Single-use bioprocessing systems

Single-use systems replace stainless steel bioreactors, mixing vessels, tubing and filters with pre-sterilised disposable assemblies made of multilayer polymer films, sterilised by gamma irradiation from cobalt-60 sources (a link to the same isotope supply chain that serves radiotherapy). A 2,000-litre single-use bioreactor needs no cleaning or steam-in-place validation, so a plant can change product in days and be built in about half the time of a stainless facility; most cell therapy, viral vector and clinical-scale antibody manufacture, and a growing share of commercial antibody production, now runs this way. The trade-offs are film extractables and leachables (tested under industry protocols), per-batch consumable cost, plastic waste and a practical ceiling of a few thousand litres per bag.

The supply base is concentrated: Sartorius, Cytiva, Thermo Fisher and Merck KGaA make most bags, films and filters, and the film itself often comes from one extruder. During the COVID-19 vaccine build-out in 2020 to 2022 lead times for bags and filters stretched past a year and cancer drug makers competed for the same components, an episode that regulators and industry groups now cite when they argue for dual sourcing and standardised connectors.