Simtra BioPharma Solutions, a leading contract development and manufacturing organization (CDMO) specializing in sterile injectables, has announced a $14 million investment to expand its clinical-scale conjugation and purification capabilities for antibody-drug conjugates (ADCs). The expansion, set to be operational by late 2025, represents a strategic move to build comprehensive end-to-end service offerings that accelerate time to market for pharmaceutical customers.
New Clinical Suite Capabilities
The new clinical suite at Simtra's Halle/Westfalen, Germany site will support ADC development by offering three key capabilities: conjugation mixing, single-use tangential flow filtration, and diafiltration and buffer exchange. The Halle/Westfalen site currently offers clinical and commercial manufacturing services with expertise in oncology and ADCs, operating under SafeBridge classification and equipped to handle Category 4 drugs.
Strategic Positioning in Growing ADC Market
Franco Negron, CEO of Simtra, emphasized the strategic importance of this investment, stating, "This investment will further strengthen Simtra's leadership in ADC manufacturing, a growing sector, by extending our capabilities in support of our customers and partners in the value chain."
Lidia Serina, Head of Development Services at Simtra, highlighted the comprehensive nature of the service offering: "We are offering customers a true end-to-end solution, from early development to commercial production. This allows for more flexibility, reduces risk, and shortens timelines, ultimately saving our customers time and money."
Comprehensive Service Portfolio
The expansion is part of Simtra's strategy to position itself as a strategic partner offering a full spectrum of services. These services span from early development—including formulation, material compatibility, container selection, lyophilization optimization, and analytical development—to clinical and commercial fill/finish operations.
Company Background and Expertise
Simtra BioPharma Solutions operates as an independently owned CDMO with more than 65 years of sterile injectable manufacturing expertise. The company offers world-class cGMP sterile fill and finish services, technical expertise, and quality service with a collaborative approach to support customers' strategic objectives. Biotech and pharmaceutical companies partner with Simtra when they need to take their molecules to market, whether launching innovations globally, improving formulations, or proactively mitigating risks to grow their business.
