VIVEbiotech

VIVEbiotech

Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.

About the plant

Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.

We operate Europe´s largest 3,000 sqm facility exclusively dedicated to lentiviral vector manufacturing. Our plant features seven state-of-the-art cleanrooms with fixed-bed bioreactors ranging in size from 2.4 sqm to 200 sqm. We provide comprehensive services, including process development starting from your Gene of Interest (GOI), analytical development, and automated Fill and Finish for both bags and vials. Our expertise spans early-stage development through to clinical and commercial-scale manufacturing, ensuring a seamless and efficient technology transfer.

We support projects from the earliest stages of development through to commercial scale, having successfully manufactured over 150 batches using our robust plug-and-play manufacturing platform. Currently serving more than 50 international clients across the US, Europe, Asia, and Australia, our facility adheres to both FDA and EMA regulatory standards. Our lentiviral vectors are utilized in the development of gene-modified cell therapies for ex vivo applications, as well as gene therapy products for in vivo treatments.

In addition to our manufacturing expertise, our deep knowledge in virology allows us to produce lentiviral vectors across multiple generations and pseudotypes, both integrative and non-integrative.

With seven state-of-the-art cleanrooms dedicated to lentiviral vector production, we are equipped to handle projects from early-stage development to clinical and commercial-scale manufacturing. We are proud to be the largest CDMO in Europe solely focused on lentiviral vector production.

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• French Service-Public (CIR)
• MHRA (UK GMP)

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Activity

• ATMP (Advanced Therapies), BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification):
• DEA: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets:

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Batch Size / Reactor

• Small, Medium, Large, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L, > 5000 L, 1 - 10 sqm, 10 - 50 sqm, 50 - 100 sqm, 100 - 200 sqm, > 200 sqm

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream

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