, , , , ,

Femi OlawuyiFemi Olawuyi is a graduate student of Biotechnology Department, University of Maryland University College (UMUC), Md, and an AAPS graduate student member.

Single-use systems are gaining popularity and relevance in the production of biopharmaceutical products. Until recently, the drug substance production process relied heavily upon hard-piped assemblies and typical stainless steel equipment. The introduction of end-to-end disposable single-use systems in manufacturing biopharmaceuticals has brought along many benefits, such as increased product throughput, reduced lead times, reduced cleaning and associated cleaning validation of production assemblies, enhanced safety for production facility operators, lower capital investment, and minimal or eliminated cross contamination with other substances in the manufacturing facility. These advantages have made it possible for drug manufacturers to invest in cost-effective single-use production facilities that manage several batch sizes and volumes of multiple drug product campaigns.

Since the advantages and capabilities of single-use systems offset those of conventional, reusable systems, they have positively influenced the production of pharmaceutical products that require very high levels of purity such as vaccines and monoclonal antibodies. I’m intrigued by a 2011 trend report on single-use systems produced by the Society for Chemical Engineering and Biotechnology (DECHEMA), which underscores how single-use technologies are assembled with parts made of plastic and not intended for reuse so as to minimize the risk of cross-contamination during drug production.

To better understand how single-use systems are applicable to clinical manufacturing, I reviewed and gathered the following examples of single-use technologies from Pall Corporation:

• Sterile connectors that allow the sterile connection of two sterile entities in all types of environments

• 3D biocontainers, a large range of process bags with improved features for connection purposes and drainability

• Capsule filters with the widest range of filter media and connection capabilities

• Tangential Flow Filtration devices in a variety of configurations to match application requirements

• Single-use Mustang chromatography capsules for capture and polishing applications

While I’m captivated by the benefits of all these single-use systems, some limitations are obviously noted as compared to conventional systems. The disposal of all these single-use products poses a great ethical challenge to the biotechnology industry in terms of the potential risk of causing environmental hazards. Another limitation is that most single-use systems require manual intervention during production compared to conventional systems. The DECHEMA trend report states that the level of automation on these systems is generally lower than comparable conventional systems, and since most disposable systems are produced manually, it is either very difficult or impossible to verify integrity at the user site. Hopefully the next generation of single-use technologies will overcome these obstacles by making sustainability and automation issues a priority.

More About the Author
Femi Olawuyi is a graduate student of Biotechnology Department, University of Maryland University College (UMUC), Md, and an AAPS graduate student member. He is also the creator of www.biograduate.com, an informal, information-sharing portal for graduate students in biotechnology-related disciplines.