Bio-Techne will build a 50,000 square-foot plant in Minnesota with an initial capacity of $140 million of E. coli-derived recombinant proteins to support cell and gene therapy developers.

After months of talk, life sciences services and consumables firm Bio-Techne has laid concrete plans to build a facility in St Paul, Minnesota to produce GMP reagent proteins for use in cell and gene therapy applications.

“The facility is expected to go through qualifications in approximately one year, with commercial sales expected in our fiscal 3Q21 (first calendar quarter of 2021),” Bio-Techne spokesperson David Clair told Bioprocess Insider.

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“The facility is designed for large scale protein production under GMP conditions. Any process that would require larger quantities of these types of products would benefit from the output from this facility.”

The $40-50 million (€36-45 million) investment will have an initial capacity of around $140 million in GMP proteins, with the ability to expand to approximately $200M as needed.

“GMP proteins are a critical component of the cell and gene therapy workflow, with GMP proteins acting as the ‘food’ necessary to grow the edited cells prior to putting them back in the patient,” Clair added.

And E.coli or bacterial expression of a protein supports Bio-Techne’s aim to make these proteins in an animal-free environment to reduce the risks of adventitious agents (viruses, etc.) contaminating the final product, Clair added.

Expansions and cell therapies

The announcement came at the same time as Bio-Techne’s Q1 2020 financial results.

Speaking on the supporting call, CEO Charles Kummeth said the new facility is a refit of an old site, which has saved a year or more on a greenfield site

“It was an absolute awesome facility for the way it’s laid out for us. So we really just got to fill it with our stuff which is most of the money as you know,” he told investors. “The stuff is expensive to put in there with the large reactors, all the sterile piping, the in and out rooms, the clean rooms, it looks like a small pharma factory, right. It’s a bio processing factory is what it is.”

He added the site has room for further expansion in the future which “could be really big for us and we don’t have to worry about buying another one for quite some time.”

He also explained Bio-Techne will be supplying GMP proteins for cell and gene therapies that use both a viral and non-viral methodology, going forward.

For the quarter, the firm reported sales in its Protein Sciences segment of $141 million, up 12% year-on-year.