The Next Horizon: Single-Use Technologies for Finished Drug Product Manufacturing

March 4, 2013
Patricia Van Arnum

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.