LVV One-Stop Solution

ProBio provides GMP-compliant, fully characterized cell banks to support reliable LVV manufacturing from clinical development through commercialization.

• HEK293T MCBs and WCBs for adherent culture
• PowerS™-293T proprietary cell line for suspension culture

Supporting efficient scale-up from early research to clinical and commercial manufacturing. Leveraging both adherent and suspension systems, we help optimize process performance, reduce development timelines, and enable successful GMP readiness.

• Upstream process development
• Downstream process development
• Process validation support
• Process scale-up and optimization

Our comprehensive testing platform supports product quality, CMC requirements, and regulatory submissions while offering customized assay solutions to meet project needs.

• Method development, qualification, validation, and transfer
• Functional titer and potency assays
• HCP, host cell DNA, residual plasmid, benzonase, and SV40 testing
• Sterility, endotoxin, and mycoplasma testing
• Customized analytical solutions

Backed by 200+ successful LVV production batches across preclinical, clinical, and commercial programs. We deliver high-quality vectors supported by comprehensive testing, qualified facilities, and rigorous quality oversight.

• 200+ GMP LVV batches delivered
• Adherent and suspension production platforms
• Quality testing for identity, purity, safety, and potency
• Qualified facilities and robust quality systems
• Clinical-to-commercial manufacturing support

ICH-compliant stability studies to evaluate LVV integrity, potency, and safety throughout product storage and handling. Our testing programs support shelf-life determination, product development, and regulatory submissions.

• Stress testing (temperature, light, freeze-thaw, agitation, humidity)
• Accelerated and long-term stability studies
• Shelf-life and storage condition assessment
• Support for CMC and regulatory filings
• Product integrity, potency, and safety evaluation

ProBio’s LVV IND-enabling services have supported over 35+ IND approvals globally. Our experienced Regulatory Affairs team provides professional support for global IND submissions.