The Question Of Quality: Digging Into Manufacturing Priorities For Viral Vectors

Cell and gene therapies have the potential to revolutionize medicine by offering curative, one-time treatments for monogenic diseases. However, delivering these therapies at scale presents significant challenges, particularly in viral vector manufacturing. Issues such as quality control, scalability, supply chain complexities, and regulatory readiness require strategic and innovative solutions.

In a recent webinar, participants identified quality control capabilities as the top concern in viral vector manufacturing, with 40% citing it as their primary challenge. Other major concerns included supply chain complexities, regulatory readiness, and securing manufacturing capacity. These insights highlight the industry's focus on robust analytical methods, standardized assays, and resilient supply chains to ensure consistent product quality.

When selecting a contract manufacturing organization (CMO) partner, survey respondents ranked quality as the most important factor, followed by expertise, supply chain robustness, flexibility, and cost. Novartis addresses these challenges through strategic internalization, enhancing scheduling flexibility and cost efficiency.