Merck KGaA's MilliporeSigma unit more than doubled its gene therapy manufacturing capacity in April as it set its sights on the future. Now, the German drugmaker is making a big down payment on a new manufacturing scale-up, this time for next-generation oncology meds.
MilliporeSigma will spend $65 million on a new commercial building near its Madison, Wisconsin, plant to boost production of high-potency active pharmaceutical ingredients (APIs) used to make antibody-drug conjugates (ADCs), the company said Wednesday.
The 70,000-square-foot expansion will complement existing work at an additional ADC site in St. Louis—the first commercial ADC facility in North America designed to handle highly active materials, the company said.
The expansion will bring on 50 new full-time workers starting next year for MilliporeSigma, which is the life science business of Darmstadt, Germany's Merck KGaA and boasts a workforce some 22,000-strong. Completion of the commercial building is expected to wrap by mid-2022, MilliporeSigma said.
MilliporeSigma aims to position the new building as one of the largest dedicated high-potency API manufacturing facilities and will equip the site with containment areas to turn out next-generation linker and payload materials for ADCs, which have the potential to treat cancer.
Much like cell and gene therapies, ADCs have gained in popularity in recent years as next-gen cancer therapies with extremely strenuous manufacturing requirements.
Only nine ADCs were approved globally as of 2019, but the industry is expected to grow over the next decade and could reach $15 billion by 2030, according to a report by the European Pharmaceutical Review. Much of that work could be outsourced to dedicated contract manufacturers, which already handle 70% of ADC production, MilliporeSigma said.
Early last month, British pharma GlaxoSmithKline snared approval for its own ADC, Blenrep, as a treatment for multiple myeloma patients who have already tried four other treatment options, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
Despite some eye toxicity concerns linked to Blenrep, SVB Leerink analyst Geoffrey Porges called the drug's approval "a significant milestone, and an accomplishment for the drug's developers," in a note to clients at the time. Porges forecasted $377 million in global Blenrep sales in 2021 and $1.93 billion in 2024.
Meanwhile, the ADC upgrade marks MilliporeSigma's second expansion of the year: Merck KGaA and its subsidiary in April made plans to invest $110 million to open a second viral vector facility in Carlsbad, California, slated to "more than double" MilliporeSigma's gene therapy manufacturing capacity, the company said.
The plans for that expansion followed a 2016 production boost at the Carlsbad facility that grew the site by 21,000-square-feet and added 16 modular bulk manufacturing cleanroom suites and two fill/finish suites for gene therapy, viral vaccines and immunotherapy products.
Editor's note: This story has been corrected to state that MilliporeSigma's site in St. Louis was the first commercial ADC facility in North America.