Cellevate Plans Pre-Launch of First Nanofiber Microcarriers for Viral Vector Manufacturing at CPHI Milan

Sweden-based biotech company, Cellevate, which specializes in developing next-generation cell culture systems, announced on Oct. 3, 2024 that it is ready to pre-launch its nanofiber microcarriers for viral vector manufacturing in gene therapy production at CPHI Milan, occurring Oct. 8–10, 2024 in Milan, Italy. According to a company press release, these nanofiber microcarriers are the first to be available on the world market.

The nanofiber microcarriers, marketed as Cellevat3d, are designed to provide up to 60 times more surface area for cell growth than conventional systems, increasing yield and productivity in upstream bioprocessing of gene therapy applications. The microcarriers are engineered for stirred-tank bioreactors and support a wide range of upstream bioprocessing applications in addition to gene therapy, including pluripotent stem cell (PSC) expansion, organoid formation, human embryo kidney (HEK)-based recombinant proteins, and HEK-based vaccine production.

“Scalable, sustainable, and single use, Cellevat3d nanofiber microcarriers closely mimic the human extracellular environment, providing higher cell densities and enhancing yield for viral vector production compared to current standard microcarriers based processes,” said Laura Chirica, PhD, CEO, Cellevate, in the press release.

The company will make Cellevat3d nanofiber microcarriers available for pre-order at CPHI Milan. The product’s official commercial launch is slated for the upcoming BIO-Europe in Stockholm, Sweden, on Nov. 4–6, 2024.

“Our nanofiber microcarriers effectively address the key challenges of low productivity and high manufacturing costs facing the industry. With this pre-launch of Cellevat3d nanofiber microcarriers starter pack at CPHI Milan, we’re excited to provide early access to a completely new category of cell culture systems currently unavailable on the market. Cellevat3d nanofiber-based cell culture systems truly have the potential to transform biomanufacturing for advanced therapies and take a significant step toward making these therapies more accessible to patients,” Chirica said in the press release.

The Cellevat3d technology is a green and sustainable technology innovation, according to the company. The platform allows for industrial-scale production of nanofiber microcarriers—with significantly enhanced surface area for cell growth, reproducibility, customization, and scalability. The company expects these advantages will ultimately lead to an improved biomanufacturing productivity and process economy.

Safety concerns over virus-based vectors are driving investigative attention toward nanotechnology-based non-viral vectors. However, challenges around low transfection rates with nanotech-based non-viral vectors and their poor tissue-targeting ability need to be addressed. Current research suggests that nanocarriers such as non-viral vectors may have a critical role in enhancing gene therapy delivery, especially in the field of pulmonary disease therapy (1). In addition, other non-viral nanocarriers are being investigated as drug delivery systems, including organic-based nanoparticles—such as cellulose, collagen, silk-like polymers, elastin-like protein, silk-elastin-like protein—and inorganic-based nanoparticles (2).

References

1. Wang, H.; Qin, L.; Zhang, X.; Guan, J.; Mao, S. Mechanisms and Challenges of Nanocarriers as Non-Viral Vectors of Therapeutic Genes for Enhanced Pulmonary Delivery. J. Control Release 2022, 352, 970–993. DOI: 10.1016/j.jconrel.2022.10.061
2. Hajebi, S.; Yousefiasl, S.; Rahimmanesh, I.; et al. Genetically Engineered Viral Vectors and Organic-Based Non-Viral Nanocarriers for Drug Delivery Applications. Adv. Healthcare Mater. 2022, 11 (20), 2201583. DOI: 10.1002/adhm.202201583

Source: Cellevate