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The use of disposables has changed significantly in the biopharmaceutical industry.
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 email@example.com.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.
Miriam's experience with Stedim mirrors both my and Adam's experience. In my case, at Lonza in Slough, we had a big problem with buffer handling in stainless-steel containers. The use of hold bags for buffers streamlined the whole operation and freed up production floor space for more capacity. Early in his career, Adam worked for a small biotech company that did not have the money to put in a conventional facility. Adam worked with Biowhitakker, a bag supplier, to look into using them to provide bags for holding buffers. However, the challenges he faced were considerable: the bag designs were rudimentary and he had to work with Colder Products to sort out the methods for making aseptic connections. Adam used this experience to challenge the likes of Stedim and Pall to offer something better.
As the industry has matured and the suppliers have developed technologies for sterilization, design, and integration of components (filters, tubing, and aseptic connectors), acceptance for the use of disposables for handling solutions has become widespread. We have reached the point where handling solutions in bags is commoditized and every supplier must have the capability of providing solution-handling systems. The future challenges are technical, business, and cost related. From Adam's perspective, the technical focus for the future has to do with development of the disposable downstream components such as GE Healthcare's disposable column. This will complement the advances in disposable cell culture bioreactors and contribute to achieve a totally disposable process.
Leaving aside the technical challenges, Miriam's view is that although standards may be being set in the arena of extractables and leachables, and sterility requirements, there is currently little attempt by the suppliers to standardize across product ranges. Such standardization would allow the end user to interchange bags between two suppliers working with the same support container. Lack of standardization complicates both the qualification of multiple suppliers and supply chain management. Such cost and business-related issues will come into sharper focus as disposables integration becomes the norm. There is a need for an industry forum where interested parties can debate competing claims: the ISPE is to be commended for setting up a Community of Practice for disposables. I will be returning to these and other issues in the future columns and welcome your input.
Andrew Sinclair is the managing director of Biopharm Services, Chesham, Bucks, UK, +44 (0) 1494 793 243, firstname.lastname@example.org International Society of Professional Engineers (ISPE) set up a Community of Practice for disposables in 2007 whose mission aims to create a global focal point of support for biopharmaceutical professionals working with single-use disposable technologies. http://cop.ispe.org/COP/DisposablesCOP/