Abstract: Surface analysis using grazing-angle FTIR spectroscopy provides an in-situ, real-time method for cleaning validation. Recent trials at three manufacturing facilities show that the method works well under real-life conditions.

In-situ FTIR spectroscopy using a sterilizable sampling head is an ideal method for monitoring bioprocesses such as mammalian cell cultures, making it possible to track nutrients and waste products in real time.

In-situ FTIR spectroscopy provides a direct view of the "vital signs" inside a fermenter. Tracking dissolved carbon dioxide is an important part of this monitoring method.

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.

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.

The characterization of complex polyclonal anti-HCP antibodies has traditionally been accomplished by 2 dimensional Western blot as correlated to a non-specific silver stain. We discuss the limitations of this method and suggest 2D HPLC fractionation of HCPs followed by ELISA detection as a much more sensitive, specific, and quantitative method to detect individual HCPs. This paper shows data comparing the 2 methods on both an upstream and final drug substance sample.

The biotechnology industry has mushroomed over the past decade, with revenues increasing from $8 billion in 1992 to $39 billion in 2003,1 and it shows no signs of slowing down. New therapeutics are entering and pressing through clinical trials. Treatments are emerging from clinical trials ready for marketing and scaling up for commercial production, leading to a growing need for new facilities.

Within the human body many circulating proteins are glycosylated, and therefore the most promising candidate drugs for biopharmaceutical use have glycan chains. The oligosaccharide components can directly affect the efficacy and safety of these drugs by influencing binding, immunogenicity, and turnover. It is, therefore, critical to characterize oligosaccharide structure in biopharmaceutical development.

Biopharmaceutical companies are requiring their analysts to screen increasingly larger quantities of monoclonal antibody samples to support clone selection, stability, and product formulation studies. In this study, we have combined a quadrupole-based LC/MS system, the ACQUITY SQD, with robust methodology, using the MassPREP Micro Desalting Column, for rapid sample desalting and efficient variant profiling of reduced monoclonal antibodies.