Pharmaceutical Technology Europe - October 2010 - (Page 6)

CMO industry adoption of single-use technology More of our pharmaceutical clients are becoming familiar with single-use technology and, if we take time early in our discussions to explain options and any potential benefits to them, clients will often be open to suggestions for its use. In projects that have particularly aggressive timelines, a single-use solution is one tool that our clients are beginning to consider more frequently, given that their use is generally associated with time savings. Single-use systems have the potential to provide significant cost advantages to both the contract manufacturer and the client, including: • reduced capital expenses • reduced project initiation to manufacture lead time • elimination of cleaning validation • better space utilisation • reduced support system cost (i.e., WFI, clean steam, power, time). Changing client mindsets One of our challenges is educating clients on the potential benefits versus risks of single-use systems. Our clients are often more comfortable using traditional manufacturing systems because innovations can be perceived as introducing risk to a programme. If we believe that a client would benefit from the use of single-use technology and they opt to implement it, the most important consideration that follows is product compatibility with the single-use system and evaluation of extractable/leachables from the equipment. Overall, single-use manufacturers have offered good definitions on what can be extracted Mark Krusz ynski and pharmaceutical manufacturers. Innovations of any kind that potentially enhance speed to market for our clients need to be evaluated to ensure product quality and safety. Single-use solutions can potentially increase a CMO’s flexibility and responsiveness and, thus, the potential benefits seem to align the CMO and the client’s goals. PTE out of their product, but an industry-wide consensus to define the requirements of single-use products in pharmaceutical manufacturing has yet to be established. One suggestion would be to have a standard published that sets out the minimal requirements for established product compatibility using single-use systems, based on an agreement between single-use technology manufacturers Based on a contribution by Mark Kruszynski, Senior Principal Engineer, Technical Transfer at Baxter. To read the full version of this article, go to www.pharmtech.com/kruszynski www.baxter.com 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/kruszynski http://www.baxter.com

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