Equipment Equivalency in CMO and CDMO Transfers

During a routine batch production at a CMO specializing in sterile injectable products, operators observed several anomalies indicative of potential equipment equivalency issues:Click to read the full article.

Equipment Equivalency and Operator Training Requirements

Detecting equipment equivalency issues begins with recognizing the signs and symptoms that may indicate a problem with scale-up or technology transfer. Here are common symptoms observed during manufacturing or laboratory…

How to Compare Cleanability of Similar Equipment Designs

Before embarking on a cleanability assessment, recognizing the symptoms of potential cleaning issues is vital. Symptoms can manifest in various ways, and understanding these signals can facilitate timely action.Click to…

How to Manage Equipment Qualification Gaps Before PPQ

During a routine production run for a monoclonal antibody drug substance, operators noticed an increased incidence of deviations in the product specifications related to protein concentration and purity. Initial investigation…