Nanocarriers

Automate cryo-EM analysis for vaccine & therapy innovation, enhancing LNP & AAV quality with detailed quantification.

Issue

The emergency use authorization of the Pfizer and Moderna vaccines for COVID-19 was a scientific and engineering marvel. In addition to the rapid approval and importance in preventing the spread of the virus, the use of lipid nanoparticles (LNPs) as a delivery vehicle for mRNA has brought to the forefront of pharmaceutical technology a novel mode to deliver therapeutics. With the increasing use of delivery platforms like LNPs, adeno associated viruses (AAVs), and liposomes, the importance of identifying critical quality attributes for product development and regulatory understanding is paramount. cryo-EM imaging is typically used to examine the quality, size, and state of the particles.

However, these studies are often performed at a surface level without any meaningful quantification. Considering the high costs of cryo-EM data collection, the incomplete usage of this data is a shortcoming. When image quantification is performed, it can involve significant manual processing time and development of custom algorithms.

Common Challenges

Costly, underutilized cryo-EM imaging data examined qualitatively.
Time consuming manual analysis.
Missing connection between particle properties, performance, and formulation.

Solution

Our objective is to transform the analytical approaches for cryo-EM imaging data to maximize its full potential. Working with our customers, we are developing automation software solutions to quantify a wide array of attributes far beyond particle size distribution.

We support the entire lifecycle of cryo-EM analysis, including imaging collection and data analysis. Our software platform digiM I2S is designed to tackle the most difficult image processing challenges, including the high signal to noise ratios inherent with cryo-EM. By applying user guided deep learning, we have paved a pathway addressing both accuracy and automation. With particle classification comes the ability to quantify an array of particle attributes including particle size, filled vs empty ratios, and lamellarity. The I2S platform is built to adhere with best practices in 21 CFR Part 11 compliance. We support cryo-EM analysis for liposomes, LNPs, AAVs, and any other types of samples studied with cryo-EM. Our solution is available in both service and software formats.

Our Approach

Quantification of particle attributes such as morphology, lamellarity, and encapsulation efficiency.
Automating particle classification with deep learning workflows.
Data correlation solutions to guide formulation decisions and assess quality.