Extractables and Leachables Evaluation of Single Use Systems for Biopharmaceuticals
New Trends and Critical Considerations
Analytik
Abstract
In biopharmaceutical production, end user needs sustainable Single Use Systems (SUS) products ready for use and expects the supplier to give the required supporting information when systems or operating procedures are changed. Furthermore, the end user also needs valid data for the pre-qualification of materials prior to his choice. He also requires confirmation of the security of the supply chain as well as the compatibility of the SUS with the manufacturing process and that impurities do not leach from the SUS into the finished drug product during the manufacturing process. Hence, the end user has to carry out a full supply chain control for SUS that is difficult to achieve. He needs to identify low-risk suppliers or correct the actions of higher-risk ones to ensure that standards are maintained. Factors that need to be considered in process safety evaluation include the physical and chemical compatibility of materials with the biomanufacturing process as well as the toxicity profiles of SUS materials.
Chemical impurities that migrate into solvents under exaggerated process conditions of pH, temperature and process time are termed „extractables“, whereas „leachables“ are chemical impurities that migrate into the final drug product. It is possible that leachables may come from the process equipment in use. Such an occurrence may contaminate the final drug product. The advantages of SUS need to be assessed against the risks of change. This requires a standard extraction protocol that renders chemical profiles generated from materials of the same functionality but delivered from different vendors comparable.
Abstract
In biopharmaceutical production, end user needs sustainable Single Use Systems (SUS) products ready for use and expects the supplier to give the required supporting information when systems or operating procedures are changed. Furthermore, the end user also needs valid data for the pre-qualification of materials prior to his choice. He also requires confirmation of the security of the supply chain as well as the compatibility of the SUS with the manufacturing process and that impurities do not leach from the SUS into the finished drug product during the manufacturing process. Hence, the end user has to carry
