Groundbreaking research in single-use bioprocess extractables and leachables
Download NIBRT E&L Study report published in journal of Analytical Chemistry for free
The National Institute for Bioprocessing Research and Training ( 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.
More about the research:
- 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
- Pfizer Ireland Pharmaceuticals
- The project investigated bioprocess films from 5 vendors of single-use bioprocess bags.
- 4 extractable solvent model systems were used, plus a simulated leachable study using cell culture media.
- >1500 sample analyses performed using headspace GC-MS, GC-MS/MS, LC-MS/MS and ICP-MS.
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