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The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
The use of single-use systems (SUS) in biopharmaceutical manufacturing has been steadily increasing. While the industry has used SUS in upstream processing for some time now, the use of single-use technologies is becoming popular in downstream processes as well. And it appears that the single-use trend will continue to grow. According to Nilesh Mehta, senior process engineer, Merck GTO, Sterile and Validation COE, “as new technologies become available or existing technologies are converted into a single-use format, the number of single-use systems used for biopharmaceutical applications will continue to grow.” The benefits of SUS may also influence the switch to SUS. Mehta states that the use of SUS in downstream processing may “reduce risk of cross contamination and carryover due to inadequate cleaning steps.”
BioPharm International spoke with Nilesh Mehta about the benefits and challenges of using SUS in downstream processing.
The Benefits of Single Use in Downstream ProcessingBioPharm: Are there specific aspects of downstream processing that benefit from the use of single-use systems?
Mehta: Yes, single-use systems provide significant advantage over traditional stainless-steel systems for downstream processing. Some examples are filtration systems, buffer preparation systems, and sampling/dispensing systems. Key advantages of using single-use systems are speed of implementation, which is crucial for high-impact new product launches, and increased operational efficiency related to a reduction in the resources required for cleaning and setup.
Normal flow filtration (NNF) systems are now available in capsule format; these systems are entirely single-use without any need for a stainless-steel holder. Systems can be designed, tested (with good scale-down models), and implemented fairly quickly without the need for procuring stainless-steel parts or developing related cleaning cycles.
Challenges of SUS in Downstream ProcessingBioPharm: What specific challenges do manufacturers face when using single-use systems in downstream processing?
Mehta: Extractables and leachables are usually a cause of concern with downstream processing, especially since product streams are fairly clean at this point and there may not be further processing that would clear anything that is introduced into the process stream from single-use components. Most often, the risk to a patient is fairly low and can be justified through understanding the type and amount of compounds that can potentially leach into product streams.
Material compatibility could also be an issue for downstream steps where organic solvents or harsh chemicals are used as part of a purification process. If there is not sufficient level of review to confirm compatibility with process streams or if all materials of construction in a given single-use system are not known upfront, this issue could easily be missed during initial design process and can result in re-work and delays during implementation./p>
Another challenge with single-use is related to amount of waste that is generated due to use of single-use systems. Diligent design efforts should focus on reducing amount of plastic and other materials used as part of manufacture of each single-use system to what is absolutely required to make the design work. Special efforts need to focus on minimizing amount of packaging material used to transport single-use systems from supplier to end-user. Smart packaging designs and use of recyclable/re-usable packaging material should help in significantly reducing waste generated and minimize impact on the environment.
Trends in Single-Use SystemsBioPharm: What trends are you seeing in the use of SUS in downstream processing for the future?
Mehta: Standardization of designs should allow for greater adoption and easier implementation of single-use systems in the future. This [standardization] will also reduce the risk of unanticipated failures related to untested designs or products. Having standards will also allow suppliers to focus on improving in areas of higher risk with respect to single-use systems while maintaining key features of standard design that have been proven to be robust through years of testing and use.
Article DetailsBioPharm International
Vol. 28, No. 7
When referring to this article, please cite it as S. Haigney, "Using Single-Use Technologies in Downstream Processing," BioPharm International, 28 (7) 2015.