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Collection: Analytical Assays and Testing (GMP and Preclinical)
Analytical testing and assays play a crucial role in characterizing and evaluating liposomes, lipid nanoparticles (LNPs), and nanoparticle drug products. Here are some common analytical techniques used in this context:
1. Particle size and distribution analysis: Techniques such as dynamic light scattering (DLS) or nanoparticle tracking analysis (NTA) are employed to determine the size distribution of liposomes and LNPs. These methods provide information about the average particle size, polydispersity index, and size range of the nanoparticles.
2. Zeta potential measurement: Zeta potential is the electrokinetic potential at the particle surface and is an indicator of the stability of liposomes and LNPs. Laser Doppler electrophoresis or electrophoretic light scattering methods are used to measure zeta potential, which helps assess the colloidal stability of the nanoparticles.
3. Encapsulation efficiency: This assay determines the amount of drug or cargo encapsulated within the liposomes or LNPs. Various techniques, including centrifugation, ultrafiltration, or dialysis, followed by quantification of the free drug in the supernatant or filtrate, are used to calculate the encapsulation efficiency.
4. Drug release studies: These studies assess the release kinetics of the drug from liposomes or LNPs. Different release methods can be employed, such as dialysis, membrane diffusion, or dissolution testing, to mimic the conditions in which the nanoparticles will be administered.
5. Stability testing: Stability studies are conducted to assess the physical and chemical stability of liposomes and LNPs over time. This includes evaluating particle size, zeta potential, drug encapsulation, and integrity of the lipid bilayer under various storage conditions, such as temperature, humidity, and light exposure.
6. Morphological characterization: Techniques like transmission electron microscopy (TEM) or scanning electron microscopy (SEM) provide high-resolution imaging of liposomes and LNPs, allowing assessment of their size, shape, and structural integrity.
7. Drug content determination: This assay quantifies the amount of drug present in the liposomes or LNPs. Techniques such as high-performance liquid chromatography (HPLC), UV-Vis spectroscopy, or mass spectrometry (MS) are commonly used for drug content analysis.
8. In vitro release and uptake studies: These studies evaluate the release of drugs from liposomes or LNPs in simulated physiological conditions and their uptake by target cells. Various cell-based assays, including flow cytometry or fluorescence microscopy, can be employed to measure drug release and cellular uptake.
9. Toxicity assessment: Liposomes, LNPs, and nanoparticle drug products need to undergo toxicity evaluation. Assays such as cell viability assays (MTT, XTT), cell membrane integrity assays (LDH release), or in vivo toxicity studies are conducted to assess the safety profile of the nanoparticles.
It is important to note that the selection of specific analytical tests and assays may vary depending on the specific formulation, intended application, and regulatory requirements.
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