The Disposables Revolution

The use of disposables has changed significantly in the biopharmaceutical industry.
Feb 01, 2008
Volume 21, Issue 2

Andrew Sinclair
The biopharmaceutical industry is less than 30 years old. It has evolved during a period of rapid change, both in the science base and the manufacturing technologies. In the early days, we did not have biopharmaceutical-specific manufacturing technologies and we borrowed equipment from other industries (the disk stack centrifuge from the dairy industry, for example) or relied on scaling up laboratory techniques, such as chromatography.

A revolution is currently taking place in our industry: we are now seeing rapid development of disposable technologies (sometimes referred to as single-use technologies). Much of this growth has been in the last five years, although disposables have been around a lot longer. Plastic blood bags were developed for blood collection in the 1950s and for the delivery of total parenteral nutrition (TPN) to sick patients in the 1960s. Even in the early days of biopharmaceutical manufacturing, we used plastic and silicone tubing. However, disposable bag technologies as we know them today came into being in the early 1990s.

In collaboration with you, the readers, I hope to investigate the benefits and drawbacks of disposables and identify the factors driving their dramatic growth in the industry. Through this analysis, we will better understand how to get the best out of disposable technologies. In this column, I will address the issues that the industry faces as users, designers, regulators, and suppliers. This column's purpose is to stimulate discussion and debate about the role and limitations of disposable technologies, and look into the future impact of this technology on our industry. Therefore, I seek from you feedback, ideas, and concerns, which you can email to
.In the industry today, we have widespread acceptance of the use of disposables. As a result, we have all the major suppliers running disposables development programs and investing substantially in the technology. Increasingly, there is consolidation in the suppliers as they strive to offer integrated whole process platforms; each supplier wants to be a one-stop-shop. The disposables revolution has only just started and there are significant challenges ahead that relate to standardization, implementation, regulation, environmental impact, supply chain management, technology functionality, and so on. For example, is it feasible or desirable to have a totally disposable manufacturing process? If so, is it all going to be single use? These are themes to which I will return in later columns.

It will be useful to look back to see how far we have come and to look to the future. To get a supplier's and a user's perspective, I consulted the joint co-chairs of the ISPE Community of Practice (COP) for disposables1—Miriam Monge, former director of marketing for Stedim Biosystems, and Adam Goldstein, a senior manager at Genentech's Oceanside facility.

Miriam has worked for Stedim since 1994 and was instrumental in raising awareness of the benefits and uses of disposable fluid handling systems. Stedim was an early developer and promoter of disposable bag technologies: this grew out of its TPN bag business and was driven by customer demand, e.g., wanting larger bags manifolded together. In those early days, the move to bags larger than 50 L required a radical rethink of the conventional two-dimensional bag design. This led to the development of the three-dimensional range comprising bag and the containers in 1998. To develop the business, it was important to work with end users: in Stedim's case, this involved working in partnership with the GlaxoSmithKline biologics vaccines division to achieve solutions we now take for granted, such as how to make aseptic connections, improving ergonomics of the bag containers, and working with the regulatory affairs department to define standards for disposables interaction studies in compliance with worldwide regulatory requirements. The major challenges in those early years were people related: the industry is conservative about novel technologies and adoption of disposables was a radical departure from traditional stainless-steel systems. But there were early adopters and a lot of these early adopters were driven by specific process needs in existing facilities that were not easily addressed by conventional technologies.

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