VintaBio™, a technology-forward company, announced that it has filed provisional patents with the US Patent Office describing its novel approach to manufacturing biotherapeutics using adherent culturing methods in a small-scale process.

Improving upon the adherent manufacturing approaches used for FDA-approved gene therapies, such as Zolgensma™ and Luxturna™, VintaBio has designed a purpose-built process that reduces large operational footprints that restrict scalability. VintaBio’s process leverages proprietary technology, tools and methods ideally suited for high density culturing of adherent cells in a single-use benchtop bioreactor system. The process eliminates the need for plastic bottles, flasks and other flatware - the result is a high-intensity manufacturing process that delivers the ability to rapidly scale-up in any part of the world.

The first applications for this novel approach have successfully been demonstrated in producing AAV viral vector gene therapies using an HEK293 cell line for clients. Batch data using VintaBio’s process indicates that the percent full capsids generated at harvest is greater than 60% and more than 95% at final purification. The total process recovery rate using VintaBio’s platform is approximately 60%.

The team is currently underway demonstrating proof of concept in other viral vectors including lentivirus, adenovirus and HSV.

Having worked on manufacturing strategies for several other FDA-approved gene therapies, the founders at VintaBio were committed to designing a faster and more scalable manufacturing process for getting therapies to patients. Leveraging their shared experiences and intimate working knowledge of the critical manufacturing challenges, they worked to design a purpose-built process that would alleviate the scalability and productivity limitations of adherently cultured biotherapeutics. Since designing the initial process, VintaBio has continued to build on its working knowledge to further optimize performance and quality through measures such as pooling and perfusion. While successfully executed for AAV gene therapies, the use of VintaBio’s process in vaccines, biotherapeutics and other cell and gene therapies is currently being evaluated.

“The growing interest in our platform is a strong indication that the industry is keen to find better ways to get critical therapies to patients. Not only that, but they also understand that VintaBio fills a critical gap in the current ways of working. Our recent scientific and commercial accomplishments have us poised to take on these challenges and continue to generate strong market demand for other applications – well beyond our initial proof of concept. The applications for our platform are far-reaching and the team at VintaBio is well positioned to get us there,” said David Radspinner, PhD, CEO of VintaBio.

The innovative approach to manufacturing therapeutics developed by VintaBio paves the way for enhanced scalability and a faster path to market for biotherapeutics - reducing the space and equipment demand by 80% and shortening the development time from 18 months to about 3-6 months.