Arranta says GMP plant on track despite pandemic

Microbiome contractor Arranta Bio says construction of its commercial scale manufacturing plant is on schedule despite the coronavirus pandemic.

The contract development and manufacturing organization (CDMO) announced the mechanical completion of GMP suites at the facility in Watertown, Massachusetts this week.

CEO Mark Bamforth thanked, “Our construction management partner, DC Beane and Associates Construction Company…and the numerous sub-contractors who have supported Arranta and worked through the pandemic in a safe and efficient manner to keep our commercial-ready manufacturing facility build-out on schedule.”

Image: iStock/ChrisChrisW

Previously, Arranta said the 70,000 square-foot plant would have a range of fermenters up to 2,000 L scale that will be able to manufacture LBPs – live biotherapeutic products – for multiple clients. The firm expects the plant to be operational in 2020.

In addition to building the Watertown facility, Arranta is also expanding process development and GMP manufacturing capacity at its early-clinical supply facility Gainesville, Florida.

LBP market

Live biotherapeutic products (LBPs), as the name suggests, are living organisms. Unlike probiotics used to try to improve general health, LBPs are drugs intended to treat or cure disease.

They are regulated as drugs and must go through clinical trials and be manufactured under cGMP conditions.

The market for LBP services is small but growing according to Chr. Hansen, which teamed with Lonza to set up a microbiome-focused CDMO in 2019.

At the time the firms said, “Given the current number of ongoing preclinical to phase III drug trials, the clinical supply industry globally is estimated to reach EUR 150-200 million [$175-235 million] by 2025.”

It also predicted the market could be as much as €1 billion by 2035.

This was echoed by Lonza, which told us at the time that although most LBP developers are smaller biotechs, “We are also starting to see a few larger companies like Ferring or Takeda acquiring and partnering in this domain.”

Other contractors active in the space include Australia’s Luina Bio, which announced plans to increase capacity for clinical and commercial manufacturing last month, also citing market growth.