Our process offers reliability and consistency by using VintaBio’s proprietary cell line and production platform from the research vectors through clinical vectors, helping turn your concept into a successful program. Coupled with our strong process development and analytical teams, our one-stream process will have you covered from proof-of-concepts through clinical trials in gene therapy development.
We offer vector production at multiple different quality scales:
- Research Use Only (RUO) vector material
- Toxicology Material
- cGMP material
RUO vector material is typically generated at a controlled research lab with a dedicated production team. Although the production process is consistent, it is not controlled, recorded, or reviewed by our quality team.
Toxicology vector material is generated in a controlled lab with a dedicated production team. Materials are consistent with those used in RUO scale, including the plasmids and master cell bank, and execution of the batch is documented to meet standards for GLP manufacturing practices.
Our cGMP material is produced in a dedicated, monitored BSL2 suite. All materials used for cGMP production go through a review and release process and are dedicated to a batch with oversight from our Quality Management System (QMS).
Each request is individual, unique, and special. Please fill out the “Contact Us” form on this page so we can address your questions and tailor fit a manufacturing strategy to suit your needs.
Currently, we are optimizing and building upon our legacy platform that has been successfully used in over 3300 batches of research vector to ensure scalability and higher purity. Leveraging advancements in fixed bed bioreactors, we are scaling our viral production process to meet dosing requirements for any indication. Our platform process consistently delivers viral vector that is high yield, high titer, and >90% full. As such, the performance of our vectors is unparalleled in the industry.
As a result of our high performing platform process, we can deliver GMP vector from sequence in as little as 3 months.
We take pride in the extensive characterization of our platform process and corresponding investment in CMC. This focus helps alleviate the CMC burden for our clients where they can leverage our regulatory support file.
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.