The process development of medicinal products is an avenue which is currently being carefully investigated for its environmental sustainability. Roche is one such pharmaceutical company that aims to reduce its environmental impact, in line with its goal of achieving net zero carbon emissions by 2050.
However, carbon isn’t the only factor. As Katharina Bruno-Thakur, Principal Scientist at Roche explains, reduction of environmental impact also involves the phasing-out of substances of high concern, general energy efficiency, and the reduction of plastics. Bruno-Thakur illustrated Roche’s efforts with a case study which assessed the environmental cost of shipping a lyophilised product versus liquid drug substance.
Typically, oligonucleotides are produced by solid phase synthesis, purified, and lyophilised for transport to the drug product manufacturing site. There, they are dissolved again and processed further. This case study examined the possibility of skipping the lyophilisation step and directly shipping the liquid drug substance to simplify the process. The project specifically looked at lyophilisation and the subsequent transport, storage, and dissolution phases.
The process starts with a Life Cycle Assessment (LCA) which is broadly used to measure the environmental impact of human activities. This process begins by identifying the goal and scope of the assessment, defining the unit of analysis to ensure consistency of comparison, and setting out the scenarios and system boundaries.
Then comes the trickier task of inventory analysis where teams collect data about their operations which is analysed using software to return metrics like CO2 equivalents or eco-balance points. Data was collected from internal sources and databases, considering factors like energy consumption, packaging, transport, and storage.
The study found that lyophilising and transporting drug substances as powder is more than four times more impactful than transporting them as liquid, with lyophilisation being the main driver of the environmental footprint. This is the case even when factoring in the additional impact of heavier transport burdens and storage at -20°C.
Going forward, Bruno-Thakur concluded that refining input parameters and expanding boundaries in the LCA could help further reduce environmental footprints, supporting Roche's environmental goals.