The structure of drug and gene delivery vehicles can affect their drug release functionality as well as their physical stability. Having a comprehensive understanding of these parameters is important in selecting the best delivery carriers, and developing the best performing vaccines and most stable drug formulations. Viruses are complex products making their characterization challenging but crucial. Methods for high-throughput screening of hundreds of samples are required to analyze a range of parameters for optimizing processing conditions and formulations. It is critical to understand and prevent genotoxicity and immune responses, improve gene transfer or editing, and overcome manufacturing and regulatory hurdles.
Development of nanoparticle drug delivery vehicles often involves modifying the main vector to package a gene of interest. These edits aim to improve the structural features and performance of a drug carrier, but must be carefully monitored to control costs and to ensure the maintenance of the stability of the particle.
Cryo-TEM’s high resolution probing of the delivery vehicles in their native state and with nanoscale precision is crucial, especially for soft systems based on virus-like particles. The technique provides:
- Enhanced understanding of particle structure
- Ability to assess size, morphology and encapsulation efficiency
- Validation of the performance of other characterization techniques
- Development and control of critical quality attributes such as thermal stability of virus samples and determining viral particle concentration
- Cryo-TEM with single particle analysis also allows for high resolution structure determination of the viral capsid to support Structure-Based Vector Design (SBVD) providing improved targeting of the vector to the tissue/cell-type of interest and better avoidance of host immune responses through understanding vector recognition by neutralizing antibodies.
- Ability to better characterize the properties of liposomes in terms of size distribution, lamellarity, packaging, stability, and bilayer thickness
- Qualitative and quantitative analysis of liposomal formulations (for example, size, shape, surface modification, lamellarity and encapsulation efficiency) can be very useful, as they may influence biological activity, biodistribution and toxicity and may help further development.
NIS helps you optimize the structure of your gene and drug delivery vehicles.
Imagine gaining a more thorough understanding of the structural characteristics of your formulations earlier in development. NanoImaging Services’ deployment of cryo-TEM makes this possible. We have worked with many leading pharmaceutical and biotech companies to optimize nanoparticles and gene delivery vehicles early during their formulation development. Partnering with us has enabled them to identify potential issues earlier, enabling them to focus on the formulations that are most likely to succeed.