The Orphan Drug White Paper provides a description of the history and content of the Orphan Drug Act including various statistics through 2005. The paper also describes the orphan drug designation and orphan drug grant processes in sufficient detail for applicants to be able to file an orphan drug designation or grant request.

With the number of color measuring instruments on the market, how do you choose the most appropriate one? It helps to understand the difference between measuring color and measuring appearance.

It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical. Organizations must analyze everything from total protein production level to glycosylation patterns as well as overall quality and stability. Given the large numbers of variables involved—especially in the composition of media nutrients—it is has been difficult to achieve globally optimal conditions using traditional analysis methods. This paper provides an overview of the type of relevant information that global biochemical profiling (metabolomics) can provide. Through this global analysis, one can not only measure these changes but also put them into biological context and—most importantly—into application.

This article discusses the advantages of using a tablet as a standard for Karl Fischer titrations, and compares the results obtained using a tablet standard with those from two other commercial standards based on other delivery systems.

Preparing a regulatory submission document can be costly in regards to resources and time. It is important to follow project management principles to ensure a cost effective and successful submission. This paper provides a summary of the overall process for managing a regulatory submission project.

Magnetic mixers are known to offer significant processing advantages over other types of mixers. This white paper touches on those differences, but focuses heavily on the differences between the different magnetic mixer designs. It highlights some of the most common issues with magnetic mixing, and how one mixer has overcome these issues.

This paper attempts to identify some of the specifics of the process used to obtain approval for use of plastic pallets as equivalent to wood pallets for use in warehouse storage. This paper is written to look at the issue in general and is not intended to cover all storage situations. Your specific situation should be evaluated by a fire protection specialist.

Powder characterization techniques have improved significantly in recent decades, developing well beyond the simplistic methods traditionally used. This paper examines the changes in approach encouraged by QbD and the contribution modern powder testers can make.

Final bulk inspection of solid-dose OTC and regulated pharmaceuticals must deliver consistently high product quality. Customers scrutinize products closely, and processes are increasingly coming under the review of regulatory agencies. Advanced technology addresses these challenges, as new automated continuous inspection systems are more effective and commercially viable than ever before.