Manual Assembly Strategies For Early‑Phase Combination Product Supply

By Justin Lacombe, Ph.D., Chief Scientific Officer, Experic

Manual assembly is a critical capability in early‑phase combination product programs, where flexibility, speed, and control matter more than scale. Before automation is feasible, clinical supply teams must rely on well‑designed manual processes to support rapid iteration, maintain quality, and manage risk across complex drug‑device workflows.

This content explores how strong process design, early cross‑functional collaboration, and disciplined quality controls help teams deliver consistent, trial‑ready materials. Key considerations include process qualification, in‑process checks, reconciliation for traceability, and practical approaches to reducing human error. The discussion also addresses risk management under ISO 14971 and how to determine when and where to segment assembly steps to support clinical timelines.

Readers will gain actionable guidance for strengthening operational control in early development and evaluating partners who can support clinical supply needs while laying the groundwork for future scale.