SUPERVISOR: Alois JUNGBAUER

PROJECT ASSIGNED TO: Felix DIERINGER

Biologics are the fastest growing segment in the pharmaceutical market with an estimated compound annual growth rate of 8-10% to 2028 [1]. With growing demand, environmentally sustainable production of biologics has become a top priority and many major biopharmaceutical companies have joined the Science Based Targets initiative (SBTi) [2]. However, quantifying the environmental impact of a process remains a challenge. While comprehensive Life Cycle Assessments (LCAs) are time and resource intensive, simple metrics such as Process Mass Intensity (PMI) only measure material efficiency rather than the true environmental footprint [3]. Therefore, a new tool to calculate the sustainability of a process and enable informed decision-making during process development is envisioned.

It is hypothesized that continuous biomanufacturing will be the key element to reduce the environmental impact of biologics manufacturing processes. Studies have shown that heating, ventilation, and cooling (HVAC) energy consumption for cleanrooms is a major impact factor across all assessed impact categories [1, 4]. Continuous processes can significantly reduce equipment sizes compared to traditional batch processes. The material input (PMI) is comparable between the two technologies [5]. However, perfusion bioreactors can enable recycling of spent media which meaningfully reduces media consumption [6]. Although downstream recycling strategies have also been published [7, 8], recycling is not well established in the biopharmaceutical industry yet.

Using ecologic and economic modeling softwares such as BioSolve (BioPharm Services) and SuperPro Designer (Intelligen) this thesis aims to create a better understanding of the environmental benefits of continuous bioprocessing and recycling strategies.

 

1.            Argoud, S., et al., Green metrics for biologics. Current Opinion in Green and Sustainable Chemistry, 2022. 35: p. 100614.

2.            [cited 2024; Available from: https://sciencebasedtargets.org/target-dashboard.

3.            Budzinski, K., et al., Introduction of a process mass intensity metric for biologics. N Biotechnol, 2019. 49: p. 37-42.

4.            Budzinski, K., et al., Streamlined life cycle assessment of single use technologies in biopharmaceutical manufacture. New biotechnology, 2022. 68: p. 28-36.

5.            Madabhushi, S.R., N.D.S. Pinto, and H. Lin, Comparison of process mass intensity (PMI) of continuous and batch manufacturing processes for biologics. N Biotechnol, 2022. 72: p. 122-127.

6.            Madabhushi, S.R., et al., An innovative strategy to recycle permeate in biologics continuous manufacturing process to improve material efficiency and sustainability. Biotechnology Progress, 2022. 38(4): p. e3262.

7.            Jungbauer, A. and N. Walch, Buffer recycling in downstream processing of biologics. Current Opinion in Chemical Engineering, 2015. 10: p. 1-7.

8.            Satzer, P., A risk-aware assessment for buffer recycling across unit operations for monoclonal antibody purification and its potential. Biochemical Engineering Journal, 2024. 201: p. 109140.