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1 . Academic Journal
Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future
저자
by
Wuchner, Klaus
;
Yi, Linda
;
Chery, Cyrille
;
Nikels, Felix
;
Junge, Friederike
, et al.
소스
In
Journal of Pharmaceutical Sciences
November 2022 111(11):2955-2967
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7 . Academic Journal
Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates
저자
by
Wuchner, Klaus
;
Yi, Linda
;
Chery, Cyrille
;
Nikels, Felix
;
Junge, Friederike
, et al.
소스
In
Journal of Pharmaceutical Sciences
May 2022 111(5):1280-1291
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Web of Science
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7 . Academic Journal
Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product
저자
by
Seo, Neungseon
;
Huang, Zhe
;
Kuhns, Scott
;
Sweet, Heather
;
Cao, Shawn
, et al.
소스
In
Biologicals
November 2020 68:79-91
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7 . Academic Journal
Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts
저자
by
Cua, Michelle
;
Martin, Daniel
;
Meza, Patricia
;
Torraca, Gianni
;
Pearson, Thomas
, et al.
소스
In
Journal of Pharmaceutical Sciences
November 2020 109(11):3292-3299
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7 . Academic Journal
Characterization of Subvisible Particles in Biotherapeutic Prefilled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock
저자
by
Jiao, Nancy
;
Barnett, Gregory V.
;
Christian, Twinkle R.
;
Narhi, Linda O.
;
Joh, Nathan H.
, et al.
소스
In
Journal of Pharmaceutical Sciences
January 2020 109(1):640-645
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7 . Academic Journal
A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products
저자
by
Hubert, Mario
;
Yang, Dennis T.
;
Kwok, Stanley C.
;
Rios, Anacelia
;
Das, Tapan K.
, et al.
소스
In
Journal of Pharmaceutical Sciences
January 2020 109(1):830-844
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7 . Academic Journal
Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems
저자
by
Joh, Nathan H.
;
Thomas, Lisa
;
Christian, Twinkle R.
;
Verlinsky, Alla
;
Jiao, Nancy
, et al.
소스
In
Journal of Pharmaceutical Sciences
January 2020 109(1):845-853
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7 . Academic Journal
Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products.
저자
by
Saggu, Miguel
;
Bou-Assaf, George M.
;
Bucher, Reinhard
;
Budyak, Ivan L.
;
Buecheler, Jakob
, et al.
소스
Journal of Pharmaceutical Sciences
. May2024, Vol. 113 Issue 5, p1401-1414. 14p.
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7 . Academic Journal
Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product.
저자
by
Cantin, Greg
;
Liu, Qian
;
Shah, Bhavana
;
Kuhns, Scott
;
Wikström, Mats
, et al.
소스
Drugs in R&D
. Dec2023, Vol. 23 Issue 4, p421-438. 18p.
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7 . Academic Journal
Characterizing Reversible Protein Association at Moderately High Concentration Via Composition-Gradient Static Light Scattering
저자
by
Some, Daniel
;
Pollastrini, Joseph
;
Cao, Shawn
.
소스
In
Journal of Pharmaceutical Sciences
August 2016 105(8):2310-2318
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