Single-use technologies for biopharmaceutical drug production help reduce the risk of contamination, increase operational efficiencies, and cut capital expenditures, both fixed and consumables costs.
These systems come pre-sterilized, eliminating the need for cleaning and sterilization and significantly reducing setup and changeover times. As a result, single-use systems also provide flexibility and enable manufacturers to quickly make changes in response to market needs.
Now that the technology has evolved, single-use products have pushed beyond an early-stage technology and are emerging into larger, commercial-scale operations. The advent of single-use devices is already having significant impacts on the commercial manufacturing process and is likely to create even more sweeping changes in the pharmaceutical processing landscape.
Leachables and Extractables
But, the growth of this technology comes with some challenges manufacturers need to consider. One critical issue is the safety issues associated with leachables and extractables. Since most single-use products are constructed of polymeric materials they have the potential to introduce leachables into the manufacturing process—affecting the safety and efficacy of the product.
Assessing the risk posed by any given leachable can be challenging, be it from a container closure system or the biomanufacturing process. Single-use components are often constructed of numerous functional components such as bioprocess bags, tubing, and filters, each potentially made from different types of plastic and/or rubber.
The challenge is that suppliers have not yet been able to agree on standardization—they all want to be able to standardize according to their own respective needs. Additionally, sterilization, the addition of wetting agents, and other pretreatments of such assemblies can create leachables that are unrelated to the material making up the assemblies.
Due to the lack of standards, each supplier has its own view of the tests that need to be done, leaving it up to the end user to define, in the framework of the components being used, their own testing protocol. These leachable and extractable studies can be costly and complex. Standardization would help considerably. Several organizations are working on draft standards, including the American Society of Testing Material (ASTM). Standardization will go a long way to aid the growth of single-use technology.
Biopharma Slow to Adopt
While single-use technology has made inroads in the biopharmaceutical industry, the adoption of continuous processing is still in its infancy. But, for processors looking to improve efficiencies, single-use systems and continuous manufacturing are complementary technologies.
With continuous manufacturing, implementation of continuous monitoring, which increases process reliability over batch testing, becomes a reality. Continuous monitoring enables manufacturers to detect problems or abnormalities in real time, potentially improving the overall quality of the product.
The U.S. Food and Drug Administration (FDA) has encouraged manufacturers to adopt continuous practices because of these safety and drug quality improvements. Continuous manufacturing also reduces variability between individual batches, therefore reducing the likelihood of adverse effects with patients.
While continuous manufacturing is well-established in industries such as automotive, pulp and paper, and food production, the biopharmaceutical industry has been slow to adopt. This is in large part due to a lack of regulatory guidance and concerns about validation and approval.
Complications and Costs
All good manufacturing practices (GMPs) have been written for traditional batch processes, and therefore shifting to new methods entails some complications and costs. For manufacturers of products like generics, with low-margin profits, the costs of shifting to continuous methods may not justify the long-term improvement in efficiencies.
As continuous processing gains a better footing, a new generation of single-use continuous manufacturing systems is being developed to fit an ongoing processing landscape, pairing these complementary technologies.
The success of single-use systems will require innovative leadership to ensure standardization and the right process documentation to encourage continuous processing. Industry experts believe process simplification will be the real driver for single-use success. Suppliers of single-use systems are likely to see profitable opportunities as they look beyond the current new product strategy of simply replacing stainless steel with plastics.
Single-Use on Display
Produced by PMMI, The Association of Packaging and Processing Technologies, Healthcare Packaging EXPO focuses on packaging for pharmaceutical, biotech, and medical device manufacturers. The organization represents more than 800 North American manufacturers and suppliers of equipment, components, and materials as well as providers of related equipment and services to the packaging and processing industry.