Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
G Shankar, V Devanarayan, L Amaravadi… - … of pharmaceutical and …, 2008 - Elsevier
Most biological drug products elicit some level of anti-drug antibody (ADA) response. This
antibody response can, in some cases, lead to potentially serious side effects and/or loss of …
antibody response can, in some cases, lead to potentially serious side effects and/or loss of …
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
E Koren, HW Smith, E Shores, G Shankar… - Journal of …, 2008 - Elsevier
The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major
importance for their successful development and licensure. Antibodies elicited by these …
importance for their successful development and licensure. Antibodies elicited by these …
[HTML][HTML] Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics
MK Joubert, M Deshpande, J Yang, H Reynolds… - PloS one, 2016 - journals.plos.org
An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool
for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral …
for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral …
Reprint: Six-month continuous intraputamenal infusion toxicity study of recombinant methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF) in …
DN Hovland Jr, RB Boyd, MT Butt… - Toxicologic …, 2007 - journals.sagepub.com
Recombinant human glial cell line-derived neurotrophic factor (r-metHuGDNF) is a potent
neuronal growth and survival factor that has been considered for clinical use in the treatment …
neuronal growth and survival factor that has been considered for clinical use in the treatment …
Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact
SM Tatarewicz, DT Mytych, MS Manning, SJ Swanson… - Bioanalysis, 2014 - Future Science
All therapeutic proteins have the potential to induce anti-drug antibodies (ADA). Clinically
relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity …
relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity …
A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab
P Kaur, V Chow, N Zhang, M Moxness… - Annals of the …, 2017 - ard.bmj.com
Objective To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501
relative to adalimumab reference product from the USA and European Union (EU) and …
relative to adalimumab reference product from the USA and European Union (EU) and …
Terminal and new bridging coordination of methylguanidine, arginine, and canavanine to platinum (II). The first crystallographic study of bonding between a transition …
EMA Ratilla, BK Scott, MS Moxness… - Inorganic …, 1990 - ACS Publications
The compound [Pt (trpy) Cl] Cl reacts with the guanidine-containing compounds
methylguanidine, arginine, and canavanine to form the yellow monometallic complexes [Pt …
methylguanidine, arginine, and canavanine to form the yellow monometallic complexes [Pt …
Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies
M Moxness, S Tatarewicz, D Weeraratne… - Clinical …, 2005 - academic.oup.com
Kidney disease affects more than 20 million individuals in the United States alone. Although
the causes of kidney failure are diverse, the glomerular filtration barrier is often the target of …
the causes of kidney failure are diverse, the glomerular filtration barrier is often the target of …
Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe
BB Yang, PK Morrow, X Wu, M Moxness… - Cancer Chemotherapy …, 2015 - Springer
Purpose For patients with clinically significant risk of febrile neutropenia, pegfilgrastim
administration should occur the day after myelosuppressive chemotherapy; however, a …
administration should occur the day after myelosuppressive chemotherapy; however, a …
Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics
S Tatarewicz, JM Miller, SJ Swanson… - Journal of immunological …, 2010 - Elsevier
Rheumatoid factors (RFs) are endogenous human antibodies that bind to human gamma
globulins. RFs demonstrate preferential binding to aggregated gamma globulins and are …
globulins. RFs demonstrate preferential binding to aggregated gamma globulins and are …