Biologics encompass a wide variety of drugs including monoclonal antibodies, fusion proteins, nanobodies, vaccines, and enzymes, among others. With the biologics market volume increasing at a rapid rate, there is a need to assess the efficiency of manufacturing processes to better understand their environmental impact. In 2008, the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable (ACS GCIPR) recommended using PMI as the benchmarking metric to evaluate manufacturing processes and to drive greater efficiency and innovation in the pharmaceutical industry. A previous study, which included data from six different companies, showed that the PMI for monoclonal antibody (mAb) manufacturing processes can range from 2,000 – 25,000. Here, we calculated the PMI of various monoclonal antibody processes at Merck to generate an internal PMI range for our manufacturing processes. Furthermore, we compared the data to non-mAb biologics (i.e. nanobody and vaccine) processes to gain insights into the similarities and differences between them. Based on the lessons learned, potential strategies were identified to improve manufacturing efficiency. This work demonstrates that PMI can be used to guide the development of more efficient and environmentally sustainable manufacturing processes.

Applying PMI (process mass intensity) to compare the environmental footprints of biologics manufacturing processes: Case studies for monoclonal antibodies, nanobodies and vaccines

2019 Spring National Meeting

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