全部文献期刊学位论文会议报纸专利标准年鉴图书|学者科研项目
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作者:Valerie Quarmby , Hanns-Christian Mahler ...
来源:[J].The AAPS Journal(IF 4.386), 2017, Vol.19 (6), pp.1656-1668Springer
摘要:Therapeutic breakthroughs in a number of retinal degenerative diseases have come about through the development of biotherapeutics administered directly into the eye. As a consequence of their use, we have gained more insight into the immune privileged status of the eye and the va...
作者:... Amy Rosenberg , Susan Kirshner , Valerie Quarmby
来源:[J].The AAPS Journal(IF 4.386), 2014, Vol.16 (3), pp.499-503Springer
摘要:Abstract(#br)A “Late Breaking” session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration’s (FDA) 2013 draft guidance on Immunogenicity Assessment for The...
作者:Valerie Quarmby , Tilman Schlothauer ...
来源:[J].Biologicals(IF 1.616), 2016, Vol.44 (5), pp.291-305Elsevier
摘要:Abstract(#br)Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The prin...
作者:... Jihong Yang , Valerie Quarmby , An Song
来源:[J].Journal of Immunological Methods(IF 2.225), 2014, Vol.407, pp.63-75Elsevier
摘要:Abstract(#br)Antibody-dependent cell-mediated cytotoxicity (ADCC) is an important mechanism of action implicated in the clinical efficacy of several therapeutic antibodies. In vitro ADCC assays employing effector cells capable of inducing lysis of target cells bound by antibodies...
作者:... Kevin Lin , Valerie Quarmby , Jihong Yang
来源:[J].mAbs(IF 5.275), 2017, Vol.9 (2), pp.319-332Taylor & Francis
摘要:ABSTRACT(#br)Binding interactions with the neonatal Fc receptor (FcRn) are one determinant of pharmacokinetic properties of recombinant human monoclonal antibody (rhumAb) therapeutics, and a conserved binding motif in the crystallizable fragment (Fc) region of IgG molecules inter...
作者:Krista M. McCutcheon , Valerie Quarmby , An Song
来源:[J].Journal of Immunological Methods(IF 2.225), 2010, Vol.358 (1), pp.35-45Elsevier
摘要:Abstract(#br)We developed a neutralizing antibody assay (NAb assay), based upon the complement-dependent cytotoxicity (CDC) activity of a monoclonal human IgG 1 therapeutic (IgT), to characterize anti-therapeutic antibodies (ATA) in autoimmune patient serum. Neutralizing ant...
作者:... Jeriza Rusit , Rebecca Elliott , Valerie Quarmby
来源:[J].Journal of Pharmaceutical and Biomedical Analysis(IF 2.947), 2010, Vol.52 (5), pp.680-686Elsevier
摘要:Abstract(#br)A solution-phase electrochemiluminescence assay (ECLA) was developed to quantify ranibizumab in serum from patients treated with this biotherapeutic for neovascular age-related macular degeneration. Ranibizumab, a recombinant humanized Fab (“fragment, antigen bi...
作者:... Jenny Jiang , Valerie Quarmby , An Song
来源:[J].Journal of Immunological Methods(IF 2.225), 2010, Vol.362 (1-2), pp.101-111Elsevier
摘要:Abstract(#br)Electrochemiluminescence (ECL) assays have been widely used for the detection of anti-therapeutic antibodies (ATAs) against biotherapeutics. With the discontinuation of BioVeris ® (BV) ECL platform, an alternative technology was needed to replace BV assays to en...
作者:Valerie Quarmby , Herman Chu ...
来源:[J].Journal of Controlled Release(IF 7.633), 1997, Vol.49 (2), pp.193-205Elsevier
摘要:Abstract(#br)The treatment of growth hormone deficiency requires the daily administration of recombinant human growth hormone (rhGH). Long lasting formulations of rhGH have the potential to increase patient compliance, improve quality of life, and increase the efficacy of rh...
作者:... James Ernst , Gregory Bennett , Valerie Quarmby
来源:[J].Journal of Immunological Methods(IF 2.225), 2008, Vol.335 (1), pp.8-20Elsevier
摘要:Abstract(#br)Preclinical pharmacokinetic (PK) assays are important to help evaluate the safety and efficacy of a potential biotherapeutic before clinical studies. The assay typically requires a biotherapeutic-specific reagent to minimize matrix effects especially when the host sp...

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