There is no one size fits all approach for determining the best time to evaluate extractables and leachables. A drug safety profile should be clinical-phase appropriate and based on patient risk.
Common inputs include:
user experience and historical data on the single-use systems,
supplier biocompatibility data,
supplier extractables data, and
user-generated in-process leachables data.
It is important to review of all aspects of the manufacturing process in combination with consideration of the formulation chemistry and the materials of construction of the bioprocess equipment it comes into contact with. The extractables profiles for the single-use technologies used in the manufacturing process provide a useful source of information to aid in the evaluation process. The data for GE Healthcare single-use technologies can be accessed through the following website: www.gelifescisences.com/rsf. The specific pathway a company will take blends many other product and process inputs, and is greatly influenced by the company's perception of risk.