Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Benson Gikanga"'
Autor:
Yuh-Fun Maa, Benson Gikanga
Publikováno v:
Journal of Pharmaceutical Sciences. 109:2363-2374
Mixing is an important unit operation in monoclonal antibody manufacturing. The goal is to achieve homogeneity without compromising product quality. Mixing-induced protein degradation and protein subvisible particle (SvP) formation, which impacts pro
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2dacf08365076e04afafd7bbdad9f014
https://doi.org/10.1016/j.xphs.2020.03.024
https://doi.org/10.1016/j.xphs.2020.03.024
Publikováno v:
Int J Pharm
This study explored the feasibility of electrostatic spray drying for producing a monoclonal antibody (mAb) powder formulation at lower drying temperatures than conventional spray drying and its effect on protein stability. A mAb formulation was drie
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9eae1ff79a9af49d5881c83601a19ddd
https://europepmc.org/articles/PMC8462225/
https://europepmc.org/articles/PMC8462225/
Autor:
Oliver B. Stauch, Robert Ovadia, Eric S. Day, Benson Gikanga, Yuh-Fun Maa, Devon Roshan Eisner
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 71:172-188
Subvisible particle formation in monoclonal antibody drug product resulting from mixing and filling operations represents a significant processing risk that can lead to filter fouling and thereby lead to process delays or failures. Several previous s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ea33a4879dc64336c82c93afe0ddc24
https://doi.org/10.5731/pdajpst.2016.006726
https://doi.org/10.5731/pdajpst.2016.006726
Publikováno v:
Bioconjugate Chemistry. 27:1040-1049
Antibody-drug conjugates (ADCs) require thorough characterization and understanding of product quality attributes. The framework of many ADCs comprises one molecule of antibody that is usually conjugated with multiple drug molecules at various locati
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::97ed454630abad9c8c22ea231859a300
https://doi.org/10.1021/acs.bioconjchem.6b00055
https://doi.org/10.1021/acs.bioconjchem.6b00055
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 69:284-296
Using bottom-mounted mixers, particularly those that are magnetically driven, is becoming increasingly common during the mixing process in pharmaceutical and biotechnology manufacturing because of their associated low risk of contamination, ease of u
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c64d3dd241fdfbeb58c00476f0ecf40a
https://doi.org/10.5731/pdajpst.2015.01031
https://doi.org/10.5731/pdajpst.2015.01031
Publikováno v:
PDA journal of pharmaceutical science and technology. 72(2)
Processing equipment involving grinding of two solid surfaces has been demonstrated to induce subvisible particle (SvP) formation in monoclonal antibody (mAb) drug product manufacturing processes. This study elucidated potential stress types associat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c0a28d3c9d26281c7399602105733e0
https://pubmed.ncbi.nlm.nih.gov/29030532
https://pubmed.ncbi.nlm.nih.gov/29030532
Autor:
Sarah A. Torhan, Benson Gikanga, Edwin Chan, Oliver B. Stauch, Wendy Shieu, Yuh-Fun Maa, Aaron Hubbard
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 68:153-163
Syringe filling, especially the filling of high-concentration/viscosity monoclonal antibody formulations, is a complex process that has not been widely published in literature. This study sought to increase the body of knowledge for syringe filling b
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::aeb39f3a7c5262bb882f192f15423e2d
https://doi.org/10.5731/pdajpst.2014.00973
https://doi.org/10.5731/pdajpst.2014.00973
Publikováno v:
PDA journal of pharmaceutical science and technology. 69(1)
Spray-dried monoclonal antibody (mAb) powders may offer applications more versatile than the freeze-dried cake, including preparing high-concentration formulations for subcutaneous administration. Published studies on this topic, however, are general
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f4447f8c49b3fd73cdd0b68ac7411211
https://pubmed.ncbi.nlm.nih.gov/25691715
https://pubmed.ncbi.nlm.nih.gov/25691715
Autor:
Jennifer Zhang, Hung-Wei Chih, Nia S. Beckley, Vikas K. Sharma, Benson Gikanga, Y. John Wang, Li Yi
Publikováno v:
Journal of pharmaceutical sciences. 102(3)
Isomerization of aspartyl (Asp or D) residues is a critical degradation route to consider for stable monoclonal antibody formulations. Among the known hotspot sequences, the DD motif is relatively understudied. To gain mechanistic insights, we used m
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ab131e3c51c2de918d4aa88b2bde0682
https://pubmed.ncbi.nlm.nih.gov/23280575
https://pubmed.ncbi.nlm.nih.gov/23280575
Publikováno v:
Journal of pharmaceutical sciences. 100(7)
Unexpected release of free drug was observed during the stability testing of an antibody–drug conjugate (ADC). The ADC was designed to use lysine–succinimidyl ester chemistry to conjugate small molecule cytotoxic drugs to the antibody. To elucida
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c19d20f948f75ddc39f42ff337a782a6
https://pubmed.ncbi.nlm.nih.gov/21294129
https://pubmed.ncbi.nlm.nih.gov/21294129