We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless-steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer. We accounted for facility size, water consumption, energy use, and carbon emissions from all steps, including even steel manufacture, transporting plastics to and from the facility, plastic incineration, and employees driving to work.
Introduction to Sustainability
Traditional facilities with fixed-in-place stainless-steel fermenters, tanks, and associated piping and valves are still the prevalent manufacturing methodology to produce biological drug therapies. Many vendors, consultants, and drug companies are endeavoring to replace such traditional facilities with single-use systems to improve flexibility, cost, and also environmental footprint. It may seem paradoxical to claim that a single-use system can have a smaller environmental footprint than a traditional multiuse facility; however, the requirements for sanitization and cleanliness in biological drug manufacture place an extreme environmental burden on the multiuse traditional facility. Sanitization and cleaning is chemical, water, and energy intensive.
Single-use systems do not require such intensive sanitization efforts; their environmental footprints are more a result of their plastic content. Plastics are essentially paraffin-like chemicals with repeating chains of CH2 molecules. Given this chemical nature, plastics are indeed fuels. The preferred disposal method for such fuels is incineration, with or without energy recapture.
We have analyzed the cradle-to-grave carbon, water, and land footprints, calculated per single batch of a standard MAb, for a traditional fixed-in-place stainless-steel facility and a facility that relies on single-use equipment that is disposed of by simple incineration of all its plastic material. We have included the data from mining the iron ore through the diesel consumed in transporting plastic to the drug manufacturing facility as well as the transportation of waste plastic to the incineration facility, and the incineration of the plastic.
The Rise of Disposable Technologies
We have seen a rapid uptake of disposable technologies in the biopharmaceutical industry. Much of this growth has been in the last five years, although disposables have been around much longer in hospital settings, where they are used extensively. This increasing interest in disposable technologies has naturally been followed by a growing concern about the solid plastic waste generated from their use. This has been an area of interest of the authors who, early in the development and application of disposables, have tried to assess the impact of disposables at the facility level.1,2