Table 2.
Analytical techniques for physical powder characteristics
| Analytical methods | Principles | Consideration | Proteins & peptides | References |
|---|---|---|---|---|
| SEM, TEM | Size, Surface structure, Morphology | Solid | IgG, Lysozyme, Anti-IgE Mab, rhDNase, PTH, Anthrax vaccine, Influenza vaccine | Sarciaux et al. (1999), Jovanovic et al. (2008a, b), Ramezani et al. (2013), Faghihi et al. (2014), Emami et al. (2018a, b), (Jovanovic et al. (2006), Jovanovic et al. (2008a, b), Nuchuchua et al. (2014), (Maa et al. (1999), (Poursina et al. 2015), (Wang et al. 2012), (Maa et al. 2004) |
| BET | Specific surface area | IgG, Anti-IgE Mab, rhDNase | (Jocelyn (1967), Awotwe-Otoo et al. (2015), Maa et al. (1999) | |
| DLS | Hydrodynamic size (1–1000 nm) | Liquid & Suspension, Spherical particles | IgG | Emami et al. (2018a, b) |
| SLS | Size (1–1000 µm) Molecular weight | Suspension | IgG, Anti-IgE Mab, rhDNase, PTH, Anthrax vaccine, Influenza vaccine | Ramezani et al. (2013), Faghihi et al. (2014), Emami et al. (2018a, b), Maa et al. (1999), Poursina et al. (2015), Wang et al. (2012), Maa et al. (2004) |
| Flow imaging microscopy | Size (1–500 µm), Porosity | IgG, Lysozyme | Nuchuchua et al. (2014) | |
| NTA | Concentration, Arithmetic size (30–1000 nm) | IgG, Lysozyme | Nuchuchua et al. (2014) | |
| Karl- Fischer | Residual moisture | IgG, Lysozyme, Anti-IgE Mab, rhDNase, IFN-α-2a, Anthrax vaccine, BSA | Sarciaux et al. (1999), Ramezani et al. (2013), Awotwe-Otoo et al. (2015), Garidel et al. (2015), Jovanovic et al. (2006), Jovanovic et al. (2008a, b), Nuchuchua et al. (2014), Maa et al. (1999), Kumar et al. (2009), Wang et al. (2012), Imamura et al. (2003) | |
| TGA | Residual moisture | Lysozyme | Liao et al. (2004) | |
| Dynamic vapor sorption | Relative humidity (Hygroscopicity) | Solid | Influenza vaccine | Saluja et al. (2010) |
| MDSC solid & liquid state | Crystallinity, Glass transition | Solid & liquid | IgG, Lysozyme, Etanercept, Anthrax vaccine, BSA | Vermeer et al. (2000), Jovanovic et al. (2008a, b), Sahin et al. (2010), Awotwe-Otoo et al. (2015), Jovanovic et al. (2006), Jovanovic et al. (2008a, b), Nuchuchua et al. (2014), Kim et al. (2014), Kim et al. (2016a, b), Wang et al. (2012), Imamura et al. (2003) |
| X-ray diffraction | Crystallinity | Solid | IgG, Lysozyme | Jovanovic et al. (2008a, b), Faghihi et al. (2014), Emami et al. (2018a, b), Jovanovic et al. (2006), Jovanovic et al. (2008a, b) |
| Andersen-cascade impactor, Multi-stage impinge, Twin stage impinge, Next generation impactor | Aerodynamic behavior (FPF, Span) | Solid | IgG, Growth hormone, Anti-IgE Mab, rhDNase, Alkaline phosphatase, Adalimumab | Faghihi et al. (2014), Kim et al. (2016a, b), Maa et al. (1999), Li et al. (2010), Emami et al. (2019), Kim and Kim (2016) |
SEM scanning electron microscopy, TEM transmission electron microscopy, BET Brunauer–Emmett–Teller, DLS dynamic light scattering, SLS static light scattering, NTA Nanoparticle tracking analysis, TGA thermogravimetric analysis, MDSC modulated differential scanning calorimetry, PTH parathyroid hormone, BSA bovine serum albumin, IFN-α-2a interferon-alpha-2a