Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Anthony S. Lubiniecki"'
Autor:
Anthony S. Lubiniecki
The debate over the potential risk of tumorigenicity attributable to the use of CCL substrates for biologicals production has continued for over 30 years and may continue for some time to come. Manufacturers and regulatory agencies are developing sci
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c89aa799e2a0b93423bc799ed6daad48
https://doi.org/10.1201/9780203749166-18
https://doi.org/10.1201/9780203749166-18
Autor:
Anthony S Lubiniecki
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 65:547-556
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Mic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b09479380b3211e6f7dff0ec5ca8adc5
https://doi.org/10.5731/pdajpst.2011.00818
https://doi.org/10.5731/pdajpst.2011.00818
Autor:
Anthony S. Lubiniecki
Publikováno v:
Cytotechnology. 28:139-145
Cell culture engineering has enabled the commercial marketing of about a dozen human therapeutic products derived from rDNA technology and numerous monoclonal antibody products as well. A variety of technologies have proven useful in bringing product
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6129a631430871aa359cd591fcb8efd5
https://doi.org/10.1023/a:1008094017583
https://doi.org/10.1023/a:1008094017583
Autor:
Anthony S. Lubiniecki
Publikováno v:
Current Opinion in Biotechnology. 8:350-356
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::db30310827e428654cf16e0a69184e8d
https://doi.org/10.1016/s0958-1669(97)80016-x
https://doi.org/10.1016/s0958-1669(97)80016-x
Autor:
Linda C, Hendricks, Jarrat, Jordan, Tong-Yuan, Yang, Paul, Driesprong, Gert Jan, Haan, Mareike, Viebahn, Thomas, Mikosch, Henri, Van Drunen, Anthony S, Lubiniecki
Publikováno v:
PDA journal of pharmaceutical science and technology. 64(5)
Out-of-specification (OOS) results were reported by a contract lab in the in vitro adventitious agent assay (AVA) for two products manufactured using mouse myeloma cells in perfusion bioreactors. Cytopathic effect observed for test article-inoculated
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::aa2ef9eb98bb2393eb0923a2289967ed
https://pubmed.ncbi.nlm.nih.gov/21502055
https://pubmed.ncbi.nlm.nih.gov/21502055
Publikováno v:
Current Opinion in Biotechnology. 12:317-319
Product development activity in the past five to ten years has reconstituted a version of an old debate on the safety assessment of biological products, namely whether the use of some types of continuous cell lines (CCLs) is appropriate in the prepar
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c1a4b961a7841091526f4e16b415447f
https://doi.org/10.1016/s0958-1669(00)00219-6
https://doi.org/10.1016/s0958-1669(00)00219-6
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 34(1)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::49ea1ef84888cdf8b72bffdcba6c1c78
https://pubmed.ncbi.nlm.nih.gov/16330221
https://pubmed.ncbi.nlm.nih.gov/16330221
Autor:
Anthony S. Lubiniecki
Publikováno v:
Current Applications of Cell Culture Engineering ISBN: 9789401060110
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a079b1e925b199a67ec46c91b9c44700
https://doi.org/10.1007/978-94-011-4786-6_15
https://doi.org/10.1007/978-94-011-4786-6_15
Autor:
Jan H. Lupker, Anthony S. Lubiniecki
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 22(2)
During the past 7 years, 14 versions of 7 rDNA proteins have been licensed which are derived from animal cell culture expression systems. These medically useful products have included hormones, coagulation factors, enzymes and a vaccine. Aspects of t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0e2bf0f06d7ca8e5c81ee742566e1f44
https://pubmed.ncbi.nlm.nih.gov/7522477
https://pubmed.ncbi.nlm.nih.gov/7522477