- AAVion®, a fully integrated AAV manufacturing platform designed to accelerate gene therapy development
- A ready-to-use Plasmid Platform intended to meet the increasing demand for plasmid DNA
3PBIOVIAN, a trusted CDMO partner in biopharmaceutical manufacturing proudly announced today the launch of AAVion® Platform, a fully integrated adeno-associated virus (AAV) manufacturing solution, designed to accelerate gene therapy development. AAVion® Platform offers biotech and pharma companies a seamless end-to-end journey from in-house plasmid production to aseptic fill and finish, helping reduce timelines and costs while smoothing the path to clinic.
The AAVion® Platform unifies all essential steps of AAV manufacturing into a cohesive process: from vector design and assembly through in-house plasmid production and cell banking to upstream processing, downstream purification, complete quality control (QC), release analytics, and aseptic Fill & Finish. Built around a proprietary HEK293 cell line, the AAVion® Platform delivers a robust and scalable AAV production process across multiple serotypes. With scalability from small-scale shake flasks to stirred-tank single-use bioreactors, the AAVion® Platform provides continuous support for client programs from laboratory to clinic. The purification process has been designed to obtain high titers and purities with multiple AAV serotypes, without major optimization. Leveraging 3PBIOVIAN’s extensive in-house QC capabilities and deep regulatory experience, AAVion® Platform reduces complexity and supports faster time-to-patient. Aseptic Fill & Finish is performed in-house, ensuring full control, traceability, and compliance through to the final Drug Product. 3PBIOVIAN also offers clinical labeling and direct delivery of AAV Drug Product to clinical sites, accelerating the path to clinic. With this comprehensive platform approach, clients benefit from a clear, consolidated workflow and a trusted partner capable of managing every phase of AAV manufacturing and clinical supply under one roof.
“AAVion® is the result of focused development and cross-functional expertise in gene therapy manufacturing”, says Pirkko Kortteinen, COO of 3PBIOVIAN. “With our high-yield HEK293 cell line and integrated capabilities, we are able to deliver scalable AAV production tailored to our clients’ serotype and clinical needs.”
In addition to complementing the AAV manufacturing, 3PBIOVIAN’s Plasmid DNA (pDNA) Platform is now available as a standalone service. This platform approach, covering research-grade, high-quality (HQ) to GMP-grade plasmids, is designed to meet the increasing demand for plasmid DNA, not only for AAV viral vector production, but also for other advanced therapeutic applications such as mRNA, cell therapy, and vaccines.
“Our Plasmid Platform is a key part of the AAVion® ecosystem, but it also stands on its own”, explains Kortteinen. “We offer research-grade, HQ, and GMP-grade plasmids, produced entirely in-house, ensuring quality, consistency, and shorter lead times for clients across various therapeutic modalities.”
Both platforms are now available to biotech and pharma companies worldwide. Whether clients need full AAV manufacturing support or standalone plasmid supply, 3PBIOVIAN is equipped to be a reliable, forward-looking CDMO partner.
“These launches mark an exciting milestone in 3PBIOVIAN’s growth”, says Elena Erroba, CCO of 3PBIOVIAN. “With the AAVion® and Plasmid Platforms, we are delivering our vision to provide a true end-to-end service model for gene therapy innovators, helping clients navigate complexity, reduce risks, and reach patients faster. Our transparent, agile collaboration model is especially suited for small and mid-sized biotechs looking for a committed partner, not just a provider”.
To learn how AAVion® and our Plasmid Platform can support your gene therapy development and accelerate your product’s time-to-patient, contact us.
