AGC ups cell therapy capacity at Longmont plant

AGC Biologics has added over 30,000 square feet of space to accommodate three cell therapy suites at its Longmont, Colorado site.

The latest expansion sees contract development manufacturing organization (CDMO) AGC add two process suites and one flex suite at its Longmont plant, expanding the firm’s cell therapy capabilities. AGC said the additional capacity means the firm can offer its clients a full life cycle of cell therapy advancement and manufacturing services in one location.

According to the company, the multiproduct suites are segregated and have been designed to have flexible capacity configuration, the latest cell and gene therapy (CGT) equipment, and the ability to offer autologous and allogeneic cell therapy production.

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The site also has fill-finish capabilities, early-stage process development services, commercial production, and quality control and analytics. Moreover, the CDMO said the Longmont site has “ample space” and a further nine cell therapy suites could be added to meet market demand.

“The new cell therapy suites are a tremendous achievement for this site. We have integrated the latest technology to complete our unique cell therapy services and have created ideal environments for developing these life-changing treatments,” said Whitney Sandberg, general manager, AGC Bio Colorado.

“This is the final piece for this campus that accompanies our comprehensive viral vector capabilities and gives developers a true end-to-end manufacturing site in North America to support their product’s every need, at any stage.”

This latest expansion differs from AGC’s decision to double its viral vector capacity at its Longmont facility to advance manufacturing of gene therapies in May 2022.

Longmont history

AGC acquired the Longmont campus from Novartis in August 2021 for an undisclosed fee. The plant itself has had various owners over the years. Before AGC bought the facility, Amgen once used the plant to produce drug substance for its blockbuster biologics Epogen (Epoetin) alfa and Aranesp (darbepoetin alfa).

However, in October 2016, AstraZeneca purchased the plant for an undisclosed fee, with plans to use the site – together with the nearby LakeCentre facility in Boulder, also bought from Amgen, albeit two years prior – to support its biomanufacturing aims.

But, an operational restructure in 2019 saw AstraZeneca offload both Colorado sites in efforts to consolidate its biomanufacturing operations at its Frederick, Maryland site.

The Boulder plant was picked up by AGC  for around $100 million in June 2020, while Novartis bought the Longmont plant to support its then lead candidate Zolgensma (onasemnogene abeparvovec-xioi1), added to its pipeline through the acquisition of AveXis.

In March 2021, Novartis announced plans to shutter the plant before manufacturing had even begun, citing changing gene therapy capacity needs.