extractables and leachablesOn a molecular level, over time plastics offer as much resistance to migration as a Schengen border. As plastics age, their properties can change, and some molecules can readily migrate or ‘leach’ from and through plastics.

Can Plastics Leach Toxic Compounds?

The stories about plastic food containers causing contamination of foodstuffs with toxic compounds are well known, such as that of Bisphenol-A, discussed in this great blog from Paul Dewsbury. Well, the same goes for plastics used in the storage and production of pharmaceuticals and biopharmaceuticals. The study of migration of contaminants from pharmaceutical production or container-closure systems is called extractables and leachables testing. The testing tries to identify, quantify and monitor unknown chemicals that leach into drug production vessels or into the final drug formulation and pose a risk to patient health or drug product quality. As with food packaging, there are also several high profile examples where potentially toxic chemicals have leached from pharmaceutical packaging into the drug product, resulting in costly product recalls.

What are Extractables and Leachables?

Click on the thumbnail image below to enlarge and learn more about extractables and leachables.

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Less Hamster Cell Growth, Less Product, Le$$ Profit

Biopharmaceuticals are drugs manufactured using cells, most commonly Chinese Hamster Ovary (CHO) cells, which are genetically engineered to produce a therapeutic protein. In recent years, biopharmaceutical manufacturers have moved from the use of stainless steel vessels (where the cells are grown), to single-use/disposable plastic systems. Single-use technology can theoretically be used throughout the various stages of bio-production, bringing with it the offer of reduced costs and simplified process set-up. Modern disposable plastic cell culture systems can now hold several thousand liters of cells and growth media. However, there are often concerns about what kind of compounds can leach from the single-use plastic bioprocess systems into the culture media. Chemical compounds added to plastics have been shown to leach into the cell culture liquid. Worryingly, some leachable compounds have been shown to strongly inhibit cell growth, even at exceptionally low PPM concentrations. Less cell growth, less product, less profit.

How do I Avoid Toxic Leachables?

There are thousands of polymers used in pharmaceutical packaging and production systems and countless unknown chemicals that may leach –says Andrew Feilden, industry expert, in a recent editorial.

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Risk assessments are conducted from material tested via forced extraction studies. All compounds must be confidently identified so that toxicologists can make an accurate risk assessment. Or, in the case of bio-production, studies of cell growth can be made in the presence of the leached compound. Final stability testing of the drug formulation and packaging is conducted to ensure high-risk compounds do not leach into the product in significant quantities.

Extractables and leachables testing demands technology that is capable of both unknown identification and quantification, at exceptionally low levels – in other words, technology capable of finding a needle amongst the haystack. Orbitrap-based High Resolution Accurate Mass (HRAM) mass spectrometry meets this challenge admirably, as demonstrated in these new application notes:

Learn about the latest Orbitrap technology used for extractables & leachables testing:

 

Learn about the development of extractables and leachables testing from Glaxo Smith Kline:

 

Visit our dedicated website to find out more about how new analytical technologies can be used to protect bioproduction yields and reduce patient exposure to leachable impurities.