Simtra BioPharma Solutions, a CDMO specializing in sterile injectables, has formed a five-year strategic alliance with the Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada. 

The partnership will create a turnkey offering for biopharmaceutical companies seeking ADC and bioconjugation, linker/payload manufacturing, drug product formulation development, and fill-finish capabilities.

Manufacturing ADCs combines a monoclonal antibody, a cytotoxic payload, and a linker, each with its own production challenges, into a single, stable, and effective therapeutic. 

This new alliance creates a seamless development and contract manufacturing value chain with the bulk drug substance conjugated by MilliporeSigma directly transferred to Simtra for drug product fill/finish. 

Customers will receive streamlined support with designated project managers at each of the partners’ sites working closely together to ensure smooth transfers and expedited timelines.

Most biopharmaceutical companies seek out multiple manufacturing partners to develop antibodies, high-potency active pharmaceutical ingredients/cytotoxic payloads, and linkers, perform the conjugation and purification step, and complete fill-finish.

“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,” said Franco Negron, CEO of Simtra BioPharma Solutions. “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.”