Zobrazeno 1 - 10
of 24
pro vyhledávání: '"Ashwinkumar A. Bhirde"'
Publikováno v:
Theranostics, Vol 1, Iss 1, Pp 310-321 (2011)
Recently portable Raman probes have emerged along with a variety of applications, including carbon nanotube (CNT) characterization. Aqueous dispersed CNTs have shown promise for biomedical applications such as drug/gene delivery vectors, photo-therma
Externí odkaz:
https://doaj.org/article/7a2fab1a214b430e9a476b15c2853c80
Autor:
Ramesh Venna, Bhaskara Vijaya Chikkaveeraiah, Cyrus Agarabi, Ashwinkumar A. Bhirde, Kurt Brorson, Rachel Carley
Publikováno v:
Journal of Pharmaceutical Sciences. 109:3330-3339
The presence of aggregates in monoclonal antibody (mAb) drug product (DP) formulations can present product quality challenges. Here we show that use of High Performance Size Exclusion Chromatography (HP-SEC), in conjunction with high-throughput dynam
Autor:
Kang Chen, Meiyu Shen, Cyrus Agarabi, Meng-Jung Chiang, Patrick Lynch, Weiming Ouyang, Faruk Sheikh, Sharadrao M. Patil, Ankit B. Shah, Raymond P. Donnelly, Kurt Brorson, Hui Fang, Sarah Rogstad, Phillip Angart, David M. Frucht, Sarah J. Schrieber, Ashwinkumar A. Bhirde, Tao Xie, Kristina E. Howard
Publikováno v:
Scientific Reports, Vol 10, Iss 1, Pp 1-12 (2020)
Scientific Reports
Scientific Reports
PEGylated recombinant human granulocyte colony stimulating factor (pegfilgrastim) is used clinically to accelerate immune reconstitution following chemotherapy and is being pursued for biosimilar development. One challenge to overcome in pegfilgrasti
Autor:
Franziska Schleinzer, Dennis T. Yang, Dean C. Ripple, Nazar Filonov, Pascal Chalus, Tapan K. Das, Kurt D. Benkstein, Ashwinkumar A. Bhirde, Stefan Romeijn, Fook Chiong Cheong, Sambit R. Kar, Laura A. Philips, Christine Probst, Adam D. Grabarek, Nicole S. Gill, Maciej Jarzebski, Yoen Joo Kim, David L. Duewer, Miguel Saggu, Andrew D. Hollingsworth, Gurusamy Balakrishnan, Judith Hadley, Vikram Kestens, Yannic Ramaye, Anja Matter, Wesley W. Howard, Theodore W. Randolph, Ngoc Do, Jan Kuba Tatarkiewicz, David G. Grier, Heather Anne Wright, Patrick Garidel, Atanas Koulov, Wim Jiskoot, Jared R. Snell, Harshit Khasa
Publikováno v:
J Pharm Sci
Journal of Pharmaceutical Sciences
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/
https://europepmc.org/articles/PMC9912188/
Publikováno v:
Nanoscale. 9:2291-2300
Colloidal nanoparticles have shown tremendous potential as cancer drug carriers and as phototherapeutics. However, the stability of nanoparticles under physiological and phototherapeutic conditions is a daunting issue, which needs to be addressed in
Publikováno v:
Journal of pharmaceutical sciences. 107(8)
Stability of therapeutic proteins (TPs) is a critical quality attribute that impacts both safety and efficacy of the drug. Size stability is routinely performed during and after biomanufacturing. Dynamic light scattering (DLS) is a commonly used tech
Publikováno v:
Physical Biology. 14:046001
Amyloid fibrils are highly structured protein aggregates associated with a wide range of diseases including Alzheimer's and Parkinson's. We report a structural investigation of an amyloid fibril model prepared from a commonly used plasma protein (bov
Publikováno v:
Physical Biology; Aug2017, Vol. 14 Issue 4, p1-1, 1p
Autor:
Kim M; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Ma Y; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Srinivasan C; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., O'Connor T; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Telikepalli SN; Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD, USA., Ripple DC; Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD, USA., Lute S; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Scott.Lute@fda.hhs.gov., Bhirde A; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Ashwinkumar.Bhirde@fda.hhs.gov.
Publikováno v:
Scientific reports [Sci Rep] 2023 Nov 22; Vol. 13 (1), pp. 20473. Date of Electronic Publication: 2023 Nov 22.
Autor:
Telikepalli SN; NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA. srivalli.telikepalli@nist.gov., Carrier MJ; NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA., Ripple DC; NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA., Barnett G; Currently at Lundbeck Seattle Biopharmaceuticals, Inc., Bothell, Washington, USA., Bhirde A; Food and Drug Administration, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA., Bolton D; Porton Biopharma Ltd., Salisbury, UK., Bou-Assaf GM; Biogen, Analytical Development, Cambridge, Massachusetts, USA., Ferrari E; Sanofi, BioAnalytics Germany, Characterization, Frankfurt Am Main, Germany., Leigh S; FibroGen, Inc., Analytical Development, San Francisco, California, USA., Levitskaya-Seaman S; MacroGenics, Inc., Analytical Sciences, BPD, Rockville, Maryland, USA., Menzen T; Coriolis Pharma Research Gmbh, Martinsried, Germany., Nikels F; Boehringer Ingelheim Pharma GmbH & Co., Innovation Unit, Biberach, KG, Germany., Riley A; Eli Lilly and Company, Global Quality Laboratories, Indianapolis, Indiana, USA., Saggu M; Genentech, Inc., Pharmaceutical Development, San Francisco, California, USA., Sahni N; Currently at MacroGenics, Drug Product Sciences, Drug Product Development, Rockville, Maryland, USA., Vernooij E; AstraZeneca, Global Operations Biologics, Nijmegen Manufacturing Facility, Nijmegen, Netherlands., Wuchner K; Janssen R&D, DPDS BTDS Analytical Development, Schaffhausen, Switzerland.
Publikováno v:
AAPS PharmSciTech [AAPS PharmSciTech] 2022 Dec 16; Vol. 24 (1), pp. 18. Date of Electronic Publication: 2022 Dec 16.