Pharmaceutical Technology Europe - October 2010 - (Page 2)

Our survey says... ingle-use systems are being used more and more in manufacturing, particularly in the manufacture of biopharmaceuticals. The time savings, reduced incidence of cross contamination, reduced need for cleaning and increased overall efficiency, to name a few advantages, make these technologies a very attractive proposition for manufacturers. There are, however, several obstacles to implementing the single-use systems, a key obstacle being manufacturers’ unwillingness to replace fully installed and validated technologies, whilst the lack of clarity in understanding the regulatory requirements for singleuse technology also presents a barrier. Notwithstanding the potential hurdles, a recent poll (Figure 1)* of Pharmaceutical Technology readers confirmed that the majority of companies (56%) are already using single-use technologies. Of S the remaining respondents, 18% admitted that they planned to use single-use technology in the future. So it is clear that, not only is single-use here to stay, but it could fully replace certain stainless steel technologies in the future. This month, Pharmaceutical Technology Europe, spoke with some experts in the field to understand the key advantages of the technology, the progress that is being made towards the development of template guidelines for users and suppliers, and to gain some predictions on the future role of single-use technology in pharma and biopharma manufacture. *www.pharmtech.com/polls Figure 1: Results of Pharmaceutical Technology Europe poll Q: Does your company use single-use technology for pharma/ biopharma manufacturing? Yes 56% No; company has no plans to use single-use technology in the future 27% No; company plans to use single-use technology in the future 18% 1 CONTENTS 8 MATERIAL COMPATIBILITY 3 HARNESSING THE ADVANTAGES 10 SINGLE-USE BIOREACTORS 6 CMO ADOPTION 11 QUALITY AGREEMENT TEMPLATE 7 VALIDATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/polls

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - October 2010

Table of Contents
Pharmaceutical Technology Europe - October 2010
Our Survey Says...
Harnessing the Advantages of Single-Use Systems
Should You Implement Single-Use Systems?
CMO Industry Adoption of Single-Use Technology
Validating Single-Use Systems
Material Compatibility and Single Use Systems
Achieving More Effective Cell Culture with Single-Use Systems
The Pros and Cons of Single-Use Bioreactors
Developing a Quality Agreement Template for Single-Use Systems
Ten Top Single-Use Technologies Showcased

Pharmaceutical Technology Europe - October 2010