In the biological arena, new and highly useful fluorescent markers are used to stain or 'label' specific structures of interest. They have transformed the range and applicability for optical observation. These labels are excited and correspondingly emit at specific wavelengths; thus, different facets of a specimen can be 'selected' by controlling the wavelength of the delivered and captured light. For example, labels such as 4',6-diamidino-2-phenylindole (DAPI) are used to highlight the nucleus of a cell and MitoTracker Orange is used for mitochondria. Figure 1 shows an example of a multiple stained section, viewed in fluorescence. There has been an explosion in fluorescent labels for examining biological structures, in fixed and live cell preparations.
High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.
An electronic object-based approach towards validation is forecasted to be the upcoming validation paradigm supported by reliable web-based technology, organizational focus on risk management and overall enterprise effectiveness.
In 2007, the global pharmaceutical market is expected to grow moderately while biologics, generic drugs, and specialty-initiated drugs are projected to increase at double-digit rates. These trends for finished pharmaceuticals are reflected in the global market for APIs, where the merchant generic API market is expected to see strong demand. On a production basis, India and China are forecast to raise their shares of the global generic API market against industry strongholds Italy and Spain. Meanwhile, the US is expected to hold its its position as the leading producer of biotechnology-based APIs in an area traditionally dominated by captive production. And biogenerics or biosimilars gradually reshape the market.
The completion of the Human Genome Project in 2003 led to a flurry of predictions regarding the application of pharmacogenomics to drug development. With US and European regulatory authorities finally on the verge of issuing guidance on the use of pharmacogenomics, drug development is all set to change.
Last year, a monoclonal antibody, TGN1412, led to potentially fatal adverse effects in a small group of Phase I volunteers in London. In the wake of this incident, EMEA has drawn up new guidelines that could lead to demands for more data on novel biologics. They may have implications for both manufacturing and clinical trials of biopharmaceuticals that are considered to pose a high risk to patients.
The scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.
The authors consider the advantages of using rapidly dissolving films to accurately and effectively deliver pharmaceutical ingredients, with an emphasis on the importance of controlling moisture content and drug loading during formulation development.
Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.