It is planning to invest US$150M into the US virotherapy production site. The US location will evidently bring proximity to the US clients and will allow a seamless service from R&D and early stage clinical supply to late stage and commercial supply, the company told BioPharma-Reporter.
The global contract development and manufacturing organization (CDMO) expects the site to be operational by the second half of 2021.
In May 2019, Vibalogics was acquired by Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector; that deal is allowing the CDMO to further its growth strategy and fast-track its plans to extend its footprint in the US.
The CDMO said the expansion is informed by the high demand for biomanufacturing services and development capacity in viral vector vaccines and oncolytic viruses.
"The facility is designed to manufacture commercial volumes of viral vectors, such as oncolytic viruses, and can also produce viral vector vaccines. We will implement a 2 x 2,000 L single-use bioreactor train during the first phase, which enables us to provide millions of vaccine doses of drug substance. As long as the vaccine is constructed as a viral vector, we can support COVID-19 vaccine needs as well as RSV, Dengue, HIV, and others," the company said.
Vibalogics Germany started with oncolytic viruses around 2006 and expanded the technology towards vaccines.
Commenting on the US strategy, Vibalogics’ CEO, Tom Hochuli, said the Boxborough located facility will meet the CDMO’s current and future needs, giving it the ability to further expand to meet growing customer demand.
“The site will provide a complete suite of virotherapy services to support drug developers and their most revolutionary products. The addition of a late stage clinical and commercial facility means we can easily tech transfer our customers’ products from our early phase manufacturing facility in Germany to the US, resulting in a complete end-to-end service from pre-clinical to commercial supply.
“Boston is the largest global hub for cell and gene therapy R&D, so there is also a great pool of local talent and expertise to draw from to strengthen the Vibalogics team. The facility is expected to create 100 jobs initially, reaching 250 employees in the next four years.”
If a customer commits early to partner with Vibalogics, the company said space and particularly specific production process needs will be considered during the implementation phase. "Vibalogics will also operate an aseptic fill & finish line in Boxborough, in addition to the one already used in Germany. There is also significant expansion space in the facility to allow us to implement a large scale fill & finish line to serve customers in the vaccine arena."
Vibalogics was recently selected by Janssen Pharmaceutical Companies, a Johnson & Johnson company, as one of its manufacturing partners for its investigational COVID-19 vaccine candidate.
This article was updated on November 18 to reflect the comments on the US site from Vibalogics.