyond!

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

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. These studies pointed to concerns regarding the way E&L was 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 into the future.

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

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

Researchers interested in E&L testing in Food/Pharma/Medical Device/Consumer Products/Polymer Manufacturing/CRO’s/CMO’s and other

Dr. Mark Jordi is the President of Jordi Labs, a position he has held since 2006. During his tenure, Jordi labs has experienced 15 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 B.S. in chemistry at Olivet Nazarene University and his Ph.D. 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.


Ted Heise supports regulatory and clinical study strategies for MED Institute clients. His B.S. in chemistry is from the University of Nebraska, and his Ph.D. 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. He is also currently serving as the convenor of the working group for ISO 10993-18 on chemical characterization.

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 the convener of ISO TC194 WG11, which is responsible for the development and revision of the ISO 10993-17 standard.

Tuesday, September 28, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

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 may take into the future. 

Extractables and Leachables: Trends and Future Directions A roundtable discussion

http://www.pharmtech.com/pt_w/solid_state

Transmission Raman Spectroscopy (TRS) is licensed in the pharmaceutical industry for the identification and determination of bulk assay and uniformity of content of finished products. The first part of this webcast will cover the basic principles of Raman spectroscopy, discussing the advantages and limitations over conventional testing methods, the process steps required to select suitable products for Raman testing, and the development and validation requirements of Raman methods and models. This presentation will also review regulatory submissions of Raman methods and the lifecycle maintenance of licensed Raman models. The second part of this webcast will describe how LDIR technology can enable rapid, high-quality surface imaging of large tablet surfaces, for applications including polymorph screening in the formulation.

Advantages and limitations of Raman Spectroscopy over conventional methods for content uniformity testing

Development of Raman models for bulk assay and UoC testing

Rapid, high quality surface imaging of large tablet surfaces, for applications including polymorph screening in formulation development using LDIR technology

Zoe Betteridge, R&D Senior Scientist, Accord UK

Darren Robey, Global Product Manager – IR Imaging, Agilent Technologies, Inc.

US & Europe: Tuesday Sept. 29, 2020 at 9am EDT | 2pm BST | 3pm CEST

US: Tuesday Sept.  29, 2020 at 4pm EDT | 3pm CDT | 1pm PDT

Asia Pacific: Wednesday, Sept. 30, 2020 at 10:30am IST | 1pm CST | 2pm JST | 3pm AEST

On demand available after airing until Sept. 30, 2021

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.
Live: 
US & Europe: Tuesday Sept. 29, 2020 at 9am EDT | 2pm BST | 3pm CEST, 
US: Tuesday Sept.  29, 2020 at 4pm EDT | 3pm CDT | 1pm PDT, 
Asia Pacific: Wednesday, Sept. 30, 2020 at 10:30am IST | 1pm CST | 2pm JST | 3pm AEST

On demand available after airing until Sept. 30, 2021

Solid State Analysis in Pharmaceutical Formulation Development: Advantages and Limitations of Transmission Raman and LDIR Chemical Imaging techniques

http://www.spectroscopyonline.com/spec_w/raw_materials

This webcast will describe raw material verification testing through transparent and non-transparent packaging using the new Agilent Vaya Raman system.

Vaya is the first handheld Raman spectrometer incorporating spatially offset Raman spectroscopy (SORS) technology for the quick identification of raw materials through containers. SORS reduces the need for sampling, saving cost and resources by testing incoming goods quickly in the warehouse. Vaya combines the capabilities of conventional Raman systems with SORS for maximum sample/container compatibility. This webinar will also cover the transformative implementation of Vaya in a warehouse and use it in a cGMP environment, sharing the financial impact of the handheld SORS system for manufacturing operations.

Raw material identity verification through transparent and non-transparent containers removes the need for sampling, increasing testing throughput without increasing costs

The new handheld Vaya system, with true through-barrier SORS technology, works through most common containers - from clear glass vials to multilayer paper sack

Vaya improves current testing protocols—from low volume sampling to 100% ID testing

How to streamline an identification process with Vaya

How much cost can be reduced through the deployment of Vaya for Raw material Identification?

Compliance support on Vaya: 21 CFR Part 11, USP (<1120>, <1858>, <858>, <1225>) and EP 2.2.48, CP and JP

Frederic Prulliere, Raman ID Product Manager, Agilent Technologies

US & Europe Broadcast: Thursday, Oct. 1, 2020 at 9am EDT| 2pm BST| 3pm CEST

US Broadcast: Thursday, Oct. 1, 2020 at 4pm EDT | 3pm CDT| 1pm PDT

Asia Pacific: Friday, Oct. 2, 2020 at 10:30am IST| 1pm CST| 2pm JST| 3pm AEST

On demand available after airing until Oct. 2, 2021

This webinar will describe raw material verification testing through transparent and non-transparent packaging using the new Agilent Vaya handheld Raman system. True through-barrier analysis removes the need for sampling, increasing testing throughput without increasing costs—from clear glass vials to multilayer paper sacks.

Live: 
US & Europe Broadcast: Thursday, Oct.1, 2020 at 9am EDT| 2pm BST| 3pm CEST,
US Broadcast: Thursday, Oct. 1, 2020 at 4pm EDT | 3pm CDT| 1pm PDT,
Asia Pacific: Friday, Oct. 2, 2020 at 10:30am IST| 1pm CST| 2pm JST| 3pm AEST

On demand available after airing until Oct. 2, 2021