VIVEbiotech
Contact information
- APIs and green chemistry
- CRO / CMO / SMO
VIVEbiotech is a leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.
We support projects from the earliest stages of development through to commercial scale, successfully manufacturing lentivirus batches using our robust plug-and-play manufacturing platform, offering the flexibility to meet the diverse needs of our clients.
We serve international clients across the US, Europe, Asia, and Australia, since VIVEbiotech 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 work hand-in-hand with our clients to tailor our services to their specific needs, whether it involves early-stage process development, clinical supply, or commercial manufacturing. This flexibility, combined with our deep virology expertise, allows us to accelerate timelines and ensure smooth technological transfers, providing our partners with a seamless path from research to market.
Our strength lies in our expertise in virology and bioprocessing, which allows us to successfully develop the most innovative projects using our plug-and-play platform to deliver cost-effective lentiviral vectors in accordance with the most stringent regulatory standards.
VIVEBiotech is a global leader in the field of lentiviral vector manufacturing, consistently driving innovation and operational excellence. Our commitment to the highest standards of quality, safety, and efficiency has positioned us as a key partner for advanced therapies, ensuring the delivery of life-changing treatments to patients around the world.
VIVEbiotech offers a wide range of manufacturing-related services on the lentiviral vectors produced, such as:
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Early-phase development adapted to the requirements of each vector:
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Cloning activities: from design to cloning aimed at increasing productivity and conforming to regulatory requirements, among others.
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Various ad-hoc optimization activities: from adaptations in producer cell lines, to adjustments in transfection, to different pseudotyping strategies, etc.
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R&D manufacture in 2D format.
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R&D manufacture in bioreactors.
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Manufacture of engineering batches for preclinical phases.
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GMP batches for clinical and commercial phases.
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Batch release by our own Qualified Person.
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Stability studies: long-term and in-use.
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Regulatory support including:
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Chemistry, Manufacturing and Control (CMC) section of the Investigational Medicinal Product Dossier (IMPD).
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Chemistry, Manufacturing and Control (CMC) section of Investigational New Drug (IND).
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Comprehensive management of outsourced partners (analytical testing and plasmid manufacturing, among others).
Biotech Industrial
| Product / Service | Development phase |
|---|---|
| Bioprocess development and GMP manufacturing of lentiviral vectors | Ready for explotation |
| Product / Service | Development phase |
|---|---|
| New pseudotyping strategies | Ready for explotation |
| Construct optimization | Ready for explotation |
| Development of more cost-effective gene therapy processes | R&D |
| Stable producer cell lines | R&D |