Lonza and Asimov have entered into a strategic collaboration focused on developing scalable manufacturing approaches for lentiviral vectors (LVVs) intended for emerging in vivo applications. The partnership combines Asimov’s genetic design and cell-line development technologies with Lonza’s capabilities in process development, analytical development, scale-up and good manufacturing practice (GMP) production. The companies aim to bring manufacturing considerations into the development process earlier, potentially reducing the challenges involved in moving LVV programs from early development into clinical and commercial manufacturing.

Lentiviral vectors are being explored for a growing range of therapeutic applications, but conventional manufacturing approaches can present challenges when programs need to scale. Much of the current LVV production landscape relies on transient transfection using multiple plasmids, an approach that can create limitations around scalability and batch-to-batch consistency.

Stable production systems offer an alternative by establishing cell lines capable of producing the vector without relying on repeated transient transfection. Lonza and Asimov will combine their respective technologies and manufacturing expertise to develop stable LVV production strategies designed to improve reproducibility and scalability.

The companies said the approach could be particularly relevant to in vivo LVV programs, where the vector itself is administered as the therapeutic product rather than being used solely as a manufacturing tool for an ex vivo cell therapy. For developers, the collaboration is intended to provide earlier visibility into manufacturing requirements, allowing design and cell-line decisions to be evaluated alongside downstream process and production considerations.

Asimov will contribute its LV Edge system and associated cell-line technologies, while Lonza will provide expertise spanning process development, analytical methods, scale-up and GMP manufacturing. The companies plan to establish a feasibility-first development framework covering several stages of the manufacturing pathway, including transgene optimization, stable cell-line development, process development, analytical characterization, scale-up and CMC readiness.

‘The development of in vivo lentiviral therapies requires design and manufacturing strategy to be considered together from the earliest stages,’ says Daniel Palmacci, Head of Specialized Modalities at Lonza.

Palmacci says combining Asimov’s design and cell-line technologies with Lonza’s manufacturing capabilities could give developers a more integrated route toward clinical and commercial-scale production.

Asimov CEO and co-founder Alec Nielsen says the manufacturing requirements become particularly important when lentiviral vectors are used directly as therapeutic products.

‘In vivo lentiviral therapies turn the vector from a manufacturing reagent into the drug itself,’ Nielsen said, adding that this increases the importance of vector titer, product quality and manufacturing scale.

Beyond scalability, the companies expect stable production approaches to potentially improve manufacturing economics for emerging LVV applications. By establishing reproducible production systems earlier in development, the collaboration is intended to provide a pathway toward more consistent manufacturing and potentially lower cost of goods. The companies said the approaches being developed could also be applicable to ex vivo lentiviral vector programs.

The collaboration reflects a broader effort to connect genetic design and manufacturing strategy earlier in the development cycle. For emerging in vivo LVV therapies, the companies said this integrated approach could help developers identify manufacturability challenges before programs reach later-stage development.

Lonza and Asimov will continue developing the framework across design, cell-line development, process development, analytics, scale-up and GMP manufacturing as the collaboration advances.

For more information, contact: Lonza | Asimov