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One of the most important challenges for a Biotech company before getting the final commercialization of a cell and gene therapy product is the development and production of viral vectors. Over the last decade, we have seen a huge increase in the need for gene therapy protocols and the development of new innovative and high-tech platforms for viral vector production for biotech companies that aspire to play an important role in this market. In order to meet increasing market demand – customized offerings are becoming a necessity.
Lentivirus (LV) and adeno-associated virus (AAV) are the two most common vectors used for the ex-vivo and in-vivo gene therapies. Yet, despite hundreds of biotechnology and engineering studies, standard procedures for large-scale manufacturing of these vectors remains inconsistent.
A New Strategy for a Plug-and-Play Viral Vector Production
As this space grows and new approaches are being developed, the need for a standardized “plug and play” system that meets the unique and custom needs of each developer helps standardize these processes in order to make it easier to manufacture these substances.
Our team at AGC Biologics is working to address this need and provide an efficient and scalable off-the-shelf LV and AAV vector manufacturing processes, able to accelerate the GMP process, reducing PD efforts, time, and costs.
We’ve found we can adapt a plug and play platforms to different therapeutic genes without starting the development from scratch for each product, making the transfer to GMP as fast and smooth as possible. The development activities are performed using the GFP transgene coupled with proprietary packaging plasmids. The flexibility of this approach also offers the possibility to replace the GFP gene with any therapeutic genes through a simple cut-and-sew cloning strategy.
