March 20 – 23, 2022
The sales of biologics will reach over $300 billion in 2020 and the market continues to have accelerated double-digit growth under the COVID-19 burden, thus biopharmaceutical companies continue to pipeline biologics for a mounting global patient base. Nevertheless, biologics are changing and the needs of their manufacturing are changing with them. Emerging biologics (e.g., antibody–drug conjugates, viral vectors, mRNA, bi/multi-specifics) are coming with complex or lean manufacturing requirements. Additionally, the global market is searching for more affordable & sustainable biologics and biosimilars, creating an increasingly competitive space within the emerging countries who seek to manufacture locally.
The BioPhorum Operations Group (BPOG), a cross-industry organization of biopharmaceutical end users and suppliers collected biopharmaceutical industry drivers stating;
- 90% reduction in capital expenditure (CAPEX) and manufacturing costs in the next decade.
- reduce product changeover times by 90% to improve responses to variability in demand
- drive down new facility build times by 70%
The question is, how does this translate to actionable and prioritized points of improvement for a biological implementer & supplier to work on?
With this general need in mind, combining Design Thinking methodology and insights from single-use biological manufacturing users were gathered through an extended survey with key biopharma industry companies and institutes representing the various user groups. All interviewee responses were populated, to enable the categorization and sorting of distinct user perceptions of likes, pain-points, and benefits. The outcome of the survey was thestarting point to define what are the critical components for a sustainable technology roadmap to address the needs for the rapidly intensifying biologics manufacturing market.
In the presented work will be an overview of these validated pain-points, an explanation of the corresponding technology characteristic which address the underlying user need and a journey along the downstream purification steps. The format will be interactive with feedback questions and presentation of anonymous answers from the audience. The presentation will finish with concluding remarks on how sustainable single use processing could benefit the manufacturing of biologics.
Stuart Tindal, Ganesh Kumar, Fritjof Linz, Michael Koch, Fabien Rousset, David Johnson, Franziska Froboese, and Geert Lissens, "Addressing the pain-points of single-use intensified multi-product downstream and liquid processing in a dancefloor production room layout" in "Single-Use Technologies V: Building The Future", Magali Barbaroux, Sartorius, France; Martina Micheletti, University College London, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/sut_v/10