Single-use components and systems (commonly referred to as disposables) have traditionally been utilized in development labs and clinical supply facilities. These pre-packaged components or systems have been sterilized and validated and are disposed of after a single use.
In recent years, disposables have also found their way into processes for pilot and contract manufacturing plants. Today they are available for practically every aspect of biopharmaceutical manufacturing including fermentation, buffer, media, filtration, purification, and separation applications. As volumes reach over 1,000L, the trend today is a marriage of single-use components and reusable stainless steel.
Single-use components and systems make sense for clinical development and contract manufactures to employ, because the production runs are small and varied. However, at this time large-scale commercial production still uses predominately reusable stainless steel, due to the fact that the facility has been validated, and it does not make commercial sense to change the process.
When we look 5-7 years into the future, how will a large-scale bioprocessing plant handle processes upstream and downstream? Will they continue to utilize reusable stainless steel, will they employ all single-use processes, or will we see a combination of disposable and stainless steel?
Please weigh in with your thoughts on how production will be handled in state-of-the-art biotech facilities in 2020.
