Gene Therapy has immense potential to revolutionize the treatment of diseases that are currently considered incurable or poorly managed with conventional therapies. It is particularly promising for genetic disorders, certain cancers, and infection diseases.
It aims to treat or cure genetic disorders by inserting, altering, or removing defective genes within a patient’s cells. This often involves integrating genetic material into the patient's cells for ongoing protein production to provide long-term or permanent effects.
Enabling researchers to move their discoveries in this field out of the lab and into production has a significant impact on human health. At VILS, we also understand that when you are developing therapies and technologies that have never existed before, the faster your discoveries can be applied, the faster they can start improving – and in some cases saving – people’s lives. That is why we at VILS share your sense of urgency.
In some cases, of course, it may be better to delay your investments until more solid scientific data is available, followed by an accelerated path to operational readiness. Whichever path you choose, we are ready to assist and are known for delivering solutions quickly.
Key challenges: Manufacturing Scalability and Costs
For all the promise of gene therapies, producing them, especially at commercial scale, is complex and expensive, limiting affordability and access. Designing facilities for such processes as viral vector production, purification, and quality control are resource intensive.
Complex and evolving regulations compound the challenge and can make regulatory pathways something of a moving target. This requires significant expertise to address, increases the time and cost of development, and can delay patient access.
An industry-wide shortage of trained personnel with expertise in gene editing, viral vector production, and regulatory compliance further hampers development, innovation, and manufacturing efficiency. Scaling up for larger patient populations, especially for conditions requiring systemic delivery, also is a major obstacle.
For all these reasons, the expertise of VILS process architects and engineers can be a crucial contribution to designing, building and getting regulatory approval for your facility. Our experience includes:
- The world’s first GMP viral vector facility, for Novasep, in 2017.
- Our first large -scale viral vector facility, for Exothera, in 2020.
- Our first EPC to design and build a large -scale viral vector facility for Batavia, in 2022.
We always base our facility designs on a thorough understanding of our clients’ processes and an equally thorough understanding of applicable regulations. We also align our proposals to the requirements of our clients’ growth plans.
The result is always an efficient facility that is the right size at the right time for the business case. And it is always based on a practical, streamlined process that includes everything that is essential and nothing that isn’t.
Maximum impact on people’s lives
At VILS, we believe that our process- and business-based approach to designing a facility and gaining regulatory approval is the fastest, most efficient way forward. Breakthrough ideas will have more impact on more people’s lives sooner, with more availability of more therapies for more patients.
It’s why you do the work you do. And why we share your passion for your work: Because it matters.
Learn more about the VILS approach, which starts from your research and business needs
Learn more about our project references.