Life Cycle Assessment of Albumin for Diagnostic Assays

Main Presenter:    Dr. Isolda Agustí-Juan 

Co-Authors:   Dr. Barbara Schmieg                                               

Due to its properties to bind a wide variety of organic and inorganic ligands, the albumin protein from bovine plasma is an important ingredient in many Roche diagnostic assays, acting as a stabilising agent or as a calibration substance (1). Maintaining the same supplier and quality ensures supply safety and constant quality. However, in recent years, non-animal based alternatives, such as synthetic proteins derived from the fermentation of single celled organisms, are being investigated as potential more environmentally-friendly options (2).
Aiming at a more sustainable albumin, a Life Cycle Assessment (LCA) (3) was conducted to evaluate the environmental impact of the current albumin production compared to an alternative process. The new albumin manufacturing process avoids the use of bovine plasma by using recombinant microbial fermentation and purification. Furthermore, standard raw materials for the recombinant process are advantageous concerning transport and storage conditions.
The comparative LCA analysed one batch of albumin produced with each production process scenario. The system boundaries included the raw materials production, packaging and transport and the albumin production (cradle-to-gate). Primary data was collected internally at Roche and the ecoinvent 3.8 cut-off was used as secondary data source. The IPCC 2021 GWP100 and Ecological Scarcity 2021 impact assessment methods were selected to obtain a holistic overview of environmental impacts for the two scenarios.
A challenge of the LCA was the estimation of environmental impacts associated with bovine plasma production due to the lack of data in commercial databases. The bovine slaughtering process produces products, such as beef meat for human consumption, and co-products such as bovine blood, from which the plasma is obtained. This multi-functionality was addressed with an economic allocation following EU PEF recommendations (4).
The LCA results showed the high environmental impact associated with bovine plasma for albumin production due to the use of the animal-based raw material. In contrast, the alternative manufacturing process with non-animal based raw materials showed a 77% reduction in GHG emissions. When looking at ecological scarcity, the impact categories with higher environmental impact in addition to global warming potential were heavy metals into soil, land use and water pollutants due to the cattle farming process.
The alternative process using recombinant microbial fermentation as basis for albumin production showed promising environmental benefits and further research should be carried out to determine the suitability of using this non-animal based material in diagnostic assays.

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