{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T03:48:26Z","timestamp":1778644106189,"version":"3.51.4"},"reference-count":31,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,2,13]],"date-time":"2020-02-13T00:00:00Z","timestamp":1581552000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["aiche.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biotechnology Progress"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The contamination of oral rotavirus vaccines by porcine circovirus (PCV) raised questions about potential PCV contamination of other biological products when porcine trypsin or pepsin is used in production process. Several methods can be potentially implemented as a safety barrier when animal derived trypsin or pepsin is used. Removal of PCV is difficult by the commonly used viral filters with the pore size cutoff of approximately 20\u2009nm because of the smaller size of PCV particles that are around 17\u2009nm. It was speculated that operating the chromatography step at a pH higher than pepsin's low pI, but lower than pIs, of most viruses would allow the pepsin to flow through the resin and be recovered from the flow through pool whilst the viruses would be retained on the resin. In this study, we investigated low pH inactivation of viruses including PCV Type 1 (PCV1) and PCV1 removal by cation exchange chromatography (CEX) in the presence of pepsin. Both parvovirus and PCV1 could be effectively inactivated by low pH and PCV1 could be removed by POROS 50HS CEX. The POROS 50HS method presented in this article is helpful for designing other CEX methods for the same purpose and not much difference would be expected for similar product intermediates and same process parameters. While the effectiveness needs to be confirmed for specific applications, the results demonstrate that both low pH (pH\u20091.7) and CEX methods were successful in eliminating PCV1 and thus either can be considered as an effective virus barrier.<\/jats:p>","DOI":"10.1002\/btpr.2968","type":"journal-article","created":{"date-parts":[[2020,1,28]],"date-time":"2020-01-28T03:12:52Z","timestamp":1580181172000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Clearance of porcine circovirus and porcine parvovirus from porcine\u2010derived pepsin by low pH inactivation and cation exchange chromatography"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4897-0693","authenticated-orcid":false,"given":"Bin","family":"Yang","sequence":"first","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hua","family":"Wang","sequence":"additional","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"Kaleas","sequence":"additional","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle","family":"Butler","sequence":"additional","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jayme","family":"Franklin","sequence":"additional","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amber","family":"Bill","sequence":"additional","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sally A.","family":"Baylis","sequence":"additional","affiliation":[{"name":"Virus Safety Section Paul\u2010Ehrlich\u2010Institut, Federal Institute for Vaccines and Biomedicines  Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qi","family":"Chen","sequence":"additional","affiliation":[{"name":"Purification Development Genentech, Inc., One DNA Way  South San Francisco California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes","family":"Bl\u00fcmel","sequence":"additional","affiliation":[{"name":"Virus Safety Section Paul\u2010Ehrlich\u2010Institut, Federal Institute for Vaccines and Biomedicines  Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,2,13]]},"reference":[{"key":"e_1_2_6_2_1","volume-title":"Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, Q5A","author":"ICH","year":"1998"},{"key":"e_1_2_6_3_1","unstructured":"EMA.2010a. European Medicines Agency sees no safety concerns with the Rotarix oral vaccine. London UK: European Medicines Agency. Doc. Ref. EMA\/CHMP\/201923\/2010."},{"key":"e_1_2_6_4_1","unstructured":"EMA2010b. European Medicines Agency confirms positive benefit\u2010risk balance of Rotarix. London UK: European Medicines Agency. Doc. Ref. 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