By Ratish Krishnan and David Loong, Senior Strategy Consultants for Novel Modalities Bioprocessing, MilliporeSigma
As advances in science and technology extend the application of gene therapies from ultra-rare diseases to more widespread diseases, the possibilities of what this field can accomplish are expanding rapidly. Viral vectors are the most common gene-delivery mechanism and to date, a total of eight viral-vector-based therapies have already been approved by the FDA, with 25 viral-vector therapeutics in late-stage development and another 120 in Phase II trials as of February 2022.1 This growing pipeline means that quick and efficient scale-up of viral vector production is more important than ever, with more technology providers throwing their hat in the arena as potential partners for biomanufacturers pursuing these revolutionary treatments.
While the goal is often to reduce the complexity of solution provider relationships, the gene therapy manufacturing template is still evolving and workflows can include 10 or more unit operations that require several different types of products and technologies. As a result, a single technology provider will likely be able to offer superior solutions and guidance in some areas but not all, which could lead to a suboptimal process. And as the industry continues to navigate lessons learned from a pandemic that exposed the cracks in the pharmaceutical supply chain, designing a commercialization strategy around supply from one vendor could leave a biotech vulnerable to shortages and costly delays. Thus, working with multiple partners and where their solutions compliment your process best may be the most effective and efficient solution in this evolving area.
Nevertheless, creating a strategy that relies on multiple partners comes with its own challenges. Download the full article to learn how to complete a comprehensive evaluation of your partner(s) to determine if they are truly committed to understanding your needs and are indeed capable of developing a process to fit those needs.