The Road To Agile Pharmaceutical Manufacturing

As the pharmaceutical industry shifts toward personalized therapies and faster, more flexible production, traditional batch-based manufacturing is no longer sufficient. One specialty pharmaceutical company partnered with Battelle to break new ground: creating a system to 3D print custom medications directly into blister packs. They didn’t need an off-the-shelf solution—they needed a development partner to transform a bold concept into a compliant, GMP-ready production system.

This project illustrates the growing push for agile manufacturing in pharma. Agile production offers benefits like faster changeovers, small-batch flexibility, localized output, and responsive lines. Yet transitioning from legacy infrastructure to agile systems requires rethinking equipment, operations, and mindset. Retiring fixed lines, implementing modular tools, and validating new processes under GMP guidelines present technical and organizational challenges. Regulatory uncertainty around novel methods like additive manufacturing further complicates adoption.

Battelle’s interdisciplinary team—including engineers, process experts, and regulatory specialists—collaborated with the client to define and validate every step. From lab-scale prototyping to designing an enclosed production environment with real-time quality control, Battelle ensured the platform was precise, scalable, and regulatory-compliant.

More broadly, Battelle helps pharma clients overcome common roadblocks to agile manufacturing: outdated facilities, costly system overhauls, integration barriers, and evolving compliance requirements. With a system-level approach and proven execution capability, Battelle transforms innovative ideas into viable manufacturing solutions.

Agile manufacturing is not a plug-and-play fix—but with the right partner, companies can successfully navigate the path from vision to operational reality. Battelle’s support shows how emerging technologies like in-package additive manufacturing can redefine how drugs are made and delivered.