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Page 1
Validation of fermentation processes.
Lubiniecki AS, Gardner AR, Smith TM, Wang WK, McAllister PR, Federici MM. Lubiniecki AS, et al. Dev Biol (Basel). 2003;113:37-44; discussion 111-2. Dev Biol (Basel). 2003. PMID: 14620850
Comparability is not just analytical equivalence.
Lubiniecki AS, Marcia Federici M. Lubiniecki AS, et al. Biologicals. 2006 Mar;34(1):45-7. doi: 10.1016/j.biologicals.2005.08.016. Epub 2005 Dec 2. Biologicals. 2006. PMID: 16330221 No abstract available.
Taking immunogenicity assessment of therapeutic proteins to the next level.
Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, Subramanyam M, Thorpe R, Trouvin JH, Weise M, Windisch J, Schneider CK. Büttel IC, et al. Among authors: lubiniecki a. Biologicals. 2011 Mar;39(2):100-9. doi: 10.1016/j.biologicals.2011.01.006. Epub 2011 Feb 24. Biologicals. 2011. PMID: 21353596
Genetic stability and recombinant product consistency.
Burstyn D, Copmann T, Dinowitz M, Garnick R, Losikoff A, Lubiniecki A, Wiebe M. Burstyn D, et al. Among authors: lubiniecki a. Biologicals. 1993 Jun;21(2):147-9. doi: 10.1006/biol.1993.1064. Biologicals. 1993. PMID: 8297595 Review.
Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.
Kay J, Feagan BG, Guirguis MS, Keystone EC, Klein AV, Lubiniecki AS, Mould DR, Nyarko KA, Ridgway AA, Trudeau ME, Wang J. Kay J, et al. Among authors: lubiniecki as. Biologicals. 2012 Nov;40(6):517-27. doi: 10.1016/j.biologicals.2012.09.010. Epub 2012 Oct 17. Biologicals. 2012. PMID: 23084808 Free article.
79 results