Even as the pandemic winds down in the U.S., the push to bring drug manufacturing stateside persists. Privately held contract manufacturer Selkirk Pharma is teeing up a flagship facility in Washington state to do just that.
Selkirk has designs on a $90 million headquarters and production plant in Spokane, Washington. After emerging in 2018 with a focus on injectable drugs, including vaccines and biologics, Selkirk completed the design for its first-ever facility and broke ground in September. It now expects the building to be finished by the second quarter of 2022.
From there, the company will commission manufacturing systems and equipment, John Bertagnolli, vice president of commercial operations at Selkirk, said over email. Operating on that timeline, the company expects to begin tech transfer activities in the third quarter of 2022 and aims to initiate manufacturing runs in the first quarter of 2023.
While the three-year-old company’s launch predates COVID-19, Selkirk is pitching itself as another champion in the quest to “onshore” drug manufacturing capabilities in the U.S.—an effort that reached a fever pitch last year as the pandemic spotlighted weaknesses in the global pharma supply chain.
"Our mission is to establish and provide … more reliable manufacturing for sterile injectables," Bertagnolli said. "We see many companies struggle to find consistent and reliable fill and finish services for their products and we are building a state-of-the-art facility to meet this need."
Selkirk plans to kit out its 145,000-square-foot injectables factory with isolator-based filling systems and electronic batch records. The site will handle both clinical and commercial production. To start, the plant will open with a single line for vial and syringe fill-finish, Bertagnolli said. The initial build-out includes space for two additional filling lines, he added.
The CMO has 25 employees and plans to increase its workforce to 45 by the middle of next year. Selkirk ultimately plans to employ 300 staffers at the plant once it hits full capacity.
Meanwhile, Selkirk already sees expansions on the horizon, and it’s earmarked another $60 million to add production lines and additional manufacturing capabilities at the plant over the next three to five years. The company also has its eye on a second manufacturing facility on an adjacent, eight-acre parcel of land.
Over the past few months, several companies have emerged, government cash in hand, with bids to bolster pharma production capabilities in the U.S. One prominent example came about last May, when the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority rolled out a $354 million contract with hitherto-obscure Phlow Corporation to build a generic medicine and active pharmaceutical ingredient plant in Virginia, which would be used to supply COVID-19 treatments.
Phlow teamed up with generics maker CivicaRx as part of the deal, and, in late January, Civica unveiled plans for a $134.5 million, 120,000-square-foot sterile injectables manufacturing facility in Virginia. The focus there will be on drugs for COVID-19 as well as meds used in emergency rooms, intensive care units and surgeries.
Tennessee-based CDMO August Bioservices also jumped on the onshoring wave last year, unveiling a $64.7 million investment for a 60,000-square-foot, commercial-stage plant in Nashville. The expansion is set to add 180 new jobs in Nashville over the next five years, the company said.