Development of a Standardized Extractables Approach for Single-Use Components: General Considerations and Practical Aspects — A Manufacturer's Perspective

The subject of extractables for single-use bioprocess contact materials has been a subject of heated debate since roughly the summer of 2012, when the first ISPE paper was published issuing a call to action to develop a standardized extractables protocol for the industry (1). As a supplier that pioneered the science of extractables (2‒11) and has published extractables data for our products for over 20 years, Sartorius Stedim Biotech (SSB) took the opportunity to look back, take stock, rationalize, and define a new internal procedure for extractable analysis of single-use components. The existing approach to support biopharmaceutical clients with extractables data and services for implementation of single-use products already evolved over many years at both Sartorius and Stedim before they merged into SSB in 2007.

The decision was made to define a new SSB approach unconstrained by decisions of the past and supported by the best science currently available. We additionally decided that if a strong scientific rationale did not exist for a given decision, then scientific research would be conducted to provide such rationale. We quickly determined that to define our new internal approach, we needed to ask and answer several questions relating to study intent, extraction solutions, conditions of extraction, and analytical methods. Other considerations included the number of lots to be extracted, definition of reporting limits, and third-party components.