ArticleDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2014
A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process.
Article in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 29 citations in OpenAlex.
- Stabilization of spray-dried monoclonal antibody formulations with polymeric excipients.Journal of pharmaceutical sciences · 2026Article
- Spray-Dried Serum for Inhaled Antiviral Therapy.Pharmaceutics · 2025Article
- Inhalation delivery technology for genome-editing of respiratory diseases.Advanced drug delivery reviews · 2021Review
- Improvement of Drug Delivery Properties of Risperidone via Preparation of Fast Dissolution Tablet Containing Nanostructured Microparticles.Iranian journal of pharmaceutical research : IJPR · 2021Article
- Article
- Drying Technologies for the Stability and Bioavailability of Biopharmaceuticals.Pharmaceutics · 2018Review
- Generation of High Concentrations of Respirable Solid-Phase Aerosols from Viscous Fluids.Aerosol science and technology : the journal of the American Association for Aerosol Research · 2018Article
- Optimization and characterization of spray-dried IgG formulations: a design of experiment approach.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2017Article
- Production of specific IgY Helicobacter pylori recombinant OipA protein and assessment of its inhibitory effects towards attachment of H. pylori to AGS cell line.Clinical and experimental vaccine research · 2015Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe main concern in formulation of antibodies is the intrinsic instability of these labile compounds. To evaluate the physicochemical stability of antibody in dry powder formulations, physical stability of IgG1 and a monoclonal antibody (trastuzumab) during the spray drying process was studied in a parallel study and the efficacy of some sugar based excipients in protection of antibodies was studied.
resultsThe SDS-PAGE analysis showed no fragmentation of antibodies after spray drying in all formulations. The secondary structure of antibodies contained 40.13 to 70.19% of β structure in dry state. Also, CD spectroscopy showed the similar secondary structure for trastuzumab after reconstitution in water. ELISA analysis and cell culture studies were conducted in order to evaluate bioactivity of monoclonal antibody. Formulations containing combination of excipients provided maximum tendency of trastuzumab to attach to the ELISA antigen (86.46% ± 2.3) and maximum bioactivity when incubated with SKBr3 cell line (the cell viability was decreased to 65.99% ± 4.6). Incubation of formulations with L929 cell line proved the biocompatibility of the excipients and non-toxic composition of formulations.
conclusionThe IgG1 and trastuzumab demonstrated similar behavior in spray drying process. The combination of excipients containing trahalose, hydroxypropyl beta cyclodextrin and beta cyclodextrin with proper ratio improved the physical and chemical stability of both IgG1 and monoclonal antibody.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.