2000m2
Advanced AAV Manufacturing Facility
AAV CDMO End-to-End Support
ProBio delivers end-to-end AAV CDMO services—from cell banking to regulatory support—all to streamline your gene therapy development.
Cell Banking
Secure and characterize your production cells with our comprehensive cell banking services. We offer MCB/WCB construction, cell bank characterization, and stability testing to ensure consistency from the start.
Process and Analytical Development
Optimize your AAV production with upstream, downstream, and formulation process development. We also provide method development and qualification for analytical testing, ensuring reliable data.
Phase Appropriate Manufacturing
ProBio supports demo, verification, and engineering runs at scalable levels, all performed in GMP-compliant cleanrooms with full QC and release testing to meet your program’s needs.
Robust Quality Control
From packaging tests and QC release to comprehensive stability studies—including accelerated and long-term testing—we ensure the highest standards of safety, potency, and consistency for your product.
Stability and Regulatory Support
We provide expert preparation of reports and documents to facilitate regulatory filings, helping to ensure your AAV program meets all compliance requirements efficiently.
Global AAV Manufacturing Facilities
Resilient Supply Chain Solution
Our strategically located AAV CDMO sites in the United States and China ensure a resilient, agile supply chain that meets the needs of any market. With in-house plasmid production and end-to-end capabilities, we streamline timelines and reduce complexity for our partners.
- Stable Supply Chain with Local Operations and Sourcing
- State-of-the-Art Facility & Equipment
- Fast Turnaround Time with No Waiting Time
AAV Suspension Cell Line PowerSTM-293
ProBio’s proprietary PowerSTM-293 cell line enables high-yield, scalable AAV production across multiple serotypes. Designed for GMP compliance, it supports a smooth transition from research to commercialization.
Optimized for High Performance
- Stable AAV packaging across serotypes like AAV2/5/8/9
- Scalable from 3L to 200L f with 30–50% higher crude titer than commercial cell lines
- Achieve yields of up to 1E+12 vg/mL with less than 5% empty capsids.
Your Trusted AAV CDMO
ProBio is a trusted partner with a strong regulatory track record, supporting IND, BLA, and global submissions. We provide high-quality documentation that meets stringent regulatory standards—ensuring a smooth regulatory pathways.
30-50%
Increased titer with our proprietary cell line.
3-200L
Scalable manufacturing volume in our GMP facility
Global Compliance
FDA, EMA, NMPA-aligned documentation and processes
6 Months
From GOI sequence to IND filing under ProBio’s CMC model
4-6 weeks
Fast GMP manufacturing turnaround time for clinical batches
AAssistVTM Triple Transient Transfection
AAssistV™-pHelper and AAssistV™-pRC are engineered to deliver efficient, high-yield AAV vector production from preclinical to early clinical phases. Through the triple transient transfection system and in tandem with our proprietary PowerSTM-293 cell line, optimize your AAV program.
Advanced Plasmid System to Support AAV Production
- Supports multiple AAV serotypes like AAV2, AAV5, and engineered variants
- Sequence-traceable plasmids meet quality standards for clinical use
- Enables tissue- and organ-targeted vector development with flexible serotype options
