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The Chromatography & Mass Spectrometry Division and the Clinical Research Business (which includes PPD® Laboratory services) of Thermo Fisher Scientific will host side-by-side booths and conference talks during Extractables & Leachables USA in Arlington, Virginia, April 5-7. This will be the first time the two groups will jointly present Thermo Fisher’s differentiated end-to-end solutions for extractable and leachable (E&L) analysis.

 

Thermo Fisher will cover the execution of E&L studies across the various stages of pharmaceutical development. By combining the company’s advanced laboratory services for planning and executing E&L studies with innovative chromatographic, mass spectrometry instrumentation and software solutions, Thermo Fisher can accelerate promising medicines from early development through regulatory and market approval.

 

For those who may be newer to E&L, here is a brief recap.

 

What are "extractables?"

 

 

To study the risk of materials, extraction studies are performed, generally using aggressive solvent conditions including acidic, basic, organic and aqueous solvents and Soxhlet or accelerated solvent extraction.

 

It is important that the extraction process does not deform the material of interest. Compounds present in the resulting extracts are called "extractables." Extractables studies are typically performed to create a "worst-case scenario" and assist in materials selection and early risk assessment.

 

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What are "leachables?"

 

Leachables are chemical species that make their way into the product under normal product, application or storage conditions.

 

There is generally an overlap such that the leachables involved may be classified as a subset of the extractables. Forced or accelerated leachable studies can be performed to assess leachables that migrate under simulated environmental conditions by analyzing the drug formulation after exposure to elevated temperature.

 

However, if the leachable interacts with the drug product or packaging materials, new components can be present. These are termed secondary leachables. Drug formulations often contain buffers, surfactants, fillers, and other excipients. This complexity means there sometimes are secondary leachables that only can be identified after long stability studies over the typical drug shelf life.

 

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Why is it important to monitor for extractables and leachables?

 

Accurate identification of E&L compounds is vital to ensure that products we consume or use are safe. It also safeguards that there are no potentially harmful chemicals being absorbed into a finished drug product, medical device, or food contact material when it is manufactured, packaged or stored.

 

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So, what are Thermo Fisher’s differentiators in the field of E&L? And where can I find more information?

 

Thermo Fisher Scientific offers differentiated solutions for extractable and leachable analysis from ultra-inert MS certified consumables, chromatographic systems that can boost sample throughput and detectors that detect the seemingly undetectable.

 

The company’s ultra-high resolution mass spectrometry systems allow confident identification of unknowns, especially when used in combination with extensive E&L high-resolution accurate mass libraries (HRAM), such as m/z cloud (which is free to use). Automated software workflows make identifying extractables quicker and easier without the need to do extensive manual data interrogation. The company also offers a dedicated eLearning Center.

 

PPD Laboratory services’ GMP Lab has been designing and conducting E&L studies for more than 20 years. Its extensive breadth and depth of experience have helped dozens of clients meet regulatory requirements. The large E&L dedicated teams in Middleton, Wisconsin, and Athlone, Ireland, work together seamlessly to customize E&L programs for global drug development programs of all sizes.

 

Looking for additional resources on E&L analysis? Visit here.

 

Extractables and Leachables USA

April 5 - April 7, 2022
Arlington, Virginia & Online

 

At E&L USA Thermo Fisher Scientific will host two plenary talks by experienced E&L scientists. Benton Cartledge, Ph.D. Research Scientist, PPD Laboratory services, will present “Understanding Extractables Profiles Based on the Polymerization Chemistry of Different Materials.” This presentation will focus on butyl rubber, silicone rubber, PET, PBT and polycarbonate. The goal of the presentation will be to provide typical extractables observed from these materials and explain why/how they are formed from the polymerization process.

 

In addition, Chris Shevlin, Scientific and Educational Affairs Manager, Thermo Fisher Scientific, will present “Identification of Polymer Additives Extracted from Single-use Bioreactor Bags.” This workflow has the benefits of sample preparation automation using accelerated solvent extraction and LC HRMS, which can significantly increase sample throughput compared to traditional techniques such as reflux or Soxhlet extraction.

 

Both are trending topics in the field of E&L and should make for fruitful discussions.

 

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