Simtra BioPharma Solutions, a leading contract development and manufacturing organization (CDMO) specializing in sterile injectables, has announced 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 creates a comprehensive turnkey offering for biopharmaceutical companies developing antibody-drug conjugates (ADCs) and bioconjugation therapies.
Addressing ADC Manufacturing Complexity
Manufacturing ADCs presents significant challenges as it involves combining three distinct components: a monoclonal antibody, a cytotoxic payload, and a linker, each with its own production complexities, into a single, stable, and effective therapeutic. The new alliance creates a seamless development and contract manufacturing value chain with bulk drug substance conjugated by MilliporeSigma directly transferred to Simtra for drug product fill-finish operations.
"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—ultimately accelerating the delivery of life-changing therapies to patients who need them most."
Market Growth and Industry Demand
The ADC pipeline is experiencing robust growth with an increasing number of biopharmaceutical companies developing assets in this therapeutic area. Currently, more than 70% of ADC drugs are manufactured by CDMOs. According to a Roots Analysis study cited in the announcement, the ADC manufacturing market is valued at $1.79 billion today but is projected to reach $7 billion by 2035, representing a compound annual growth rate of 13%.
The early success of ADCs, particularly treatments for HER2-positive breast cancer, has demonstrated the significant potential of ADCs as cancer treatment options. However, most biopharmaceutical companies currently must engage multiple manufacturing partners to develop antibodies, high-potency active pharmaceutical ingredients/cytotoxic payloads, and linkers, perform conjugation and purification steps, and complete fill-finish operations.
Streamlined Operations and Patient Impact
The strategic alliance addresses current industry challenges by providing customers with streamlined support through designated project managers at each partner's sites, working collaboratively to ensure smooth transfers and expedited timelines. With over 200 new ADCs currently in active clinical trials, the partnership aims to accelerate the manufacturing process and reduce risks associated with knowledge or time loss during handoffs.
"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," said Benjamin Hein, Head of Life Science Services, Life Science business of Merck KGaA, Darmstadt, Germany. "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."
Company Backgrounds
Simtra BioPharma Solutions operates as an independently owned CDMO with more than 65 years of sterile injectable manufacturing expertise, offering cGMP sterile fill and finish capabilities, technical expertise, and quality service. The Life Science business of Merck KGaA, Darmstadt, Germany employs more than 26,000 people across more than 55 manufacturing and testing sites worldwide, maintaining a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing, and testing services.
