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Simtra BioPharma Solutions, a CDMO, formed a five-year strategic alliance with the life science business of Germany-based Merck KGaA, which operates as MilliporeSigma in the U.S. and Canada. The partnership was designed to create a turnkey offering for biopharmaceutical companies seeking antibody drug conjugate (ADC) and bioconjugation, linker/payload manufacturing, drug product formulation development and fill-finish capabilities.
According to 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—ultimately accelerating the delivery of life-changing therapies to patients who need them most.”
Complex manufacturing process
Manufacturing ADCs is complex as it involves combining three different components: 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, added Negron, noting that customers will receive streamlined support with designated project managers at each of the partners’ sites working closely together to ensure smooth transfers and expedite timelines.
The ADC pipeline is experiencing strong growth with an increasing number of biopharma companies developing assets in this space, and currently more than 70% of these drugs are manufactured by CDMOs, explained said Benjamin Hein, head of life science services, life science business of Merck KGaA.
A Roots Analysis study showed the market for ADC manufacturing is $1.79 billion today, but is expected to grow to $7 billion by 2035, or a compound annual growth rate of 13%. Early success of ADCs, such as treatments for HER2-positive breast cancer, have helped demonstrate the significant potential of ADCs as a cancer treatment option. However, most biopharmaceutical companies today must seek out multiple manufacturing partners to develop antibodies, high-potency active pharmaceutical ingredient/cytotoxic payloads, and linkers, perform the conjugation and purification step and complete fill-finish, pointed out Hein.
“Patients can’t wait. With over 200 new ADCs in active clinical trials, it is critical that we work to speed up the manufacturing process, reduce the risk of knowledge or time-loss during handoffs, and enable our clients to advance their programs,” he continued. “Connecting the bioconjugation and fill-finish steps will be a value-add for our clients, ultimately meeting their ambitious timelines and allowing the broadest number of patients to benefit in the fastest and safest possible way.”
