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Because disposable systems offer benefits that can impact the time for development as well as for the cost of production, the biotech sector is expected to continue to use these technologies ...
Single-use disposable technologies have been available long before the advent of biotech. Research, drug development, analytical and QC labs transitioned into disposables during the 1970s, and at the start of today's biotech industry, over 25 years ago, early manufacturing applications included small capsule filters for vents and liquid capsule filters for product and buffer filtration.
Jerold M. Martin
The biotech sector continues to expand the use of disposable technology in processing operations. More recent applications extend beyond filtration and storage to include membrane chromatography (in single-use disposable capsules) and tangential flow filtration (TFF) systems. Some benefits of single-use systems are described here.
Streamline operations. During the early stages of biotech product development, it is important to evaluate technologies and make preclinical and clinical batches quickly. The use of disposable products can help to streamline operations during these stages.
Save time. By streamlining operations with preassembled, presterilized systems, time savings can be achieved throughout the production process — from initial assembly to disassembly post-use. In situ or autoclave sterilization can be eliminated completely, which saves time and also reduces or eliminates maintenance required for steaming equipment. Additionally, time between manufacturing campaigns can be decreased.
Reduce validation requirements. Sterilized reusable systems also require sterilization validation; and both sterilized and nonsterile reusable systems require cleaning validation and removal of cleaning agents. These operations can require considerable time and labour. Sterilization validation of presterilized assemblies, however, can be conducted by the supplier, which eliminates the need for autoclave or steam-in-place (SIP) process validation by the user. In some cases, this can even eliminate the need for an autoclave or steam generator. The disposability of these systems also eliminates cleaning validation for this process step and may significantly reduce overall cleaning validation.
Operate safely. Safety is always an important consideration and disposable systems can provide increased personnel safety as SIP operations are not required, and operator contact with process fluids and cleaning agents can be reduced or eliminated. Disposable components are typically lighter than equivalents used in hard-piped systems, making operator handling easier and safer.
These drivers have led to increased use of disposable technology, causing biotech suppliers to offer an on-going stream of new disposable capabilities. There are new disposable methods for sampling as well as for making aseptic (sterile) connections. New technologies that are good examples of recent enabling technologies for single-use processing include:
Disposable membrane chromatography systems. Membrane chromatography is an increasingly applied new technology where chromatographic separations are performed at the interior and exterior surfaces of microporous membranes. This offers significant advantages compared with traditional beaded resin column chromatography in terms of footprint, process time and, in particular, capacity for large biomolecules.
Disposable TFF systems. Tangential flow ultra-and microfiltration systems have continued to be performed in hard-piped systems with piping and membrane cassettes repeatedly cleaned and reused. Concerns of cleaning efficacy and batch-to-batch carry-over of contaminants from TFF systems has driven interest in single-use for these systems.
Scale of disposable systems. Components are currently available for fully disposable processes with initial batch sizes up to 2000–3000 L. This makes disposables ideally suited for pilot-scale operations and clinical batches, as well as production of patient-specific drugs, gene therapies, vaccines, high potency recombinant proteins and cytotoxic agents. Because disposable systems offer benefits that can impact the time for development as well as for the cost of production, the biotech sector is expected to continue to use these technologies and increase demand for further developments of disposable processing approaches.
Jerold M. Martin Is a senior vice president at Pall Life Sciences, USA.