{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T06:07:30Z","timestamp":1779170850631,"version":"3.51.4"},"reference-count":38,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T00:00:00Z","timestamp":1739318400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T00:00:00Z","timestamp":1739318400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Appl Biosaf."],"published-print":{"date-parts":[[2025,9,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Serum and other blood-derived products are widely used in biomedical and biopharmaceutical processes, especially for the production of vaccines or cell therapeutic applications. To ensure quality and safety, each serum lot undergoes testing for sterility to minimize the risk of disease transmission. A currently performed standard procedure is gamma-irradiation of serum for effectively killing pathogens. However, gamma irradiation can only be performed in highly shielded, specialized facilities. Low-energy electron irradiation (LEEI) is an alternative, Good Manufacturing Practice (GMP) compatible method for sterilizing serum in a standard laboratory environment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>We directly compared the sensitivity of viruses belonging to the family of flaviviruses (Zika virus and bovine viral diarrhea virus) and parvoviruses (minute virus of mice) against LEEI in 90% serum or buffer. Although the reduction is more effective in buffer than in serum, the calculated decimal reduction dose values suggest that LEEI can efficiently sterilize serum by inactivating viruses, thereby increasing product safety and extending shelf life. Furthermore, LEEI-treated serum was tested as a supplement in cell culture and showed comparable performance to nonirradiated or gamma-irradiated serum when used for the cultivation of different cell lines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>LEEI is able to inactivate viral contaminants in serum and offers significant advantages over gamma irradiation, as no large amounts of radioactivity are generated, on-site irradiation is possible, and space requirements are reduced due to fewer protective measures. These advantages allow the technology to be used in a GMP-compliant irradiation process.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/apb.2024.0031","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T11:30:32Z","timestamp":1739359832000},"page":"264-271","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Low-Energy Electron Irradiation Inactivates Viruses in Serum and Maintains Growth-Promoting Properties in Cell Culture"],"prefix":"10.1177","volume":"30","author":[{"given":"Jasmin","family":"Fertey","sequence":"first","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustavo R.","family":"Makert","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philipp","family":"Becker","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Finkensieper","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Ulbert","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,2,12]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2006.07.003"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bsheal.2019.12.001"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41587-020-0507-2"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.4155\/pbp.14.62"},{"key":"e_1_3_5_6_2","unstructured":"U.S. Food and Drug Administration. Q5A(R2) Viral Safety. Evaluation of Biotechnology Products Derived from CellLines of Human or Animal Origin Guidance for Industry. 2024. Available from: https:\/\/www.fda.gov\/media\/163115\/download [Last accessed January30 2025]."},{"key":"e_1_3_5_7_2","unstructured":"European Medicines Agency. Guideline on Sterilisation of the Medicinal Product Active Substance Excipient and Primary Container. EMA\/CHMP\/CVMP\/QWP\/850374\/2015. 2019. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-sterilisation-medicinal-product-active-substance-excipient-and-primary-container_en.pdf [Last accessed January30 2025]."},{"key":"e_1_3_5_8_2","unstructured":"U.S. Food and Drug Administration. Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. 2010. Available from: https:\/\/www.fda.gov\/media\/78428\/download [Last accessed January30 2025]."},{"key":"e_1_3_5_9_2","unstructured":"U.S. Food and Drug Administration. Chemistry Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)\u2014Guidance for Industry. 2018. Available from: https:\/\/www.fda.gov\/media\/113760\/download [Last accessed January30 2025]."},{"key":"e_1_3_5_10_2","unstructured":"International Organisation for Standardization. ISO 11137-2:2013; Sterilization of health care products\u2014Radiation. Part 2: Establishing the sterilization dose. 2013. 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