Physicochemical & Biological Assessment of Lyophilized Trastuzumab Formulation Containing Trehalose & Peg: A Central Composite Design
S Dehghani Tafti - … & Biological Assessment of Lyophilized Trastuzumab … - papers.ssrn.com
The current study aimed to find the best combination of trehalose and polyethylene glycol
4000 (PEG4000) in Trastuzumab lyophilized formulation. Trehalose and PEG4000 varied …
4000 (PEG4000) in Trastuzumab lyophilized formulation. Trehalose and PEG4000 varied …
[HTML][HTML] Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures
M Paul, A Astier, V Vieillard - GaBI J, 2018 - gabi-journal.net
Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6
(Herzuma®, Biogaran) in vials under various storage conditions; after reconstitution of the …
(Herzuma®, Biogaran) in vials under various storage conditions; after reconstitution of the …
Freeze thaw and lyophilization induced alteration in mAb therapeutics: trastuzumab as a case study
R Dash, AS Rathore - Journal of Pharmaceutical and Biomedical Analysis, 2021 - Elsevier
Long-term stability of therapeutic monoclonal antibody (mAb) products is necessary for their
successful commercialization. Freeze-thaw (F/T) operations are often performed for a mAb …
successful commercialization. Freeze-thaw (F/T) operations are often performed for a mAb …
A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process
Background The main concern in formulation of antibodies is the intrinsic instability of these
labile compounds. To evaluate the physicochemical stability of antibody in dry powder …
labile compounds. To evaluate the physicochemical stability of antibody in dry powder …
The effect of freeze-dried antibody concentrations on its stability in the presence of trehalose and hydroxypropyl-β-cyclodextrin: A box–behnken statistical design
The present study aimed at preparation and optimization of stable freeze-dried
immunoglobulin G (IgG) applying proper amount of antibody with efficient combination of …
immunoglobulin G (IgG) applying proper amount of antibody with efficient combination of …
Implementation of Design of Experiments (DOE) for Optimization of Feeding Strategy and Glyco-Engineering of Trastuzumab Biosimilar
R Mahboudi, S Samavat, A Afrah, M Khorshidtalab… - bioRxiv, 2019 - biorxiv.org
Fed-batch cell culture is the most commonly used process for antibody production in
biopharmaceutical industries. Basal media, feed, feeding strategy and glycan structures are …
biopharmaceutical industries. Basal media, feed, feeding strategy and glycan structures are …
Focused physicochemical stability study of reconstituted trastuzumab biosimilar SB3 (Ontruzant®) stored in the original vials over 28 days
L Knoll, J Thiesen, I Krämer - Pharmaceutical Technology in Hospital …, 2024 - degruyter.com
Abstract Objective Trastuzumab biosimilar SB3 (Ontruzant®), a HER2 binding monoclonal
antibody, is available as powder for concentrate for solution for infusion. According to the …
antibody, is available as powder for concentrate for solution for infusion. According to the …
Amino Acid‐Based Advanced Liquid Formulation Development for Highly Concentrated Therapeutic Antibodies Balances Physical and Chemical Stability and Low …
K Kemter, J Altrichter, R Derwand… - Biotechnology …, 2018 - Wiley Online Library
To develop highly concentrated therapeutic antibodies enabling convenient subcutaneous
application, well stabilizing pharmaceutical formulations with low viscosities are considered …
application, well stabilizing pharmaceutical formulations with low viscosities are considered …
Formulating monoclonal antibodies as powders for reconstitution at high concentration using spray-drying: Trehalose/amino acid combinations as reconstitution time …
J Massant, S Fleurime, M Batens… - European Journal of …, 2020 - Elsevier
To increase their stability, therapeutic (or monoclonal) antibodies (mAbs) are often
formulated as solids by using a variety of drying techniques, eg freeze-drying, spray-drying …
formulated as solids by using a variety of drying techniques, eg freeze-drying, spray-drying …
Physiochemical stability of diluted trastuzumab infusion solutions in polypropylene infusion bags
J Kaiser, I Kramer - International Journal of Pharmaceutical Compounding, 2011 - ijpc.com
The purpose of this study was to determine the physicochemical stability of ready-to
administer trastuzumab infusion solutions in 0.9% sodium chloride solution as the vehicle …
administer trastuzumab infusion solutions in 0.9% sodium chloride solution as the vehicle …