Single-use systems (SUS) are used extensively in many situations for the production of clinical-scale quantities of biological drug substance. They are popular because they are relatively economic for smaller quantities, can be quicker to set up than fixed systems, and are good for minimizing cross contamination risk.
However, for commercial production, many companies remain to be convinced that disposables provide a better overall solution than fixed stainless steel systems. The skeptics tend to cite issues ranging from concerns such as cell-culture performance (variable growth rates), process integrity and leakage, implementation timelines, and integration problems. In practice, these risks and concerns are being addressed by suppliers and by increasing numbers of commercial manufacturers. What they are finding is that the flexibility and capital avoidance that results is worth the time and effort involved in fixing the problems.
Perhaps, more importantly, worries about change control, quality performance, and unforeseen supply-chain costs are also becoming significant as reasons for not adopting single-use technology. This is a crucial issue because use of SUS in the commercial environment involves significant volumes of equipment and financial risk. This area is where the industry is looking for better models of success from other industries.
Learning from other industries
There is no better learning to be taken than from the automotive industry when it adopted lean manufacturing principles during the 1980s and 1990s. The major players were plagued by poor quality, high inventories, lack of standardization, and adversarial relationships with suppliers. Control of quality relied on inspection after the process rather than prevention before the process. The solution lay in making the supply chain fit for purpose.
What this meant in reality was a relentless drive for quality at source and an uncompromising commitment to working cooperatively with suppliers to solve problems. To do this effectively the industry restructured by creating a tiered hierarchy of primary suppliers, and in turn, suppliers below them. A small number of major sub-system suppliers supplied the car manufacturers directly with various levels of subordinate suppliers feeding them. By organizing this way, it was possible to focus, at each level, on the controls needed to assure quality. In a virtuous circle, better quality led to confidence which led to single source supply and increased focus on a few key relationships. In addition to quality, just-in-time manufacturing and shorter lead times drove down inventories and the non-value adding costs of storage and handling. Complexity was further reduced at the design stage by establishing assembly platforms and late-stage customization. Car designers were free to innovate but only within clearly defined boundaries of standardization.
Applying best practices
So how can these approaches be applied to the biopharmaceutical industry and the special needs of a regulated environment? The following are best practices that form the basis of supply chain transformation of the SUS supply chain:
Ultimately, if single-use technology is to become a mainstream solution for the manufacture of commercial-scale biologics then the supply chain that provides the components and systems needs to become fit for purpose. Industry-wide focus on the best practices outlined will provide a firm foundation for that to be achieved.
About the author
Simon Chalk is director of the BioPhorum Operations Group, [email protected]
This article appears in the BioPharm International 2014 Single-use Systems eBook.