Pharmaceutical Technology Europe - October 2010 - (Page 10)

The pros and cons of single-use bioreactors The willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production. bioreactors almost completely eliminate these problems. Additionally, single-use bioreactors provide maximum savings on the time spent to prepare the system for the next batch. As an example, a 2-h changeover time with a single-use bioreactor would equate to a changeover time of 6–10 h with a stainless steel bioreactor for the same product, and 3 weeks for a full product changeover. future development in single-use bioreactor technology will be the increase in capacity to match common large-scale process capacities. Single-use bioreactor customisation will also mark a significant innovation, whereby the bioreactor system will fit into the existing space without compromising process requirements. PTE Advantages Single-use bioreactors are considered safe, simple and clean, and the possibility of batch-to-batch contamination by adventitious microorganisms or through product cross-contamination is significantly controlled. One of the biggest advantages of such systems, however, is flexibility. The increasing trend towards multi-drug facilities demands the production of different drugs using the same facility, with minimum time and cost. In such situations, the main manufacturing bottleneck is line clearance and cleaning validation. Single-use Salvadi S. E aswaran Obstacles to adoption There are also some key challenges associated with single-use bioreactors. In particular, such systems are non-customisable (since customisation would defeat their key advantage of plug and play) and can provide challenges when it comes to scale-up since the volume size is restricted (<2000 L). Disposal can also be a problem. In many cases, single-use bioreactors are produced from plastic derivatives. In addition to validation concerns related to potential leachable and extractable materials, the large-scale disposal of such plastic reactors on a regular basis is also an environmental concern. This is a key challenge, particularly in countries where the disposal of plastics is strictly controlled. Based on a contribution by Salavadi S. Easwaran, Technology Manager-PMT, at Merck Millipore, India. To read the full version of this article, go to www.pharmtech.com/easwaran www.merck.de Future innovations In the future, the most important 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/easwaran http://www.merck.de

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