VIVEbiotech and Zelluna have unveiled details of a long-running collaboration focused on GMP lentiviral vector manufacturing for Zelluna’s allogeneic T cell receptor-based natural killer cell therapy platform. The partnership, which has been ongoing since 2018, supports Zelluna’s work on off-the-shelf therapies for solid tumors, including its lead MAGE-A4-targeting candidate, ZI-MA4-1, which is planned to enter clinical trials in 2026.
To find out more about the collaboration – and the broader manufacturing challenges involved in developing off-the-shelf cell therapies for solid tumors – we spoke with Jon Alberdi, CEO of VIVEbiotech.
What are the main manufacturing challenges associated with lentiviral vectors for allogeneic cell therapies?
One of the key challenges in manufacturing lentiviral vectors for allogeneic cell therapies is achieving a combination of high purity, consistent quality, and scalability. As these therapies rely on producing large batches upfront to support multiple patients, the manufacturing process must be robust and reproducible at increasing scales without compromising vector quality.
In addition, lentiviral vectors must be thoroughly characterized to ensure safety and performance, which places high demands on process control, analytics, and GMP compliance. Designing processes that can reliably deliver large volumes of high-quality vector is therefore critical to enabling true off-the-shelf cell therapy models.
Why is lentiviral vector performance so important to the viability of “off-the-shelf” therapies?
Lentiviral vector performance has a direct impact on the overall feasibility of off-the-shelf therapies. Higher-performing vectors enable efficient gene transfer at lower doses, which contributes to improved safety profiles and more predictable manufacturing outcomes.
As allogeneic cell therapies move toward broader patient populations and indications with higher incidence rates, it becomes increasingly important to rely on well-characterized, high-performing vectors. Consistent vector performance supports scalable manufacturing, facilitates regulatory approval, and ultimately helps ensure that these therapies can be delivered reliably and sustainably to patients.
How do the manufacturing demands differ when developing cell therapies for solid tumors rather than blood cancers?
From a manufacturing standpoint, the growing focus on solid tumors brings an increased need for process reliability and consistency, as developers explore more complex therapeutic approaches and indications with significant unmet medical need.
While solid tumors have historically been more challenging to treat, advances in gene and cell therapy technologies are opening new opportunities. For manufacturers, this evolution underscores the importance of flexible, scalable platforms that can support innovation while maintaining GMP standards and reproducibility as therapies progress toward the clinic. In addition, the use of stable cell lines is a key contributor to achieving this goal.
How is VIVEbiotech’s collaboration with Zelluna helping to address some of these manufacturing challenges?
The strength of the collaboration between VIVEbiotech and Zelluna lies in the clear complementarity of expertise. Zelluna can focus fully on advancing its TCR-NK cell therapy platform, while VIVEbiotech provides a reliable, scalable, and GMP-compliant lentiviral vector manufacturing platform.
Our established processes enable fast turnaround times, scalability without loss of quality, and high reproducibility, ensuring that Zelluna receives consistent vector supply to support development milestones. This division of responsibilities allows both parties to operate efficiently within their core areas, accelerating progress toward clinical readiness.
What needs to happen next to make “off-the-shelf” solid tumor therapies more widely accessible to patients?
The field is moving in the right direction. As more companies adopt allogeneic approaches and gain experience with these technologies, collective knowledge around manufacturing processes will continue to grow, leading to improved yields, greater efficiency, and reduced costs.
From a manufacturing perspective, continued investment in scalable platforms, automation, and streamlined quality control will be essential. At VIVEbiotech, we are actively incorporating automation across manufacturing, quality control, and documentation workflows, with the goal of supporting cost-effective production and helping make off-the-shelf cell therapies more accessible to patients worldwide.
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