Single Use Bioreactor Equipment: Justification and Sustainability?

Please find below the abstract for the report titled:

Single Use Bioreactor Systems: Justification and Sustainability?

A draft poster is available to accompany this abstract upon request.

Thank you for your consideration

Yours Sincerely

Jordan Harrison

Abstract

This report provides an assessment of the justification, and sustainability of single use bioreactor systems (SUBS). Bioprocessing in general is addressed in this report, however focus is concentrated on the production of various forms of Biopharmaceuticals. Justification is assessed on the grounds of financial viability, and operational practicality. Sustainability is evaluated though the calculation of the total carbon emissions from comparable SUBS and traditional re-usable systems.

The production of Biopharmaceuticals encompasses a range of processes with considerably differing operational requirements; This therefore presents an inherent challenge to provide a general justification for the use of SUBS. To address this issue, this report begins with a comprehensive examination of the frequently cited advantages and limitations of SUBS. This is then analysed to determine the most significant and common factors of consideration when justifying the use of SUBS. The primary parameters that were identified include: Compatibility, scale, product value, and throughput.

The validity of these findings is then tested by considering their applicability in the context of a variety of bioprocess applications (including: gene therapies, antibody treatments, and Vaccine production). This testing process validates the proposed considerations, and illustrates to the reader the significant difference in challenges and requirements for SUBS within bioprocessing. Additional consideration is given to the business model that is applied to a bioprocess. This analysis identified small scale, flexible, multi-product facilities as being ideally suited to utilising SUBS. Conversely, Industrial scale productions, and microbial fermentation processes are highlighted as best suited to reusable facilities. The business model most ideally suited to benefit from the integration of SUBS was found to be contract development and manufacturing organisations (CDMO’s).

This detailed assessment is then summarised to produce a generalised justification flowchart which presents the key criteria required to assess the suitability of a process to the use of SUBS. This flowchart can serve as a starting point to determine if further process specific assessments are warranted for the integration of SUBS.

Economic assessment concludes that where the use of SUBS is feasible, an economic benefit can be achieved. This is largely due to increased flexibility in operations, as well as in facility design. Reductions in cost of goods manufactured (COGM) can be achieved by enabling process streamlining and de-bottlenecking. Sustainability is assessed by comparing the energy consumption, materials consumption, and waste production of SUBS in comparison of traditional multi use (MU) facilities. The high expenditure of energy required in the cleaning and sterilisation of MU systems makes traditional MU facilities less sustainable than SUBS processes.

The production, supply chain, and future of SUBS industry is also examined in this report. It is concluded that the SUBS market share will increase significantly as the industry matures. This is a result of increasing applications, and improvements in component reliability; as experience in usage increases and the necessary supply chain control is established.