Viral vectors are vital for the cell and gene therapy industry. However, long production timelines, combined with quality and consistency issues, mean that growing demand is outstripping supply.
The problem is that most vector production technologies and methods were developed for the lab, rather than to support industrial supply, according to Michela Gentile, PhD, cell line manager at Italian contractor, ReiThera.
“Cell and gene therapy developers urgently need better vector production technologies due to capacity and consistency limitations as well as quality and cost concerns,” she says. “Growing industry demand for viral vectors is challenging production capabilities, potentially leading to delays in therapy development.”
Low efficiency is the crux of the problem, notes Gentile, who points out that current production methods often result in low vector yields, batch-to-batch variability, and purity issues. This is a major challenge for cell and gene therapy R&D.
“Such issues can impact therapeutic efficacy and potentially delay approval. Additionally, inefficient production processes drive up costs,” Gentile tells GEN.
This view is based on ReiThera’s experience as a contract developer, producer, and user of viral vectors. However, it is far from a unique opinion in the sector. Most CDMOs working in the space recognize the need for better vector production technologies and have been making efforts to find solutions, Gentile says.
“By improving the efficiency, consistency, and regulatory compliance of vector manufacturing, CDMOs like ours are helping accelerate the development of next-generation cell and gene therapies—making them more accessible to patients worldwide.” She explains, citing ReiCell-AAV, a cell line based on HEK293 developed for AAV production, as an example.
“It is adapted to grow in suspension at high cell densities, which offers two key advantages: faster scale-up to large-scale volumes—up to 2,000 L—and the ability to run upstream processes at high density, resulting in improved AAV productivity,” she continues.
According to Gentile, the cell line routinely achieves yields exceeding 4×10¹⁴ vector genomes per liter (vg/L) across a range of serotypes, which are levels comparable to leading commercial platforms.
“This cell line provides several strategic advantages for customers. Most notably, it is available under highly competitive licensing terms, which significantly lowers the barrier to entry for both early-stage developers and commercial manufacturers,” she says. “Beyond its cost-effectiveness, the platform is supported by a well-defined and validated AAV production process, allowing for faster implementation and shorter development timelines.
“Another key strength lies in its origin,” she continues, adding that “the cell line was developed from passage six of Frank Graham’s original HEK293 vial. This gives it a fully traceable and well-documented lineage—an important asset for ensuring process reliability and meeting regulatory expectations.”
The post Industry Needs More Efficient Viral Vector Production appeared first on GEN - Genetic Engineering and Biotechnology News.
The problem is that most vector production technologies and methods were developed for the lab, rather than to support industrial supply, according to Michela Gentile, PhD, cell line manager at Italian contractor, ReiThera.
“Cell and gene therapy developers urgently need better vector production technologies due to capacity and consistency limitations as well as quality and cost concerns,” she says. “Growing industry demand for viral vectors is challenging production capabilities, potentially leading to delays in therapy development.”
Low efficiency is the crux of the problem, notes Gentile, who points out that current production methods often result in low vector yields, batch-to-batch variability, and purity issues. This is a major challenge for cell and gene therapy R&D.
“Such issues can impact therapeutic efficacy and potentially delay approval. Additionally, inefficient production processes drive up costs,” Gentile tells GEN.
CDMO innovation
This view is based on ReiThera’s experience as a contract developer, producer, and user of viral vectors. However, it is far from a unique opinion in the sector. Most CDMOs working in the space recognize the need for better vector production technologies and have been making efforts to find solutions, Gentile says.
“By improving the efficiency, consistency, and regulatory compliance of vector manufacturing, CDMOs like ours are helping accelerate the development of next-generation cell and gene therapies—making them more accessible to patients worldwide.” She explains, citing ReiCell-AAV, a cell line based on HEK293 developed for AAV production, as an example.
“It is adapted to grow in suspension at high cell densities, which offers two key advantages: faster scale-up to large-scale volumes—up to 2,000 L—and the ability to run upstream processes at high density, resulting in improved AAV productivity,” she continues.
According to Gentile, the cell line routinely achieves yields exceeding 4×10¹⁴ vector genomes per liter (vg/L) across a range of serotypes, which are levels comparable to leading commercial platforms.
“This cell line provides several strategic advantages for customers. Most notably, it is available under highly competitive licensing terms, which significantly lowers the barrier to entry for both early-stage developers and commercial manufacturers,” she says. “Beyond its cost-effectiveness, the platform is supported by a well-defined and validated AAV production process, allowing for faster implementation and shorter development timelines.
“Another key strength lies in its origin,” she continues, adding that “the cell line was developed from passage six of Frank Graham’s original HEK293 vial. This gives it a fully traceable and well-documented lineage—an important asset for ensuring process reliability and meeting regulatory expectations.”
The post Industry Needs More Efficient Viral Vector Production appeared first on GEN - Genetic Engineering and Biotechnology News.