Podcast viral vector manufacturing
Transmission electron microscopy in analysing viral and non-viral vectors for gene therapy is the subject of our latest podcast and blog article by Vanessa Carvalho, Senior scientist at Vironova AB. Our customers working with gene therapy and AAV products have various questions but the most common question is the need to measure the percentage of full capsids present in the sample.
Gene therapy is a young field where establishment of production protocols is still in its infancy. As more and more projects move into later clinical phases and manufacturers need to develop commercial manufacturing processes they face new challenges.
Moving from laboratory scale to larger scale means introducing changes that may have an impact on the purity of the sample during the downstream process. Optimizing process steps to avoid impurities that affect final product quality and patient safety can be a daunting task.
Having access to a combination of data from different reliable analytical solutions is the key to success. TEM will give an image of what is actually in the sample and the subsequent automated image analysis converts the structures in the image to accurate metric data that reflect the portion of different contaminants in relation to intact particles in the sample.
Read more and listen to the podcast at Cell and Gene Therapy Insights.