Simtra BioPharma Solutions, MilliporeSigma form alliance for ADC manufacturing

Simtra BioPharma Solutions has inked a five-year strategic alliance with MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, to support the manufacturing of antibody-drug conjugates (ADCs).

The partnership will combine Simtra’s sterile injectable expertise with MilliporeSigma’s capabilities in bioconjugation and payload manufacturing, creating a unified drug development and production workflow.

Under the agreement, ADC drug substance produced by MilliporeSigma will be transferred directly to Simtra for fill-finish, offering clients a turnkey solution across the ADC manufacturing value chain. Designated project managers at both sites will coordinate efforts to streamline transfers and reduce development timelines.

More than 70% of ADCs are currently manufactured by CDMOs, and with over 200 candidates in active clinical trials, demand continues to rise. A Roots Analysis study projects the ADC manufacturing market to grow from $1.79 billion today to $7 billion by 2035. The alliance is positioned to address industry challenges around fragmented manufacturing processes by reducing handoffs and consolidating services.

The companies stated that the collaboration aims to support biopharma clients in accelerating time to market while maintaining high quality standards. The integrated approach is expected to help minimize production delays and enable faster access to therapies for patients.

“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 — ultimately accelerating the delivery of life-changing therapies to patients who need them most,” Simtra CEO Franco Negron said in a statement.