Forced degradation studies of biopharmaceuticals: Selection of stress conditions

E Tamizi, A Jouyban - European Journal of Pharmaceutics and …, 2016 - Elsevier
Stability studies under stress conditions or forced degradation studies play an important role
in different phases of development and production of biopharmaceuticals and biological …

Accelerated formulation development of monoclonal antibodies (mAbs) and mAb-based modalities: review of methods and tools

VI Razinkov, MJ Treuheit… - Journal of biomolecular …, 2015 - journals.sagepub.com
More therapeutic monoclonal antibodies and antibody-based modalities are in development
today than ever before, and a faster and more accurate drug discovery process will ensure …

Artificial nacre-like papers based on noncovalent functionalized boron nitride nanosheets with excellent mechanical and thermally conductive properties

X Zeng, L Ye, S Yu, H Li, R Sun, J Xu, CP Wong - Nanoscale, 2015 - pubs.rsc.org
Inspired by the nano/microscale hierarchical structure and the precise inorganic/organic
interface of natural nacre, we fabricated artificial nacre-like papers based on noncovalent …

Structural characterization of IgG1 mAb aggregates and particles generated under various stress conditions

SN Telikepalli, OS Kumru, C Kalonia… - Journal of …, 2014 - Elsevier
IgG1 mAb solutions were prepared with and without sodium chloride and subjected to
different environmental stresses. Formation of aggregates and particles of varying size was …

Evaluating the role of the air-solution interface on the mechanism of subvisible particle formation caused by mechanical agitation for an IgG1 mAb

S Ghazvini, C Kalonia, DB Volkin, P Dhar - Journal of pharmaceutical …, 2016 - Elsevier
Mechanical agitation of monoclonal antibody (mAb) solutions often leads to protein particle
formation. In this study, various formulations of an immunoglobulin G (IgG) 1 mAb were …

Leaf photosynthesis and senescence in heated and droughted field-grown soybean with contrasting seed protein concentration

VV Ergo, RE Veas, CRC Vega, R Lascano… - Plant Physiology and …, 2021 - Elsevier
Soybean plants under heat and drought generate a multiplicity of responses in
photosynthesis and senescence, impairing growth, yield, and seed quality. The goal of this …

Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis

V Corvari, LO Narhi, TM Spitznagel, N Afonina, S Cao… - Biologicals, 2015 - Elsevier
Measurement and characterization of subvisible particles (including proteinaceous and non-
proteinaceous particulate matter) is an important aspect of the pharmaceutical development …

Effects of protein conformation, apparent solubility, and protein–protein interactions on the rates and mechanisms of aggregation for an IgG1Monoclonal antibody

C Kalonia, V Toprani, R Toth, N Wahome… - The Journal of …, 2016 - ACS Publications
Non-native protein aggregation is a key degradation pathway of immunoglobulins. In this
work, the aggregation kinetics of an immunoglobulin gamma-1 monoclonal antibody (IgG1 …

A new method for nondestructive quality evaluation of the resistance spot welding based on the radar chart method and the decision tree classifier

H Zhang, Y Hou, J Zhang, X Qi, F Wang - The International Journal of …, 2015 - Springer
To develop an effective nondestructive evaluation method for the welding quality of the
resistance spot welding, the electrode displacement signal during the resistance spot …

Characterization of the physical stability of a lyophilized IgG1 mAb after accelerated shipping-like stress

S Telikepalli, OS Kumru, JH Kim, SB Joshi… - Journal of …, 2015 - Elsevier
Upon exposure to shaking stress, an IgG1 mAb formulation in both the liquid and lyophilized
state formed subvisible particles. Because freeze-drying was expected to minimize protein …