BioPharm International Supplements, November 2006 - BioPharm International

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BioPharm International Supplements, November 2006
Articles
Disposables in the Quality Control Laboratory
By Steven S. Kuwahara
The deliberate reuse of disposables has caused many clinically significant problems.
Disposable Biopharmaceutical Processes–Myth or Reality?
By Keith DiBlasi , Maik W. Jornitz , Uwe Gottschalk, PhD , Paul M. Priebe
Biopharmaceutical processes typically require a significant investment in equipment—often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.
Properties of Materials Used in Single-Use Flexible Containers: Requirements and Analysis
By Magali Barbaroux , Andrew Sette
The adoption of single-use containers in the biopharmaceutical industry is becoming more frequent as the popularity and availability of the technologies increase. The choice of a solution for storage in single-use containers clearly depends on the application and the inherent risks associated with the application. A "one fits all" single-use system cannot respond to all the requirements of a particular step in a biopharmaceutical process, much less to all the steps of a process. The needs of an application will lead to very specific single-use solutions.
Successful Project Management for Implementing Single-Use Bioprocessing Systems
By Miriam Monge
In its early days, the biotech industry was almost entirely science driven, but it has since expanded from a laboratory environment to a sophisticated and dynamic manufacturing environment. As technological discoveries are increasingly translated into commercial products, biotech companies are realizing that they must generate a stronger return on assets.
Simplifying Validation of Disposable Technologies with Presterilization by Gamma Irradiation
By Hélène Pora
Filtration systems exemplify disposable technologies that can be presterilized.

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