New analysis methods are needed for sub-visible particles in drug development

At Vironova we’re in the business of electron microscopy-based digital image analysis of sub-visible particles to provide objective and meaningful information during process development and quality control of vaccines and drug/gene delivery systems.

In current advances in drug-delivery, production of vaccines and drug formulation there are many applications for nano-sized particles such as liposomes and virus particles, and these constitute fast growing and promising technologies for new treatment development.

Electron Microscopy (EM) together with image analysis provides unmatched insight into sample purity, particle stability and morphological characteristics. But for routine monitoring of samples during process development this is prohibitively cumbersome technology. Until now, that is. Vironova has tailored powerful transmission electron microscopy (TEM) instrumentation to the biopharmaceutical industry by developing the bench-top, easy to use and highly automated MiniTEMTM electron microscope system.

Why is this important?

Particle characteristics such as purity and integrity can often be directly correlated to efficacy of the final product.

The path to a product is a complex one, from discovery, through development of robust processes to quality control in routine manufacturing. There are many parameters to track and control to avoid undesired sample issues such as aggregation or loss of particle integrity.

In applications where the drug itself is not a particle, nano-sized as well as larger particles may also accidentally appear, for instance when recombinant proteins or monoclonal antibodies aggregate at high concentration, or extrinsic particles are generated through leaching or extraction from disposable technologies.

It is therefore essential to monitor and characterize sub-visible particles of all kinds when assessing sample quality after purification steps or for the understanding of product stability.

Accuracy of results and access to meaningful data that can be used as a basis for development decisions will ultimately speed up development time and save costs.

The combination of visual proof and metric values is not achievable from indirect methods like dynamic light scattering, nor is it feasible with conventional electron microscopy, mainly due to the very long hours of manual work required.

Using MiniTEM, process operators can rapidly and reliably compare samples from different purification steps and gain valuable insight into the stability of different product formulations. Automated analysis performed with MiniTEM provides both morphology and accurate quantitative data that can help speed up process and formulation development.

On 25th April Josefina Nilsson, Head of EM services at Vironova, is speaking on Characterization of Gene therapy vectors, VLPs and whole viruses from pre-formulation through process development to final manufacturing at BioProcess International Europe 2017 in Amsterdam as part of the Vaccine Manufacturing stream.

The talk will explain how accurate, comparative metrics and high quality images, that reveal purity or particle integrity, can easily be obtained at different formulations or purification steps. In addition, for filled-vs-empty analysis of gene therapy vectors, an objective method has been established based on cryo-TEM semi-automated imaging analysis.

We look forward to many fruitful discussions at BioProcess International Europe 2017.

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