(135d) A Vision to Create a Framework for the Biopharmaceutical Industry to Approach Maximum Sustainability

In the 80 years since the first commercialised product¹, advances in biotechnology, particularly the development of modern (recombinant DNA) technologies, have enabled the treatment of diseases that were once thought to be untreatable, such as Leukaemia^2â??4. The production of biologics is expanding beyond the US and Europe to developing countries with the emergence of biosimilars and biobetters^5,6. As the industry matures, the focus is shifting away from breakthroughs towards sustainability. Research on the industry is required to quantify the environmental burden, and diagnose areas for improvement before future manufacturing recommendations are made. Life cycle assessments (LCAs), aided many industries in the past^7â??9, are comprehensive environmental impact studies, which consider systemsâ?? raw material extraction to their end of life, a tool that aids decision making for future development. However, a framework needs to be developed to ensure resulting recommendations are fully adopted. This paper sets out to analyse the influences on the industry and, from these findings, to present a strategy utilising LCA for the support of continual sustainable development.

There are five major parties that influence biopharmaceutical decision makers: academia, government, non-governmental organizations, the general public and companies' own stakeholders. The level of risk inherent developing a new drug to market is exceptional. The industry is very capital intensive¹⁰. This poses risk on stakeholdersâ?? return. It is in their interest to maximise profit and realising that improving processes reduces cost, sustainable actions are hence chosen. Academics hold some of the fundamentals for the drive to sustainability. Not only they can provide on-going advances in technology for companies to migrate from an unsustainable state to a more sustainable situation¹¹; their knowledge and reasoning are cascaded down into education and awareness-raising in our society. The general public have learnt to scrutinize those that do not take the environment into consideration, forcing companies to show leadership in the subject matter to increase social standings to gain competitive advancement¹².

While actions taken towards sustainability might be motived to advance a company economically and socially, it is governments and NGOs policy enforcers and practitioners that ensure industry abides to environmental rules. Laws and regulations have been implemented to reduce pollution due to development and manufacturing waste. However, governmental legislations are often not industry specific and tend to focus on energy intensive industries (EIIs) when it comes to reducing environmental issues. The regulations that have passed are normally set limits that companies and organizations must adhere to. However, EIIs frequently fail to do this^11â??13and on the contrast, the biopharmaceutical industry tends to operate at lower scales, and many individual companies do not reach these governmental limits. Governments have the power to implement industry specific policies to ensure maximum sustainability can be approached by all industries. The biopharmaceutical industry is not currently regarded as an EII but, as it grows, the collective environmental impact can be significant. It will be beneficial to put environmental constraints in place for this developing industry to minimize future burden.

To ensure maximum sustainability is approached, academia, industry and government should work closer together. There are two types of approaches where scientific research can be used to influence policy: (1) data-first â?? fitting research to governmental bodyâ??s agenda and (2) co-design and co-production â?? collaborating with government to solve a common issue^15,16. Although time consuming, the advantage of co-design is the full adoption of research knowledge into policies. LCA calculates a systemâ??s sustainability with regards to selected environmental metrics; economical and social metrics can also be implemented to give full analysis of the industryâ??s status. The comprehensive results can formulate concise and accurate legislation for the single industry. The socioeconomic aspects will prove the relevance and impact of the research, persuading companies that improving environmental sustainability will not come at a cost.

A visionary strategy is to develop a feedback framework by co-design wherein initial analysis informs industry specific legislation based on the specific LCA metrics that has been agreed between research and government. Recommendations and guidelines on biopharmaceutical processes such as the amount of waste per kilogram of product, and carbon emissions can be imposed on the industry as sustainability targets. Then, as new technology arises, new data can be produced which again feeds back to legislators and the resultant recommendations are revised. However, the process for analysing the whole industry is data intensive. There will be implications in gathering accurate results due to the lack of data available. Not only are there few studies on the environmental impact of the industry, but current processes may be subject to non-disclose agreements, which suggests process data is highly sensitive. Partnership between academia, industry and government should be established to ensure the accuracy of acquirable data.

In conclusion, the paper demonstrates the fundamental importance of academia and government in increasing sustainability in the biopharmaceutical industry. Moving from unsustainable to a more sustainable future is a continual process, a feedback framework, indicating sustainability status, developed by the two most influential parties should be implemented to maximise the benefits of new technologies and process methodologies. LCA has transformed industries in the past; co-design and co-production of research knowledge using LCA as a tool is the key to transform legislation to take leadership in continually driving sustainability.

References

1. Quirke V. History of Penicillin. eLS. 2001:1-3. doi:10.1016/S0140-6736(80)90580-2.

2. Rader C. Chemically programmed antibodies. Trends Biotechnol. 2014;32(4):186-197. doi:10.1016/j.tibtech.2014.02.003.

3. Abegunde D. Background Paper Essential Medicines for Non-Communicable Diseases ( NCDs ) Essential Medicines for Non-Communicable Diseases ( NCDs ).; 2011.

4. Projan SJ, Shlaes DM. Antibacterial drug discovery: is it all downhill from here? Clin Microbiol Infect. 2004;10 Suppl 4:18-22. doi:10.1111/j.1465-0691.2004.1006.x.

5. Langer ErS. Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.; 2015.

6. Wilsdon T, Attridge J, Fiz E, Ginoza S, Mitchell-heggs A. Assessing the value of biopharmaceutical innovation in key therapy areas in middle-income countires. 2015;1.

7. Hunt R, Franklin W. LCA â?? how it came about. Int J Life Cycle Assess. 1996;1(1):4-7. doi:10.1007/BF02978943.

8. Economy GF, Regulations VE. LCA of Automobile Industry. Phoenix Syst - Process Strateg. 2009.

9. Klöpffer W. Life cycle assessment: From the beginning to the current state. Environ Sci Pollut Res Int. 1997;4(4):223-228. doi:10.1007/BF02986351.

10. DiMasi JA, Feldman L, Seckler A, Wilson A. Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs. Clin Pharmacol & Ther. 2010;87(3):272-277. doi:10.1038/clpt.2009.295.

11. Scott C. Sustainability in Bioprocessing. Vol 9.; 2011.

12. Li W, Yu R. Environmental Responsibility and Biopharmaceutical Companies: Developing a Competitive Strategy. 2011:51-54.

13. Affair VP. Compliance in Manufacturingâ?¯: A Very Personal Affair. 2013:1-11.

14. Zhou J. Pesticide Manufacturer Fined 12 Million USD In Accordance with Chinaâ??s New Environmental Protection Law | chemical. https://chemlinked.com/news/chemical-news/pesticide-manufacturer-fined-1.... Published 2015. Accessed April 28, 2016.

15. US EPA, OECA, OAP I. Civil Cases and Settlements. 2016. https://cfpub.epa.gov/enforcement/cases/. Accessed April 28, 2016.

16. Pohl C. From science to policy through transdisciplinary research. Environ Sci Policy. 2007;2. doi:10.1016/j.envsci.2007.06.001.

17. Majone G. Evidence, argument, and persuasion in the policy process. 1992:1-9.