The Risk And Reality Of 3D Printed Parts In Single-Use Workflows

Additive manufacturing, or 3D printing as it's more widely known, is increasingly common in biopharmaceutical process development labs. While speed and flexibility make it appealing, developers should be aware of the risks. James Dean Vogel of The BioProcess Institute, Vikash Kumar at Merck, and former industry executive Robert Dream agreed the technology excels for rapid prototyping and non-product-contact parts, but cautioned that accessibility doesn't reduce regulatory burden. Full E&L testing, material traceability, and reproducibility qualification still apply, especially for product-contact parts. They stressed phase-appropriate risk management, ICH Q9/Q12 principles, and documentation discipline, framing every printed component as a potential future regulatory story. The consensus? 3D printing remains primarily a development tool, not yet ready for commercial manufacturing.