Over the last decade, the growing use of single-use technology (SUT) in the biopharmaceutical industry has transformed how drugs are developed and manufactured. Traditional methods using large stainless-steel bioreactors with costly clean-in-place and sterilize-in-place systems have been replaced, in most cases, by more efficient SUT bioreactors. Not only do SUT bioreactors reduce the costs associated with drug manufacturing, but they also offer more flexibility, allowing companies to streamline operations and increase productivity. However, as many benefits as there are to SUT, there is one critical issue drug companies must address when transitioning to plastic equipment, and that is the presence of extractables and leachables (E&L). E&L are defined by the Biophorum Operations Group (BPOG), an industry organization, as follows1
- Extractables – A chemical entity that is extracted from a component of a process system into a solvent under controlled conditions that are usually more aggressive than normal operating conditions.
- Leachables – A leachable is a chemical entity that comes from single-use systems during normal use.
Testing for E&L and mitigating risks to a product—and more importantly, the patient who relies on it—are essential to being a trusted and reliable supplier in the single-use industry.