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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials.
Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials. An educational webcast by Pharmaceutical Technology, “Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies,” on Wednesday Mar. 6th examines this application.
Single-use technologies for producing clinical-trial materials may offer several advantages. Pharmaceutical products manufactured with non-dedicated equipment are at risk of being contaminated with traces of the previous product manufactured. This risk is reduced by equipment-cleaning regimes and cleaning verification/validation programs. Single-use disposable systems eliminate the risk of cross-contamination and reduce time and costs while meeting safety requirements for clinical-trial scale batches.
The 60-minute webcast, which will be broadcast live at 11:00 AM EST on Wednesday, Mar. 6, will focus on how single-use technologies improve the economics of manufacturing clinical-trial supplies for both sterile and nonsterile products. Although single-use disposable technologies have been widely adopted for sterile products, they have been used less often for nonsterile products, but can be equally effective and can lead to additional time- saving programs for Phase I clinical-trial materials. The webcast will provide case studies demonstrating the benefits and limitations of single-use disposable systems by focusing on single-use systems for sterile product manufacturing and for tablet and capsule manufacturing.
Audience members will be able to ask questions during the live webcast on Wednesday Mar. 6th at 11:00 AM EST. Additionally, the webcast will be available for on-demand viewing. Additional information on the webcast and how to register may be found here.