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.
The influence of the substrate temperature during deposition on various semiconducting parameters viz. Hall coefficient (RH), conductivity (σ), Hall mobility (μH), carrier concentration (n) and mean free path (ι0) of vacuum deposited films of Tl2Se and Tl2Te compounds has been studied. Increasing values of RH , σ, μH and ι0 with increasing substrate temperature are explained by a decrease of growth defects of the films with rising substrate temperature.
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