Manufacturing at 35Pharma, and Jenna Ries, right, Project Manager of Manufacturing Operations at 35Pharma35Pharma specializes in bringing novel biologic therapeutics from concept to clinic—rapidly, safely, and strategically. Success depends on the integration of scientific expertise and adaptable infrastructure, all rooted in a robust quality system. That is why 35Pharma partnered with Samsung Biologics, a global contract development and manufacturing organization (CDMO), known for its proven track record, operational excellence, and strong commitment to client success. Together, they tackled the challenges of developing and manufacturing two complex therapeutic candidates—delivering results through tight coordination, shared accountability, and mutual trust.“Samsung Biologics’ expertise and experience lie in its quality-by-design approaches and systematic risk assessments, which allowed us to accelerate our product development while maintaining confidence in both performance and scalability of manufacturing,” said Thomas Loisel, Vice President of Manufacturing at 35Pharma. “It was clear from the outset that Samsung Biologics had a roadmap for drug development, from process development and technology transfer to project management and quality analytics. Having all these groups synchronize together made our timelines fast and efficient.” This collaboration showcases what is possible when the right strategy meets the right partner: accelerated development, rigorous execution, and a shared victory on the road to approval.Overcoming challenges as a team 35Pharma is a clinical-stage biopharmaceutical company, located in Montreal, committed to developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity, and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology, combined with superior protein engineering, to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta superfamily ligands while sparing beneficial homeostatic ligands.On a mission to find more effective and accessible treatments for diseases that impact millions of patients worldwide, 35Pharma partnered with Samsung Biologics to accelerate the development of its recombinant protein candidates, HS135 and HS235. The 35Pharma-Samsung Biologics partnership obtained clinical trial approvals from the U.S. Food and Drug Administration (FDA) and Health Canada— key milestones on a complex development path. Novel biologic development rarely follows a straight line, but both teams were prepared for any unexpected circumstances. Grounded in a strong chemistry, manufacturing, and controls (CMC) strategy, open communication, and agile execution, they navigated every challenge with precision and speed. “Having transparent dialogue and a partner ready to adapt made all the difference in staying on track,” Loisel said. One of the most significant challenges arose early on in 35Pharma’s development of its first product, HS135. “The molecule’s complex glycosylated structures had to be closely monitored throughout cell line development, requiring careful evaluation of both culture performance and product quality to ensure a robust clone was selected for manufacturing,” said Jenna Ries, Project Manager of Manufacturing Operations at 35Pharma. Understanding the inherent risks associated with the molecule’s structure, Samsung Biologics implemented a quality-driven cell line development method, which incorporated targeted glycan evaluation at key stages to accommodate the unique characteristics of a complex biologic. Samsung Biologics leveraged its flexible resources to provide a customized approach to cell line development that matched 35Pharma’s product quality requirements for increased protein sialylation. To achieve this, Samsung Biolo
