This month, Contract Pharma explores the latest trends in biomanufacturing and the rise of cell and gene therapy (CGT). We spotlight the critical role that contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) play in keeping this innovation on track. From upstream development to late-stage commercialization, outsourcing partners are now a lifeline for biopharma companies navigating high science, regulatory hurdles, and unpredictable market shifts.

Our feature on CGT outsourcing trends captures this reality head-on. As CGT programs accelerate toward commercial readiness, developers are turning to partners with deep technical skill and regulatory fluency. At the same time, CDMOs are consolidating and evolving to meet demand—building end-to-end capabilities that can handle everything from viral vector production to late-phase clinical manufacturing.

In “Late-Stage Cell Therapy: Key Challenges and the CDMO Advantage,” we explore how the unique demands of late-stage cell therapies are redefining what it means to be CDMO-ready. While autologous and allogeneic therapies promise breakthrough treatment pathways, they also introduce distinct manufacturing, facility design, and cold-chain challenges that not every partner is equipped to handle.

Our analysis of single-use technology (SUT) trends reveals how biomanufacturing facilities are shedding stainless steel in favor of speed, sustainability, and modular flexibility. With bioproduction shifting toward smaller, multiproduct facilities, SUT isn’t just a preference—it’s a necessity. From water and energy savings to cost and space efficiency, single-use systems are enabling developers to meet demand faster and smarter.

Elsewhere in the issue, Bend Bioscience CEO Owen Murray shares his vision for the “next-gen CDMO”—one that combines high science with high service. His insights speak to a broader shift in outsourcing culture: the best partners are no longer just vendors. They’re scientific collaborators and strategic problem-solvers, embedded in the development journey from ideation to commercial launch.

This evolution is mirrored on the CRO front as well. Our overview of industry trends shows how trial complexity is rising—driven by data intensity, AI integration, geopolitical uncertainty, and regulatory fragmentation. Sponsors are responding by moving toward flexible CRO models, blending functional and full-service approaches to adapt trial execution in real time.

From navigating rare disease recruitment to managing long-term follow-up for gene-edited therapies, the stakes are higher than ever. It’s no surprise that emerging biopharmas—many with just one or two lead assets—are leaning heavily on CROs and CDMOs not only to fill gaps, but to actively de-risk their path to market.

Ultimately, the common thread across this issue is agility. Whether it’s scaling a new therapy, responding to supply chain friction, or adjusting trial design midstream, success in this era of biotech requires nimble, science-driven partners. The outsourced model has matured into a backbone of modern drug development, and its strategic value is only increasing.

Tim Wright, Editor

twright@rodmanmedia.com