In the modern era of drug development, this industry has grappled with categorizing and naming the evolving roles of outsourced development and manufacturing partners. Traditional labels like CRO, CMO, and CDMO originated to define distinct service offerings, preclinical and clinical safety research, contract manufacturing, and a hybrid of both. However, as advanced therapy development has matured, these terms have become less easily defined as the breadth of services required expands and we’ve increasingly understood the necessity of overlapping capabilities to accelerate drug development.
Visionary executives, marketers, and business development ranks have experimented with blended terminology to better reflect these expanded services. Some are trying out Contract Research, Development, and Manufacturing Organization (CRDMO) to highlight the growing ambition to integrate research and CMC. Others have leaned into Product Development and Manufacturing Organization (PDMO) to emphasize a more holistic, end-to-end approach. These terms don’t have significant traction, but their appearance underscores an increasing frustration with the limitations of one-size-fits-all solutions associated with traditionally siloed preclinical CROs and CDMOs.
At AmplifyBio, we agree that traditional labels fall short of the value proposition that is desperately needed to commercialize cell and gene therapies. That’s why we focus less on what we’re called and more on what we deliver: a fully integrated drug development experience where characterization, R&D, preclinical safety, and CMC are seamlessly connected. Our clients aren’t just looking for a manufacturer or a single in vivo safety study. They need a development and manufacturing partner who keeps commercialization in mind throughout the journey. The fundamentals of AmplifyBio’s promise are:
Rather than agonize over terminology, we embrace our role as an end-to-end partner, ensuring that every product is rigorously characterized and every development phase is aligned for success. Ultimately, whatever clients choose to call us, our mission remains the same: to bridge the gap between early discovery and scalable, high-quality manufacturing because The Product is the Product,TM and nothing is more important than delivering it safely to patients.
AmplifyBio CDMO Services
AmplifyBio QC and Analytics for Manufacturing
AmplifyBio Preclinical CRO
AmplifyBio Discovery Services
