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

The trend toward 3D printing in process development is driven by early-stage benefit: engineers can create custom equipment for scale-up and scale-down initiatives and mitigation of process integration challenges. When sourcing unique or bespoke single-use parts is the bottleneck, 3D printing offers a rapid way to keep development moving. However, it comes with inherent risks.

3D printing puts validation on the shoulders of the sponsor company. Issues like extractables and leachables, integrity, and regulatory scrutiny warrant serious consideration for anyone working toward GMP compliance. Building processes using components that may not exist, now or ever, outside your process lab could upend a pipeline before Phase 2.

Bioprocess Online Live’s expert panel, including James Dean Vogel of The BioProcess Institute, Vikash Kumar at Merck, and Robert Dream, an independent consultant and former biopharmaceutical executive, will explore where and why 3D printing is being incorporated into process development workflows. They’ll also dig into some of the show-stopping hazards of “DIYing” your way to GMP.