Single-use or disposable bioprocessing technologies continue to gain greater acceptance within the biopharmaceutical industry and are now commonly used. The nature of the decisions that bioprocess engineers needed to make around single-use technology has changed since its introduction which was actually relatively early in the history of the biopharmaceutical industry. Early studies investigated whether manufacturing in disposable equipment was even feasible but once technical feasibility had been established the focus switched to whether there were economic or operational advantages in investing in the technology to a greater or lesser extent. Many bioproduction practitioners came to the conclusion that the benefits of single-use were real.
Single-use technologies: The economic case
From an economic perspective single-use technologies reduce capital expenditure on equipment and on utilities. Although the costs of consumables may have an upward pressure on the ‘cost of goods’ this is balanced to some extent by the reduction in costs of running steam, cleaning and water generating facilities used in stainless steel facilities to clean and sterilize re-useable equipment. The time taken to build and validate facilities is reduced as their complexity decreases which further reduces costs, however, critically it also allows the decision to invest in a facility to be delayed until the likely success of the biopharmaceutical product in the clinic is better understood. Given the high attrition rate of pharmaceutical products as they pass through the clinical trials process the benefit to the sponsoring company is significant.
Single-use technologies: The operations case
From an operations point of view, single-use technologies increase speed by reducing downtime required for cleaning and sterilization protocols and increase flexibility both by allowing multiple process configurations for different products to be implemented readily in the same facility and enable process modifications to be facilitated particularly prior to the process being approved by regulatory authorities. The quality performance of operations can be improved by using disposables as the risk of product and batch cross contaminations can be avoided, however, debates continue to rage regarding the nature and extent of testing that must be performed on the single-use parts to show that they have no impact on the safety or efficacy of the biopharmaceutical. Further, the nature of biomanufacturing operations must change to accommodate disposable with sponsors becoming increasingly reliant on the quality organizations of their suppliers. Sponsors must also consider the robustness of their supply chain ensuring the dependability of their own operations so that their biological medicines are always available to the patients that need them.
The future of single-use technologies
New single-use technologies are being developed and evaluated, companies are applying single-use concepts to increasingly diverse bioproduction processes and the technology is being utilized in new manufacturing paradigms such as continuous biomanufacturing. To an ever growing extent, however, the debate is switching from ‘if disposables should be implemented?’ or ‘to what extent?’ towards the questions about how to implement most effectively. Key questions remain on extractables testing, supply chain security, standardization and facilities designs that best accommodate single-use processes. All of these and more will be discussed at BioProduction 2015 in Dublin on the 14-15 October.
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Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker’s strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.