Large-Scale Assessment of Extractables and Leachables in Single-Use Bags for Biomanufacturing

Author:

Dorival-García Noemí1,Carillo Sara1,Ta Christine1,Roberts Dominic2,Comstock Kate3,Lofthouse Simon4,Ciceri Elena5,D’Silva Kyle4,Kierans Gerald6,Kaisermayer Christian7,Lindeberg Anna7,Bones Jonathan18ORCID

Affiliation:

1. Characterization and Comparability Laboratory, NIBRT—The National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Blackrock, Co., Dublin, Ireland

2. Thermo Fisher Scientific, Manor Park, Tudor Rd, Cheshire, Runcorn WA7 1TA, United Kingdom

3. Thermo Fisher Scientific, 355 River Oaks Pkwy, San Jose, California 95134, United States

4. Thermo Fisher Scientific, Stafford House, Boundary Park, Hemel Hempstead HP2 7GE, United Kingdom

5. Thermo Fisher Scientific, Via Milano, 4, 20090 Rodano, MI, Italy

6. Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Nangor Road, Clondalkin, Dublin 22 D22 V8F8, Ireland

7. BioMarin International Limited, Shanbally, Ringaskiddy, Co. Cork P43 R298, Ireland

8. School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, Dublin 4, Ireland

Funder

Science Foundation Ireland

European Regional Development Fund

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

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