How Biologic Developers are Using Optimized Platforms and Operations to Reach First-in-Human Trials

Sponsored by Catalent

As biologics pipelines expand, developers face increasing pressure to reach first-in-human (FIH) milestones quickly while managing growing molecular complexity, tight timelines, and evolving regulatory expectations. In this discussion, Emily Schirmer, general manager at Catalent Pharma Solutions’ Madison, Wisconsin site, shares insights on how early strategic decisions in chemistry, manufacturing, and controls (CMC) can influence clinical success.

Schirmer emphasizes that process development and manufacturing considerations are often introduced too late, placing them on the critical path. Engaging early with a CDMO partner with appropriate scale, capacity, and scientific expertise can help streamline development, minimize tech transfers, and support continuity from early-phase through commercial manufacturing. She also highlights the importance of evaluating the full supply chain upfront—drug substance, drug product, fill-finish, packaging, and distribution—and how those capabilities are coordinated across a CDMO's network of sites.

Speed to clinic remains a central priority, particularly for emerging biopharma companies, where rapid progression to proof-of-concept can impact funding and competitive positioning. However, this urgency must be balanced with reliability. Schirmer underscores the value of strong, transparent partnerships between sponsors and CDMOs, built on shared goals, accountability, and collaborative problem-solving.

As molecules progress through development, change is inevitable. Whether driven by process optimization, evolving quality requirements, or adoption of new technologies, these changes must be carefully managed using data-driven and risk-based approaches to support regulatory alignment and reduce the risk of timeline impact.

Schirmer also highlights the advantages of Catalent's Madison, Wisconsin site, where drug substance process development, engineering, GMP manufacturing, and quality teams are co-located—enabling faster decision-making and closer sponsor collaboration for the drug substance portion of the program.

Finally, she points to innovation in cell line development as an important enabler of both speed and efficiency. Advances in expression systems and the integration of technologies such as gene editing are supporting increasingly complex biologics while helping to reduce cost of goods and improve timelines.