These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
166 related articles for article (PubMed ID: 31063635)
1. Effect of protein cryoconcentration and processing conditions on kinetics of dimer formation for a monoclonal antibody: A case study on bioprocessing. Mehta SB; Subramanian S; D'Mello R; Brisbane C; Roy S Biotechnol Prog; 2019 Jul; 35(4):e2836. PubMed ID: 31063635 [TBL] [Abstract][Full Text] [Related]
2. Protein and solute distribution in drug substance containers during frozen storage and post-thawing: a tool to understand and define freezing-thawing parameters in biotechnology process development. Kolhe P; Badkar A Biotechnol Prog; 2011; 27(2):494-504. PubMed ID: 21302371 [TBL] [Abstract][Full Text] [Related]
3. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress. Gikanga B; Eisner DR; Ovadia R; Day ES; Stauch OB; Maa YF PDA J Pharm Sci Technol; 2017; 71(3):172-188. PubMed ID: 27789805 [TBL] [Abstract][Full Text] [Related]
4. Cryoconcentration and 3D Temperature Profiles During Freezing of mAb Solutions in Large-Scale PET Bottles and a Novel Scale-Down Device. Bluemel O; Buecheler JW; Rodrigues MA; Geraldes V; Hoelzl G; Bechtold-Peters K; Friess W Pharm Res; 2020 Aug; 37(9):179. PubMed ID: 32864719 [TBL] [Abstract][Full Text] [Related]
5. Characterization of mAb dimers reveals predominant dimer forms common in therapeutic mAbs. Plath F; Ringler P; Graff-Meyer A; Stahlberg H; Lauer ME; Rufer AC; Graewert MA; Svergun D; Gellermann G; Finkler C; Stracke JO; Koulov A; Schnaible V MAbs; 2016 Jul; 8(5):928-40. PubMed ID: 27031922 [TBL] [Abstract][Full Text] [Related]
6. The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - part 2: Aggregate formation and oxidation. Bluemel O; Buecheler JW; Hauptmann A; Hoelzl G; Bechtold-Peters K; Friess W Int J Pharm X; 2022 Dec; 4():100109. PubMed ID: 35024604 [TBL] [Abstract][Full Text] [Related]
7. Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study. Eisner DR; Hui A; Eppler K; Tegoulia V; Maa YF PDA J Pharm Sci Technol; 2019; 73(3):285-291. PubMed ID: 30651338 [TBL] [Abstract][Full Text] [Related]
8. Impact of freeze-thaw processes on monoclonal antibody platform process development. Weber D; Sittig C; Hubbuch J Biotechnol Bioeng; 2021 Oct; 118(10):3914-3925. PubMed ID: 34170514 [TBL] [Abstract][Full Text] [Related]
9. Kinetics and thermodynamics of dimer formation and dissociation for a recombinant humanized monoclonal antibody to vascular endothelial growth factor. Moore JM; Patapoff TW; Cromwell ME Biochemistry; 1999 Oct; 38(42):13960-7. PubMed ID: 10529242 [TBL] [Abstract][Full Text] [Related]
10. Kinetic Modeling of Methionine Oxidation in Monoclonal Antibodies from Hydrogen Peroxide Spiking Studies. Hui A; Lam XM; Kuehl C; Grauschopf U; Wang YJ PDA J Pharm Sci Technol; 2015; 69(4):511-25. PubMed ID: 26242787 [TBL] [Abstract][Full Text] [Related]
11. Stress Temperature Studies in Small Scale Hastelloy® Drug Substance Containers Lead to Increased Extent of and Increased Variability in Antibody-Drug Conjugate and Monoclonal Antibody Aggregation: Evidence for Novel Oxidation-Induced Crosslinking in Monoclonal Antibodies. Klair N; Kim MT; Lee A; Xiao NJ; Patel AR J Pharm Sci; 2021 Apr; 110(4):1615-1624. PubMed ID: 33035540 [TBL] [Abstract][Full Text] [Related]
12. Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations. Gikanga B; Hui A; Maa YF PDA J Pharm Sci Technol; 2018; 72(2):117-133. PubMed ID: 29030532 [TBL] [Abstract][Full Text] [Related]
13. Analytical characterization of coformulated antibodies as combination therapy. Kim J; Kim YJ; Cao M; De Mel N; Albarghouthi M; Miller K; Bee JS; Wang J; Wang X MAbs; 2020; 12(1):1738691. PubMed ID: 32138591 [TBL] [Abstract][Full Text] [Related]
14. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying-the Road to Manufacturing Scale. Gikanga B; Turok R; Hui A; Bowen M; Stauch OB; Maa YF PDA J Pharm Sci Technol; 2015; 69(1):59-73. PubMed ID: 25691715 [TBL] [Abstract][Full Text] [Related]
15. Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long-Term Stability of Monoclonal Antibodies. Luis LM; Hu Y; Zamiri C; Sreedhara A PDA J Pharm Sci Technol; 2018; 72(4):393-403. PubMed ID: 29853610 [TBL] [Abstract][Full Text] [Related]
16. First-order nucleation and subsequent growth promote liquid-liquid phase separation of a model IgG1 mAb. Tian Z; Xu L; Zhang N; Qian F Int J Pharm; 2020 Oct; 588():119681. PubMed ID: 32721563 [TBL] [Abstract][Full Text] [Related]
17. The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - Part 1: Higher molecular weight species and subvisible particle formation. Bluemel O; Anuschek M; Buecheler JW; Hoelzl G; Bechtold-Peters K; Friess W Int J Pharm X; 2022 Dec; 4():100108. PubMed ID: 35024603 [TBL] [Abstract][Full Text] [Related]
18. Challenges and solutions to manufacturing of low viscosity, ultra-high concentration IgG1 drug products: From late downstream process to final fill finish processing. Deokar VD; Sharma A; Subrahmanyam VM PDA J Pharm Sci Technol; 2024 Jun; ():. PubMed ID: 38942482 [TBL] [Abstract][Full Text] [Related]
19. Impact of freezing on pH of buffered solutions and consequences for monoclonal antibody aggregation. Kolhe P; Amend E; Singh SK Biotechnol Prog; 2010; 26(3):727-33. PubMed ID: 20039442 [TBL] [Abstract][Full Text] [Related]
20. Optimization of Methodologies to Study Freeze/Thaw Processes in Drug Substance Bottles. Peláez SS; Mahler HC; Huwyler J; Allmendinger A Methods Protoc; 2024 Sep; 7(5):. PubMed ID: 39311369 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]