Výsledky vyhledávání - "Adam D. Grabarek"

Immunological Evaluation In Vitro of Nanoparticulate Impurities Isolated From Pharmaceutical-Grade Sucrose

Autor: Wim Jiskoot, Andrea Hawe, Adam D. Grabarek, Isabelle Turbica, Myriam Nabhan, Marc Pallardy

Publikováno v: Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences, 110(2), 952-958

Sucrose is a commonly used stabilizing excipient in protein formulations. However, recent studies have indicated the presence of nanoparticulate impurities (NPIs) in the size range of 100-200 nm in pharmaceutical-grade sucrose. Furthermore, isolated

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::62f2aec65e2a09541dbf19fe0a6214a2
https://doi.org/10.1016/j.xphs.2020.11.011

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What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress

Autor: Tim Menzen, Wim Jiskoot, Wendelin Kranz, Adam D. Grabarek, Jannik Rousel, Klaus Wuchner, Andrea Hawe, Ula Bozic

Publikováno v: Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences, 109(1), 871-880

Polysorbate 80 (PS80) is a commonly used surfactant in therapeutic protein formulations to mitigate adsorption and interface-induced protein aggregation. Several PS80 grades and qualities are available on the market for parenteral application. The ro

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4b00ef3a8b6d458bbf05dd2a7c022bd9
https://doi.org/10.1016/j.xphs.2019.10.015

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An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion

Publikováno v: J Pharm Sci
Journal of Pharmaceutical Sciences

The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ebec099deb60130fdbf19d1d6774ab17
https://europepmc.org/articles/PMC9912188/

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Forced degradation of cell-based medicinal products guided by flow imaging microscopy

Autor: Adam D. Grabarek, Wim Jiskoot, T. Menzen, Andrea Hawe, K. Pike-Overzet

Publikováno v: European Journal of Pharmaceutics and Biopharmaceutics, 167, 38-47
European Journal of Pharmaceutics and Biopharmaceutics

Cell-based medicinal products (CBMPs) offer ground-breaking opportunities to treat diseases with limited or no therapeutic options. However, the intrinsic complexity of CBMPs results in great challenges with respect to analytical characterization and

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ffe3d23a15ca2afe4939836f73a9cfc
https://doi.org/10.1016/j.ejpb.2021.07.004

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Particulate impurities in cell-based medicinal products traced by flow imaging microscopy combined with deep learning for image analysis

Autor: E. Senel, Wim Jiskoot, Adam D. Grabarek, Tim Menzen, Karin H. Hoogendoorn, K. Pike-Overzet, Andrea Hawe

Publikováno v: Cytotherapy, 23(4), 339-347
Cytotherapy, 23(4), 339-347. ELSEVIER SCI LTD

Cell-based medicinal products (CBMPs) are rapidly gaining importance in the treatment of life-threatening diseases. However, the analytical toolbox for characterization of CBMPs is limited. The aim of our study was to develop a method based on flow i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::66f6af1f29a1c72fdae49bc28c4bf1ff
https://pubmed.ncbi.nlm.nih.gov/32507606

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Simultaneous automated image analysis and Raman spectroscopy of powders at an individual particle level

Autor: Andrea Sekulovic, Wim Jiskoot, Jukka Rantanen, Adam D. Grabarek, Thomas Rades, R. Verrijk, Andrea Hawe

Publikováno v: Journal of Pharmaceutical and Biomedical Analysis
Journal of Pharmaceutical and Biomedical Analysis, 193, 113744

Solid form diversity of raw materials can be critical for the performance of the final drug product. In this study, Raman spectroscopy, image analysis and combined Raman and image analysis were utilized to characterize the solid form composition of a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d18c19314dc5abf79a80c019b2aa7e35
https://doi.org/10.1016/j.jpba.2020.113744

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Critical Evaluation of Microfluidic Resistive Pulse Sensing for Quantification and Sizing of Nanometer- and Micrometer-Sized Particles in Biopharmaceutical Products

Autor: Wim Jiskoot, Adam D. Grabarek, Daniel Weinbuch, Andrea Hawe

Publikováno v: Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences, 108(1), 563-573

The objective was to evaluate performance, strengths, and limitations of the microfluidic resistive pulse sensing (MRPS) technique for the characterization of particles in the size range from about 50 to 2000 nm. MRPS, resonant mass measurement (RMM)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ec3bd8690c98e61409dd27642758637f
https://pubmed.ncbi.nlm.nih.gov/30176253

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