Pharma Fundamentals: Hold Times in Biopharmaceuticals, an Introduction
This episode of Pharma Fundamentals provides an introduction to hold times in biopharmaceutical manufacturing and how they differ from hold times in small-molecule drug manufacturing.
In this Pharma Fundamentals episode, Robert Dream, managing director of HDR Company and a PharmTech Editorial Advisory Board member, explains hold times in biopharmaceutical manufacturing. A hold time is the maximum validated period an intermediate or product can sit between processing steps without harming quality, safety, purity, potency, or stability. Pauses occur for reasons like equipment availability, quality control testing, scheduling, cleaning, or transport, and materials must remain under controlled conditions (refrigeration, freezing, controlled room temperature, nitrogen blanketing, light protection) throughout.