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Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.
Biopharmaceutical companies around the world use disposable processing equipment for numerous reasons. According to Barres's 3rd Annual Report and Survey on Biopharmaceutical Manufacturing,1 they are to minimize or improve, in order of importance, cross-contamination, cleaning, time-to-start, capital investment, production cycle, and assurance of sterility. The priority varies, of course, according to a drug company's business objectives. For example, vaccine manufacturers regard cleaning and sterility as the most important reasons for adopting this processing model. Contract manufacturing organizations (CMOs) use disposable technologies because they minimize the risks of cross-contamination. Biotechnology manufacturing firms view disposables as a way to reduce capital investment.
But whatever their priority, most companies agree that disposables, also known as "single-use systems," make it easier to conduct their operations. Disposables can dramatically simplify the transfer of applications across multiple plants, because single-use systems are flexible, modular, and customizable. And if disposables already have been designed into the process elsewhere, qualification and validation are simpler. Training is easier, too, with disposables: The installation of reusable equipment is labor-intensive and costly, and their operation may vary significantly, depending on the age of individual systems. The consistency of disposable systems allows more universal operator training.
Disposables also eliminate the need for disassembly and cleaning, minimizing operator exposure to high potency formulations or biologically toxic compounds, such as new vaccines and cancer therapeutics. While operator risks associated with small molecules and synthetic drugs are significant, the hazards of working with live viruses in vaccine production are even greater.
Disposables are growing in popularity because of the large number of biological drugs being developed and produced, all of which require aseptic processes.
Table 1. Comparison of the time required to perform filtration various steps in monoclonal anitbody production when using disposable filtration systems for MAb.
The flu vaccine compliance failures of 2004 highlight the difficulties of ensuring the sterility of large-molecule drug products that can neither be heat-sterilized nor pass through a sterilizing grade filter. Disposables go a long way toward simplifying the complex task of achieving aseptic control and proving it to the FDA.
With global revenues for contract research and manufacturing projected to reach $168 billion by 2009, efforts to minimize cross-contamination risks have become a top concern for CMOs and contract research organizations.2 Many of these companies consider disposable technologies to be a key part of the firm's strategy to expand product lines without compromising safety. The ability to use filters, chromatography membranes, tubing, bags, and connection devices once, and then throw them away, means that there is no chance for batch-to-batch, or even more important, product-to-product, contamination.
Constructing a plant that incorporates disposable processing lines can shave several months off build time, during which a pharmaceutical company could potentially sell $200 million or more in drugs. Disposables require less space than conventional equipment, and they can be assembled into complete process trains offsite while the core facility is being built. These steps can reduce total construction time.
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Biopharmaceutical equipment suppliers recognize that disposable processing is the paradigm of the future, and they are pouring resources into developing new single-use technologies for both upstream and downstream processes. The recent introduction of a new disposable bioreactor based on shake mixing is an example of this. On the downstream side, many single-use innovations are being unveiled in the areas of tangential flow filtration and membrane chromatography.
As stand-alone disposable devices become integrated into multi-component assemblies, the time to market and cost-saving benefits increase significantly. Today's availability of disposable products is poised to turn single-use process trains into completely disposable factories.
Hélène Pora is marketing director, Pall Life Sciences, Pall France, 3 rue des Gaudines - B.P. 5253, 78175 Saint Germain-en-Laye Cedex-France, tel. +33.1.3061.32.20, fax 126.96.36.199.57.08, firstname.lastname@example.org
1. BioPlan Associates. Barre's 3rd Annual Report and Survey on BioPharmaceutical Manufacturing: Rockville, MD 2005.
2. "Outsourcing to Show Healthy Growth in Pharma."Business Communications' Pharmaceutical Contract Manufacturing and Research report cited in In-Pharmatechnologist.com, March 3, 2005, http://www.inpharmatechnologist.com/news/ng.asp?n=58484-outsourcing-to-show