The Road to Agile Pharmaceutical Manufacturing

When a specialty pharmaceutical company came to Battelle with a bold idea for small-batch, precision drug production, they weren’t looking for an off-the-shelf solution. They had a concept: use in-package additive manufacturing to produce customized medications directly in blister packs. What they needed was a partner to turn that idea into a fully functional, compliant production system. 

Their journey reflects a broader shift underway across the pharmaceutical industry. As demand grows for personalized therapies, faster development timelines and more resilient supply chains, manufacturers are under pressure to rethink how drugs are made and embrace a more agile approach to production. 

Going Agile: Making the Shift in Pharmaceutical Production 

Agile manufacturing holds clear promise for pharmaceutical manufacturers: faster changeovers, smaller and more customized batches, localized production and smarter, more responsive manufacturing lines. But turning that promise into practice isn’t a plug-and-play process. 

Most pharmaceutical manufacturing facilities are built around traditional batch production, designed for long runs of a single product using fixed equipment and highly regimented workflows. Retooling these facilities to support agile manufacturing methods (such as additive manufacturing, continuous processing, and modular or single-use technologies) often means significant infrastructure changes and complex system integration. Manufacturers may need to: 

The shift also requires a cultural and operational mindset change, from planning around static, large-scale production to embracing adaptability, iteration and real-time responsiveness. For many pharmaceutical companies, these challenges are daunting. That’s where the right development partner makes all the difference. 

Turning Vision into Reality: Additive Manufacturing  

For our specialty pharmaceutical client, the shift to additive manufacturing meant developing a completely new production process, integrating unfamiliar technologies and ensuring every step could meet strict pharmaceutical safety and quality standards. The client came to Battelle with an early-stage concept: use in-package 3D printing to manufacture customized tablets directly into blister packaging. Our job was to turn that concept into a robust, compliant production system. Battelle’s interdisciplinary team of engineers, process experts and regulatory specialists worked side-by-side with the client to: 

By guiding the project from concept through pilot-scale development, Battelle helped the client overcome technical, operational and regulatory hurdles—delivering a flexible, GMP-ready platform capable of producing customized medications safely, efficiently and at scale. 

Overcoming Roadblocks for Agile Manufacturing 

Making the leap to agile manufacturing isn’t just a technical challenge—it’s an organizational one. While the benefits are clear, the road is often steep, especially for pharmaceutical companies built on decades of legacy infrastructure and processes. As a result, many companies struggle to get past the proof-of-concept stage. Some of the most common barriers include: 

This is where Battelle makes a critical difference. We work with our pharmaceutical clients to turn agile manufacturing from concept into capability. Whether we’re helping define unit operations, identify enabling technologies or design a compliant production platform, we approach every challenge with a system-level perspective and a clear path to implementation. Our teams bring together engineers, process scientists, software developers and regulatory experts to ensure every decision supports both innovation and operational excellence.  

Agile manufacturing is within reach. And with the right partner, the road to get there becomes a lot clearer.