This Research Topic is part of our Editor's Feature for the month of December in acknowledgement of the timeliness of the collection's thematic focus.
When in the late 2010s two breakthrough gene therapy products, Luxturna and Zolgensma, were approved, a deep interest of industrial and academic stakeholders in gene therapy was ignited. Both products are delivered via viral vectors, highlighting research around these delivery vehicles. The race against the COVID-19 pandemic was and is a pivotal point for shining a spotlight on the previously less regarded progress in vaccine research and development, especially for infectious diseases. With the 2021 approval of a virus-like particle (VLP)-based vaccine against Malaria, the first chimeric VLP is now part of the global vaccination portfolio. All three events unite the fact that complex biotechnological products provided a medical breakthrough. However, technological advances for the development and manufacturing of these exceptional products lack behind. Generating knowledge around viral delivery vehicles and vaccine development and manufacturing is the key to the success of these new technologies.
A lack of tailored biopharmaceutical processing technologies for viral vectors and virus-like particles (VLPs) is a potential pitfall for novel therapies utilizing these complex biotechnological products. One exemplary, well-known problem is both the preparative and analytical separation of full, empty, and partially full adeno-associated viral capsids in viral vector development. Comparable problems exist related to the purification and characterization of other viruses and VLPs, including processes with low recovery, high variability and a lack of appropriate quantitative analytical methods. Recent advances have shown the promise of novel chromatographic resins, sophisticated utilization of filtration technologies, and the application of a wide array of analytical techniques, including process analytical technology. This research topic aims to tackle the above-mentioned challenges by collecting research on novel analytical methods and technologies, the development of flexible purification and manufacturing processes for these complex products, or the critical review of current development efforts for viral vectors and VLPs.
Areas to be covered in this Research Topic may include, but are not limited to:
• Novel strategies for processing of viral vectors and VLPs
• Steps toward platform process technology for viral vectors and VLPs
• Development of analytical methods and technologies for quantitation of viral vectors and VLPs as well as their cargo and related impurities
• Critical review of current development and manufacturing strategies for viral vectors and VLPs
This Research Topic is part of our Editor's Feature for the month of December in acknowledgement of the timeliness of the collection's thematic focus.
When in the late 2010s two breakthrough gene therapy products, Luxturna and Zolgensma, were approved, a deep interest of industrial and academic stakeholders in gene therapy was ignited. Both products are delivered via viral vectors, highlighting research around these delivery vehicles. The race against the COVID-19 pandemic was and is a pivotal point for shining a spotlight on the previously less regarded progress in vaccine research and development, especially for infectious diseases. With the 2021 approval of a virus-like particle (VLP)-based vaccine against Malaria, the first chimeric VLP is now part of the global vaccination portfolio. All three events unite the fact that complex biotechnological products provided a medical breakthrough. However, technological advances for the development and manufacturing of these exceptional products lack behind. Generating knowledge around viral delivery vehicles and vaccine development and manufacturing is the key to the success of these new technologies.
A lack of tailored biopharmaceutical processing technologies for viral vectors and virus-like particles (VLPs) is a potential pitfall for novel therapies utilizing these complex biotechnological products. One exemplary, well-known problem is both the preparative and analytical separation of full, empty, and partially full adeno-associated viral capsids in viral vector development. Comparable problems exist related to the purification and characterization of other viruses and VLPs, including processes with low recovery, high variability and a lack of appropriate quantitative analytical methods. Recent advances have shown the promise of novel chromatographic resins, sophisticated utilization of filtration technologies, and the application of a wide array of analytical techniques, including process analytical technology. This research topic aims to tackle the above-mentioned challenges by collecting research on novel analytical methods and technologies, the development of flexible purification and manufacturing processes for these complex products, or the critical review of current development efforts for viral vectors and VLPs.
Areas to be covered in this Research Topic may include, but are not limited to:
• Novel strategies for processing of viral vectors and VLPs
• Steps toward platform process technology for viral vectors and VLPs
• Development of analytical methods and technologies for quantitation of viral vectors and VLPs as well as their cargo and related impurities
• Critical review of current development and manufacturing strategies for viral vectors and VLPs