Expediting the customer journey from discovery all the way through commercial release.
The road less traveled
We simply need your gene of interest (GOI) to provide swift, top-notch cGMP material using our optimized one-stream platform to help reduce cost and expedite the journey to clinical trials.
Our team of experts are with you every step of the way
Research Vector Services
Under the direction of our founder, Dr. Shangzhen Zhou, we produce high quality vectors for use in research & discovery utilizing our legacy platform that deliver unparalleled potency. We consistently produce vectors up to total 10e16 with high titer (e13vg/ml), empty capsid free (>90% full), purity measured by SDS PAGE, and less cellular impurity and endotoxin—delivered from our process that is designed with business continuity in mind for researchers with aspirations to move their studies into the clinic.
Process Development & Toxicology Material Services
Our platform provides a turn-key solution for the entire viral vector manufacturing process, from our proprietary cell line to drug product. Understanding the nuances in vector production, we aim to ensure process robustness and high-quality vectors, while minimizing de-novo process development. This approach allows us to manufacture representative toxicology batches within weeks of contract signing. Our platform, infused with Quality by Design (QbD) principles, and the data generated in your toxicology batch, enable us to proceed to GMP without additional development or engineering runs, saving you valuable resources to allow you to focus on study designs.
GMP Manufacture Services
Speed to clinic paired with right-first-time execution is in our DNA. Our integrated supply chain and standard documentation strategies greatly reduce GMP readiness timelines and ensure unparalleled focus on the nuances of your program. Our One-Stream Service achieves the goal of consistency and comparability by utilizing the same working cell line, similar production platforms, and same in-house analytics to ultimately reduce production timelines.
Centered around viral vector product releases, our analytical services center around biological assays that are essential for viral vector quality control. From assay transfer to assay qualification and validation, our analytical team is ready to assist. Our goal is to make your ideas a reality.
As part of our cGMP service, VintaBio offers CMC support services to support your IND application and pre-BLA submission. Our manufacturing process is understood and thoroughly characterized to help alleviate bottlenecks of gathering additional data to support late-stage clinical programs moving into commercialization. Our CMC team is experienced in supporting the technical support documents needed to supplement pIND or IND applications.
- Vector Screening and Evaluation
- AAV Production (RUO)
- Biological Assays (RUO)
- Platform Bridging
- Pre-clincal Material Production
- Toxicology Material Production
- Scale up & Out
- Process Characterization
- QbD & CMC Support
- Analytical Development and Tox Release
- Formulation Development
- cGMP Cell Line
- AAV Production
- LVV Production
- Process Validation Service
- CMC Support
- cGMP Analytical Testing
- Stability Strategy Support
- Assay Qualification & Validation
- Formulation and Fill/Finish
- Assay Development
- Assay Qualification & Validation
- In Process Sample Testing
- Lot Release Testing
- Stability Support
Our super-producing AAV platform provides the most vector per dollar without compromise. At its core is a proprietary cell line and transfection method that produces 1E17 total vg, making it applicable to even the most dose-demanding indications.