Merck KGaA's MilliporeSigma teams with Simtra in ADC manufacturing partnership

While the race is on to develop antibody-drug conjugate (ADC) cancer treatments, so too is the competition to manufacture them.

Hoping to gain an edge in the rapidly growing market are MilliporeSigma and Simtra BioPharma Solutions, who have forged a five-year partnership, creating a “turnkey offering” for drugmakers seeking ADC manufacturing, the companies explained in a release.

Producing ADCs is a complicated process. According to a Millipore spokesperson, the company will handle bioconjugation at its ADC production facility in St. Louis. Bioconjugation is the attaching of a monoclonal antibody to a payload using a linker. 

If a client needs it, Millipore can produce the highly potent payload at its facility in Madison, Wisconsin. Millipore does not handle the production of the monoclonal antibody.

Meanwhile, Simtra will take care of the drug product formulation and the fill-finish. Both companies will handle the analytical work involved in producing the ADC.  

“By bringing together two experts in the ADC value chain, biopharmaceutical companies should benefit from shorter timelines and less complexity, allowing them to focus their efforts on drug discovery,” Franco Negron, CEO of Simtra, said in a release. “Harmonizing our processes with designated program management from start to finish will give customers greater confidence that their product will be delivered on time and to the highest quality standards.”

Both contract manufacturers have recently enhanced their ability to produce ADCs. In October of last year, Millipore—which operates as the CDMO arm of Germany’s Merck KGaA in the U.S. and Canada—unveiled a $76 million investment in its plant in St. Louis, which will add 170 jobs.

For years, Millipore has prioritized ADC production. The company lays claim to being the first commercially approved ADC contract manufacturer in North America with its site in St. Louis. Five years ago, at its complex in Madison, Millipore spent $65 million to build its ADC active pharmaceutical ingredient (API) plant.

As for Simtra, the New Jersey-based company revealed a $14 million investment in October of last year to expand its conjugation and purification capabilities. The investment is part of Simtra’s strategy to be able to produce ADCs end-to-end, the company explained.

Simtra was established as a private company in 2023 when Warburg Pincus and Advent International paid Baxter International $4.25 billion for its biopharma solutions business, which represented 4% of the revenue of the medtech giant.

In their release, Millipore and Simtra said that more than 70% of ADCs are manufactured by CDMOs. The ADC manufacturing market is expected to increase from $1.8 billion today to $7 billion by 2025, with a compound annual growth rate of 13%, according to Roots Analysis.