Freeze Drying in the Biopharmaceutical Industry: an Environmental Sustainability Assessment

Abstract Most biopharmaceuticals are produced as sterile parenteral preparations, requiring very strict production conditions. In addition, liquid formulations face stability challenges which is why currently around half of all biologics are freeze dried for preservation. The environmental impact of the fill and finish processes to produce a freeze dried biopharmaceutical (infliximab) was evaluated from two perspectives: (i) considering only process-specific needs and (ii) calculating the overall site needs. An Exergetic Life Cycle Assessment was conducted using both a bottom-up and top-down approach. The process-specific and overall site needs are 6.5 and 39.6 MJ ex /vial, respectively. These results reveal that 84% of the cumulative exergy entering the manufacturing plant is non-process specific. Electricity consumption is the highest footprint driver (86%), dominated by the Heating, Ventilation and Air Conditioning (HVAC) system running during non-production hours and/or supporting non-production related areas. If resource efficiency is pursued, the focal target might need to shift towards non-process-specific needs which are not essential for the product functionality/quality (e.g. full HVAC regime during non-production hours). It should be kept in mind that Good Manufacturing Practices conditions always have to be maintained. Currently performed energy saving measures addressing HVAC systems could potentially reduce the overall site needs calculated in this study by up to 16.5 MJ ex /vial.