sdfWhen you produce a biopharmaceutical you grow living cells that are engineered to express (produce) a therapeutic protein drug. These cells grow in BIG plastic bags. Very big. Sometimes several thousand liters in volume. This process takes days, even weeks, and can cost millions of dollars. Living cells must be cultured in carefully controlled conditions using specialist equipment to ensure high protein bioproduction yields. If cell health is compromised it can result in lower production yields, lost batches and lower profits.

One area of concern for bioproduction companies is ‘what’s in the bag?’ The plastic materials used by some ‘single-use’ plastic bioreactor manufacturers can contain a range of unknown monomers, antioxidants, plasticizers, slip agents, solvents etc.  – all compounds that could potentially leach from the polymer into the cell-culture media. In 2014, researchers at Amgen have shown that a popular antioxidant polymer additive Irgafos 168 degrades to a compound called bDtBPP during bag sterilization. bDtBPP was shown to have very harmful effects to a variety of cell lines at concentrations well below the parts-per-million (<PPM) range. An ultra-trace impurity that could potentially kill your production process is an alarming possibility. This issue represents a risk to the production of biopharmaceuticals and the industry has been trying to minimize that risk.

bDtBPP forms from irradiation of Irgafos 168

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Extractables and Leachables Research at NIBRT

The National Institute for Bioprocessing Research and Training (NIBRT) is a global leader in bioprocess and biopharmaceutical analysis. NIBRT is publishing new research from an industry collaboration investigating extractable & leachable impurities in the manufacturing of biopharmaceuticals.

The project is believed to be the largest public research project to date focused on migration of leachable impurities from bioprocess materials. To develop this report, NIBRT collaborated with Thermo Fisher Scientific, Allergan Pharmaceuticals Ireland, BioMarin International Ltd., Eli Lilly and Company, Genzyme Ireland Ltd, Janssen Biologics, MSD and Pfizer Ireland Pharmaceuticals. NIBRT used the latest chromatography, mass spectrometry and informatics solutions in this study, performing >1500 analyses. The technology included:

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The report is expected to be peer review published early in 2017. You can register to receive a copy of the NIBRT Bioprocess E&L report upon publication using this form.

Dr. Noemi Dorival Garcia (Researcher, NIBRT) will also be presenting this groundbreaking research at the Extractables & Leachables Europe 2016 conference, in Dublin on 10 November.

More on Extractables and Leachables

For more information on the technology used to perform identification and quantification of unknown leachable impurities please visit www.thermofisher.com/leachables.

 

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