VIVEbiotech Strengthens Its Position as a Trusted LVV Partner for US Cell & Gene Therapy Developers
From advanced lentiviral vector engineering to FDA-ready GMP manufacturing, VIVEbiotech delivers end-to-end support aligned with US regulatory expectations.
As the US remains a key hub for innovation in cell and gene therapy, VIVEbiotech reinforces its role as a strategic partner for developers seeking high-quality lentiviral vector (LVV) solutions.
With a strong track record supporting international programs, including a growing portfolio of US-based clients, VIVEbiotech offers a fully integrated approach that combines scientific excellence, regulatory expertise, and reliable manufacturing capabilities.
At the core of VIVEbiotech’s value proposition is its deep virology expertise, enabling the design and development of advanced LVVs for both ex vivo and in vivo applications. This scientific foundation supports tailored solutions adapted to each client’s therapeutic needs.
VIVEbiotech’s global reach and solid US presence further strengthen its offering:
- Over 60 international clients, with 30% based in the United States
- Experience supporting multiple US therapeutic programs
- Proven track record in controlled logistics, ensuring compliant LVV shipments while maintaining vector integrity
The company operates under FDA-aligned GMP standards, ensuring the highest levels of quality and regulatory compliance:
- LVV manufacturing supported by FDA-ready documentation
- Participation in programs contributing to FDA-approved therapies
- Audit-ready data packages to streamline regulatory processes
In addition, VIVEbiotech provides dedicated IND support, helping clients accelerate key development milestones:
- Comprehensive CMC documentation for IND-enabling studies
- Rapid response to FDA requests, even under tight timelines
- Continuous support through regulatory interactions
Each project is guided by experienced Project Managers, ensuring efficient execution, transparent communication, and alignment across all development stages.
With its combination of scientific strength, global capabilities, and regulatory readiness, VIVEbiotech positions itself as a partner of choice for US cell and gene therapy developers.
Contact VIVEbiotech to explore your next LVV project.