As interest in injectable biologics for cancer and other diseases continues to surge, CDMO Simtra BioPharma Solutions is catching the wave stateside with plans for a new commercial manufacturing project in the U.S.
The injectable production specialist has snapped up a 65-acre property with more than 300,000 square feet of usable space to expand its existing fill-finish facility in Bloomington, Indiana, according to a July 25 press release.
Though details are slim, Simtra says it’s “evaluating a project to design and install manufacturing lines at the site,” with the company’s first U.S. commercial-scale capacity for injectable oncology medicines a key focus of the endeavor.
The project has the potential to position Simtra as the "first CDMO to offer commercial-scale drug product manufacturing of antibody-drug conjugates (ADCs) in the United States," according to the company's announcement.
Once up and running, the facility will run isolator-based vial and prefilled syringe lines, the company said. Simtra did not disclose the cost of the property purchase nor the amount it plans to invest in its Indiana expansion project.
The move comes as construction rolls ahead at the Bloomington site under a separate, $250 million expansion Simtra announced last February.
That earlier project revolves around a new 150,000-square-foot building that will ultimately house two high-speed automated isolator filling lines and a new high-speed line with three 30-square-meter (323-square-foot) lyophilizers for freeze drying, Simtra said last year.
Overseas, the CDMO recently completed a new $100 million production building at its second manufacturing site in Halle Westfalen, Germany, and is also building out a $14 million conjugation and purification suite there.
Simtra’s ADC expertise recently won the company a five-year partnership with Merck KGaA’s MilliporeSigma to create a “turnkey offering” for drugmakers in need of ADC production. Under the contract manufacturing accord, MilliporeSigma will tackle bioconjugation steps for client projects at facilities in St. Louis or Madison, Wisconsin, while Simtra oversees drug product formulation and fill-finish.
Apart from Simtra’s MilliporeSigma team-up, June saw several other prominent ADC manufacturing projects make headlines.
At the start of the month, Swiss CDMO Carbogen said it was investing 25.5 million Swiss francs ($31 million) in conjunction with an unnamed Japanese partner to equip two of its three local facilities for commercial production of linkers. Linkers are the chemicals that connect antibodies to drug payloads in ADCs.
Elsewhere, API specialist Veranova said last month that it would invest another $20 million at its campus in Devens, Massachusetts, to build new bioconjugation capacity for ADCs and other bioconjugate drugs.