We are a GMP-certified CDMO focused exclusively on lentiviral vector manufacturing, with:

• + 50 clients in the US, Europe, Asia and Australia
• + 10 years of lentiviral vectors experience
• + 180 batches manufactured in bioreactor

Our lentiviral vectors have been used in clinical trials worldwide, with some customers reporting full patient recoveries.

Contact us today! https://www.vivebiotech.com/en/contact/

We support projects from early research and drug discovery through preclinical studies, clinical phases I–III, and commercial-scale manufacturing, ensuring quality, reproducibility and scalability.

Yes. VIVEbiotech has held the GMP certification since 2017. Currently operates under FDA and EMA standards. We are authorized to release GMP lentiviral vectors for ex vivo and in vivo use and have successfully passed more than 30 international client audits.

At VIVEbiotech, every GMP batch is released by our own Qualified Person (QP), ensuring full compliance with EMA and FDA guidelines and guaranteeing the highest quality standards throughout the manufacturing process.

We apply strict quality controls to ensure purity, potency, and safety. Our QC and QA teams manage analytical methods and regulatory documentation for IMPD and IND submissions, supporting successful clinical trials globally.

Our facilities include:

• Seven GMP cleanrooms
• Capacity for up to 60 lentivirus batches in reactor per year
• 3,000 m² dedicated exclusively to lentiviral vector development and manufacturing.

We have optimized our platform to deliver high titers and cost-effective production.

We offer end-to-end lentiviral vector CDMO services:

• Technology transfer
• Process development & optimization
• R&D manufacture in bioreactors
• Engineering runs
• GMP batches
• Fill/finish
• Stability studies: long-term and in-use
• Regulatory support (IND/IMPD)

VIVEbiotech offers a broad range of production scales for lentiviral vector manufacturing, from small-scale R&D batches in bioreactor to development, engineering and full GMP runs. Our platform currently includes production scales of 4.8, 10, 30 and 200 m², with a 600 m² scale to be added shortly. This flexibility allows us to support projects from early discovery through clinical and commercial supply, ensuring process robustness, high titers and consistent batch-to-batch performance across all scales.

VIVEbiotech currently produces lentiviral vectors using an adherent process and is developing a suspension process to further expand versatility and meet diverse project needs.

Yes. We work with a broad range of pseudotypes to support diverse therapeutic applications, allowing customers to tailor vector tropism to specific target cells or tissues. Our team is experienced in evaluating and implementing the most suitable pseudotype based on each project’s scientific and regulatory needs.

Yes. At VIVEbiotech, we work with a standard packaging cell line for lentiviral vector production, for which we already cover all associated fees and licenses, allowing our clients to proceed without managing these costs themselves. In addition, we make available our proprietary stable cell lines, which enable lentiviral vector production without the need of transfection and can offer benefits in terms of simplicity, reproducibility, and overall process cost-efficiency.

Yes. VIVEbiotech provides fully integrated end-to-end CDMO services, from early development and process optimization to GMP manufacturing, quality control, regulatory support, and batch release. This seamless approach ensures consistent timelines, reduced project risk and efficient progression toward clinical and commercial milestones.

Yes. We have broad experience in manufacturing lentiviral vectors for CAR-T therapies, offering scalable solutions from early development to commercial supply with high titers and reproducibility.

Yes. We produce GMP‑grade lentiviral vectors specifically designed for in vivo administration. Our manufacturing processes are fully optimized to ensure high purity, safety, and biological potency, meeting the strict quality requirements needed for direct administration into patients.

We have partnered with twelve dedicated clients in this field, from which 2 are already in the clinic, ensuring robust processes and regulatory compliance. VIVEbiotech is recognized as one of the leading lentiviral vector manufacturers for in vivo applications.