Single-Use Technologies – The Perspective of an End User
25th March 2015 | 3:00AM ET / 8:00AM GMT / 9:00AM CET / 4:00PM SGT | Ciarán Kelleher, Senior Principal Engineer, Janssen and Barbara A Paldus, Chief Executive Officer of Finesse Solutions |WATCH FOR FREE
Today use of the term “single use technologies” can be considered as being synonymous with the modern biotech industries. Based on the proliferation of companies now specialising in providing solutions to pretty much anyone anywhere, along with the intensive level of marketing and industry discussion, it is clear to see that the sector has progressed significantly over the years. The ability to purchase systems and technologies off the shelf as a consumable, rather than invest in significant capital infrastructure, better facilitates small enterprises to perform small and pilot GMP scale manufacture in-house. Organisations are able to leverage the experience of the manufacturers in the development of these products. The concept of single use technologies has been proven to produce solutions which are compliant and work. However, there still are questions around regulatory guidance for single use technologies.
Ciarán Kelleher is a Senior Principal Engineer with the Global Technical Services organisation within Janssen. His specific areas of expertise are in process and equipment design. Ciarán holds a B.Eng(hons), in Chemical and Process Engineering from the Cork Institute of Technology. He currently sits on the subcommittee on System Design within ASME –BPE and is a member of the task group on Disposables within BioPhorum Operations Group (BPOG).
Sponsored by Finesse Solutions LLC
California-based Finesse Solutions brings Silicon Valley Technology to Bio-processing. Better performance, integrated intelligence, and plug-and-play bio-process flexibility are provided by Finesse SmartParts™. Our TruFluor® single-use sensors are unparalleled in the industry. Our G3 Universal™ controllers enable sophisticated cell culture or fermentation recipes to run on any size or brand of vessel. Our TruBio® software provides an easy-to-use interface for upstream bio-processing that can harmonize old and new equipment, aggregate in-line and off-line data, and electronically facilitate global technology transfer. Finesse enables you to supercharge your R&D laboratory or scale-up to a cGMP SmartFactory with equal ease: we offer complete services, including commissioning and validation. We are the people for bio-process management.
Dr Barbara A Paldus, a co-founder of Finesse Solutions, Inc and serves as its Chief Executive Officer. She founded Picarro in 1998 and has served as the Chief Technology Officer. At Picarro, which she also founded while a post-doc at Stanford University, she was responsible for technology strategy, research innovation, and product/business development. She received a Ph.D. in 1998 and M.S.E.E. degree in Electrical Engineering in 1994 from Stanford University. Dr. Paldus received her B.S. in Electrical Engineering and applied mathematics from the University of Waterloo, Canada, in 1993.