90+
clients’ audit
One-Stop Lentivirus Solution
Streamline your LVV development with our one-stop solution covering process development, analytical development, suspension production, GMP manufacturing, and stability testing. Our comprehensive services support regulatory filings and ensure a seamless transition from preclinical to commercial phases.
Process Development
Leverage our expertise in developing stable, scalable, and robust manufacturing processes for both our adherent and suspension systems. Our dedicated PD lab offers upstream and downstream process development, lab-scale viral vector manufacturing for process validation, and process scale-up, reducing development cycles and streamlining operations.
Analytical Development
ProBio provides a wide range of assays tailored to your specific needs, ensuring quality control throughout your LVV production with analytical support for analytical development, qualification, validation and transfer. Our team has extensive experience developing tailored assays for your specific requirements and applications.
Regulatory Support
Navigating regulatory requirements can be complex. Our team simplifies the process with comprehensive support for FDA/EMA IND applications, BLA filings, and other regulatory submissions. Trust us to guide you through every step.
Stability Test
Monitor product integrity with ICH-compliant stability studies. We provide comprehensive analysis examining light, heat, and humidity to determine their impact on active ingredients, ensuring long-term product stability and efficacy.
Tailored Solution from Preclinical to Commercial
Scalable Support Across Every Phase
From early-stage development to commercial supply, our Lentivirus CDMO platforms adapt to your program's evolving needs. We provide flexible production scales, optimized processes, and regulatory-ready documentation to ensure a smooth progression from IND through BLA. Whether you're working with adherent or suspension systems, ProBio is your scalable, phase-appropriate partner.
Cell line for LVV manufacturing
ProBio offers proprietary suspension PowerSTM-293T and authorized adherent PowerATM-293T cell lines for LVV manufacturing. These cell lines provide superior monoclonal dispersion, high viability, and consistent LVV yield, supporting your project from early research to commercialization.
Proprietary Suspension PowerSTM-293T Cell Line
- Flexible business model without royalty fees.
- Superior monoclonal dispersion and high viable rate.
- High & consistent LVV yield with various gene of interest tests
Your Trusted Lentivirus CDMO Partner
ProBio has a track record of lentiviral vector manufacturing excellence with proven platforms that consistently deliver results.
20+
IND Track Records
700+
plasmid and LVV clinical manufacturing batches
2,000 m²
Viral Vector Manufacturing Facility
2-200L
Manufacturing Scale
100+
GMP manufacturing batches
LentiHelperTM Plasmid Products
Packaging of 3rd generation lentiviral vectors employs 3 helper plasmids and 1 transfer plasmid. ProBio provides royalty-free helper plasmid products, for packaging lentiviral vectors with availability from the preclinical to commercial stage.
Key LentiHelperTM Advantages
- DMF Registered: Ready for FDA IND Application
- Phase Appropriate: Available from Pre-clinical to Commercial Stage
- De novo synthesis and manufacture: utilizing fully regulatory compliant platforms.
Accelerated, Integrated Development Timeline
Streamlined Solutions for IND Filing
Our streamlined 6-month pathway from plasmid DNA into GMP-grade lentiviral vectors, ready for clinical use. With in-house plasmid production, process development, analytical services, and GMP manufacturing under one roof, we eliminate handoffs and reduce risk. Dedicated project teams ensure milestone-driven execution.
