Optimization and characterization of spray-dried IgG formulations: a design of experiment approach

Faghihi, Hooshang; Najafabadi, Abdolhosein Rouholamini; Vatanara, Alireza

doi:10.1186/s40199-017-0187-8

Cited by 20 publications

(9 citation statements)

References 34 publications

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“…Spray drying is a new technique for processing antibody dry particles. Pure antibody solutions, on the other hand, have been demonstrated to significantly agglomerate during this process (Faghihi et al 2017 ). Such destabilisation is rationally linked to shearing stress in the nozzle, heat stress during drying, and surface adsorption of contaminants.…”

Section: Choice and Constraints Of Drug Delivery Devicementioning

confidence: 99%

Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections

Parray

Shukla

Perween

et al. 2021

Appl Microbiol Biotechnol

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The route of administration of a therapeutic agent has a substantial impact on its success. Therapeutic antibodies are usually administered systemically, either directly by intravenous route, or indirectly by intramuscular or subcutaneous injection. However, treatment of diseases contained within a specific tissue necessitates a better alternate route of administration for targeting localised infections. Inhalation is a promising non-invasive strategy for antibody delivery to treat respiratory maladies because it provides higher concentrations of antibody in the respiratory airways overcoming the constraints of entry through systemic circulation and uncertainity in the amount reaching the target tissue. The nasal drug delivery route is one of the extensively researched modes of administration, and nasal sprays for molecular drugs are deemed successful and are presently commercially marketed. This review highlights the current state and future prospects of inhaled therapies, with an emphasis on the use of monoclonal antibodies for the treatment of respiratory infections, as well as an overview of their importance, practical challenges, and clinical trial outcomes. Key points • Immunologic strategies for preventing mucosal transmission of respiratory pathogens. • Mucosal-mediated immunoprophylaxis could play a major role in COVID-19 prevention. • Applications of monoclonal antibodies in passive immunisation.

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Section: Choice and Constraints Of Drug Delivery Devicementioning

confidence: 99%

Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections

Parray

Shukla

Perween

et al. 2021

Appl Microbiol Biotechnol

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“…An alternative to SPD, spray freeze drying (SFD) process which involves flash freezing of IgG1 in liquid nitrogen followed by bulk freeze drying can be explored. Faghihi et al 39 and Yowa et al 40 describe this process as more subtle for proteins and is commercially viable option, but less studied in manufacturing of highconcentration antibody formulations.…”

Section: Spray Drying (Spd) and Spray Freeze Drying (Sfd) Of Igg1mentioning

confidence: 99%

Comparison of Strategies in Development and Manufacturing of Low Viscosity, Ultra-High Concentration Formulation for IgG1 Antibody

Deokar

Sharma

Mody

et al. 2020

Journal of Pharmaceutical Sciences

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Monoclonal antibodies requiring higher doses for exerting therapeutic effect but having lower stability, are administered as dilute infusions, or as two (low concentration) injections both resulting in reduced patient compliance. Present research summarizes impact of manufacturing conditions on ultra-high concentration (≥150mg/mL) IgG1 formulation, which can be administered as one subcutaneous injection. IgG1 was concentrated to ∼200mg/mL using tangential flow filtration (TFF). Alternatively, spray dried (SPD) and spray freeze dried (SFD) IgG1, was reconstituted in 30%v/v propylene glycol to form ultra-high concentration (∼200 mg/mL) injectable formulation. Reconstituted, SPD and SFD IgG1 formulations, increased viscosity beyond an acceptable range for subcutaneous injections (<20 cP). Formulations developed by reconstitution of SPD IgG1, demonstrated increase in high and low molecular weight impurities, at accelerated and stressed conditions. Whereas, the stability data suggested reconstituted SFD IgG1 was comparable to control IgG1 formulation concentrated by TFF. Also, formulation of IgG1 diafiltered with proline using TFF, reduce viscosity from ∼21.9 cP to ∼11 cP at 25°C and had better stability. Thus, conventional TFF technique stands to be one of the preferred methods for manufacturing of ultra-high concentration IgG1 formulations. Additionally, SFD could be an alternative method for long term storage of IgG1 in a dry powder state.

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“…of the biological matrix, particularly immunoglobulins (Niewold et al, 2007;Gikanga et al, 2015;Faghihi et al, 2017), which is of vital importance in products containing antibodies that must be preserved, such as serum, plasma, milk, and colostrum.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of the spray-drying treatment to inactivate the bovine leukemia virus in bovine colostrum

Lomónaco

Sowul

Gutiérrez

et al. 2020

Journal of Dairy Science

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Previous studies have shown the presence of bovine leukemia virus (BLV) in colostrum and milk of naturally infected cows. The relationship between virus or provirus and specific antibodies in these secretions is particular to each infected cow and will probably determine whether the consumption of colostrum or milk from these naturally infected dams provides an infective or a protective effect in recipient calves. Our recent findings suggest that this issue is a key point in BLV transmission in very young calves. Based on this, the aim of the present study was to determine the effect of the spray-drying treatment of colostrum on BLV infectivity. The treatment was done on scale-down conditions, using fresh colostrum from BLV-negative cows spiked with infective BLV. Residual infectivity was tested in susceptible lambs. Lambs inoculated with colostrum spiked with BLV-infected cells or cell-free BLV showed evidence of infection 60 d after inoculation, whereas none of the lambs inoculated with spraydried colostrum showed evidence of infection 60 d after inoculation. These results provide direct evidence that the experimental spray-drying process used in this study was effective in inactivating infectious BLV in colostrum. These findings suggest that the risk for BLV transmission could be reduced if milk and colostrum were treated by spray-drying prior to consumption in dairy facilities. The effect of spray-drying on the functional properties and stability of the antibodies present in colostrum under long-term storage should be further investigated.

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Optimization and characterization of spray-dried IgG formulations: a design of experiment approach

Cited by 20 publications

References 34 publications

Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections

Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections

Comparison of Strategies in Development and Manufacturing of Low Viscosity, Ultra-High Concentration Formulation for IgG1 Antibody

Efficacy of the spray-drying treatment to inactivate the bovine leukemia virus in bovine colostrum

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