Josefina Nilsson, Head of EM services at Vironova, is speaking on the characterization of gene therapy vectors, VLPs and whole viruses at BioProcess International Europe 2017. We asked her about nanoparticle based processes and products.
Why are modern techniques needed for a better understanding of nanoparticles in process development and production?
‘There is a need to link product understanding and process control during biopharmaceutical development. There are many parameters to track such as aggregation, changes in morphology and integrity as well as purity of particles/recombinant proteins/monoclonal antibodies. Sub-visible particle characterization is essential when comparing sample quality at different formulations or after various purification steps to achieve final product quality and stability.
We need methods that provide sufficient resolution and detailed information and that are cost-effective and adaptable to the regulatory requirements for routine drug development.
The combination of visual proof and metric values is not achievable from the currently used 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.’
What are the challenges around regulatory expectations for nanoparticle based processes and products?
‘Methods and measurements need to be robust, reproducible, traceable and of course objective. Nanoparticles need to be visualized at high resolution to assess their purity and integrity, amongst other parameters.
The MiniTEM™ system from Vironova precisely provides the high-resolution visualization (through transmission electron microscopy) required. Automation enables accumulation of the large amount of data and analysis of the statistically relevant number of particles that are needed to produce objective measurements.
Having access to this bench-top, easy to use technology on-site and being able to routinely check samples at different phases during development omits the risk of moving too far down process design routes that will not result in desired final product quality.’
Josefina Nilsson is speaking on Day 1 of BioProcess International Europe 2017. Her talk – Characterization of Gene therapy vectors, VLPs and whole viruses from pre-formulation through process development to final manufacturing – is part of the Vaccine Manufacturing stream on 25th April in Amsterdam. To find out more and register for a pass to join 800+ bioprocessing decision makers at BPI Europe, visit the website.