Lonza, Asimov team to advance in vivo lentiviral vector manufacturing

The collaboration aims to improve the scalability and reproducibility of lentiviral vector production for in vivo therapies.

Switzerland-headquartered contract development and manufacturing organization (CDMO) Lonza and Asimov, a Boston-based synthetic biology company, have entered a strategic collaboration to develop scalable manufacturing approaches for lentiviral vectors (LVVs) used in emerging in vivo therapies.

The collaboration combines Asimov’s LV Edge cell line technologies with Lonza’s process development, analytics, scale-up, and GMP manufacturing capabilities. The companies said the integrated approach is intended to bring manufacturing considerations into development earlier and establish a more direct path to clinical and commercial production.

Current LVV manufacturing commonly relies on multi-plasmid transient transfection, which can create challenges related to scalability and production consistency, according to the announcement. Stable production systems could provide more scalable and reproducible manufacturing approaches for LVVs, including vectors administered directly to patients in vivo.

Asimov has previously expanded access to its LV Edge technology through a licensing agreement with AGC Biologics at the CDMO’s Cell and Gene Center of Excellence in Milan, Italy. Announced in January, the agreement enabled AGC Biologics to offer a single-plasmid lentiviral vector manufacturing approach using Asimov’s packaging cell line. According to the companies, the system was evaluated at the Milan site using clinically relevant genes of interest before being made available to customers globally.

Under the new collaboration, Asimov and Lonza will work on program-specific stable production strategies intended to address the titer, product quality, scalability, and consistency requirements of in vivo LVV programs. The same manufacturing approaches also could support ex vivo applications, according to the companies.

“The development of in vivo lentiviral therapies requires design and manufacturing strategy to be considered together from the earliest stages,” Daniel Palmacci, head of Specialized Modalities at Lonza, said in a statement. “By combining Asimov’s design and cell line technologies with our process development and GMP manufacturing expertise, we can bring manufacturability considerations earlier into development and provide customers with a more connected path towards scalable clinical and commercial manufacturing.”

The collaboration will span transgene optimization, cell line development, process development, advanced analytics, scale-up, GMP manufacturing, and chemistry, manufacturing and controls (CMC) readiness. The companies said the approach is intended to help developers evaluate manufacturing feasibility earlier and potentially reduce manufacturing costs as programs advance.

The partnership adds to Lonza’s broader investment in manufacturing capacity and technology. In September, the company announced plans to build a large-scale commercial spray-drying facility at its Bend, Oregon site. The facility will include two commercial-scale spray-drying units and is expected to begin operations in 2029, adding U.S. capacity for spray-dried pharmaceutical formulations.

Lonza said the Bend project will complement existing clinical-scale particle-engineering capabilities and support customers transitioning spray-dried dispersion programs into commercial manufacturing.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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