Biopharmaceutical industry

The Federal Drug Administration (FDA) describes the biopharmaceutical industries as self-regulated, retaining for itself the responsibility of assuring and checking on that self-regulatory process. Not surprisingly, then. 

WoRZ, O., Jacket, K. P., Richter, T, Wole, A., Microreactors, new efficient tools for optimum reactor design. Microtechnologies and Miniaturization, Tools, Techniques and Novel Applications for the BioPharmaceutical Industry, IBC Global Conferences, London (1998). 

Recent developments in drug discovery and drug development spurred the need for novel analytical techniques and methods. In the last decade, the biopharmaceutical industry set the pace for this demand. The nature of the industry required that novel techniques should be simple, easily applicable, and of high resolution and sensitivity. It was also required that the techniques give information about the composition, structure, purity, and stability of drug candidates. Biopharmaceuticals represent a wide variety of chemically different compounds, including small organic molecules, nucleic acids and their derivatives, and peptides and proteins. 

The initial driving force behind the development of HPCE came from the need of better and faster separations for biologically important molecules used in biotechnology research and in the biopharmaceutical industry. Traditional electrophoresis is an established method in life sciences however,... 

Frost, Sullivan, Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Frost Sullivan, London, 2003. 

This technique is also utilized in the biopharmaceutical industry to determine product homogeneity. Homogeneity is best indicated by the appearance in the gel of a single protein band, exhibiting the predicted pi value. Interpretation of the meaning of multiple bands, however, is less straightforward, particularly if the protein is glycosylated (the bands can also be stained for... 

In the development of new biopharmaceutical molecules, there is a constant need for analytical methods that provide critical information in areas that range from early characterization to routine analysis of approved products. Past experience indicates there are few projects in drug development that can be addressed by standard analytical procedures. Even well-established techniques often have to be modified to better suit the analysis of new samples. For this reason, a broad range of techniques is already an integral part of laboratories in the biopharmaceutical industry. 

NMR is a remarkably flexible technique that can be effectively used to address many analytical issues in the development of biopharmaceutical products. Although it is already more than 50 years old, NMR is still underutilized in the biopharmaceutical industry for solving process-related analytical problems. In this chapter, we have described many simple and useful NMR applications for biopharmaceutical process development and validation. In particular, quantitative NMR analysis is perhaps the most important application. It is suitable for quantitating small organic molecules with a detection limit of 1 to 10 p.g/ml. In general, only simple one-dimensional NMR experiments are required for quantitative analysis. The other important application of NMR in biopharmaceutical development is the structural characterization of molecules that are product related (e.g., carbohydrates and peptide fragments) or process related (e.g., impurities and buffer components). However, structural studies typically require sophisticated multidimensional NMR experiments. 

Atun RA, Sheridan D, eds. Innovation in the Biopharmaceutical Industry, World Scientific, Singapore, 2007. 

In the last two decades, CE has advanced significantly as a technique for biomolecular characterization. It has not only passed the transition from a laboratory curiosity to a mature instrument-based method for micro-scale separation, but has also emerged as an indispensable tool in the biotech and pharmaceutical industries (Chapter 14). CE has become a method of choice in R D for molecular characterization, and in QC for release of therapeutic biomolecules. In the biopharmaceutical industry, more and more CE methods have been validated to meet ICH requirements. To demonstrate the influence of CE in RScD for method development and in manufacturing for the release of therapeutic proteins and antibodies, examples from the pharmaceutical industry are provided in Chapter 14. 

A major change in the biopharmaceutical industry is the imminent entry of generic firms. Between 2001 and 2006, biopharmaceuticals with a total market of over 13 billion went off patent. 

Selman Waksman s commitment to the isolation and screening of soil bacteria in the search for bioactive small molecules, especially potential antibiotics, was validated by the discovery of streptomycin. This led to the creation of the modem biopharmaceutical industry and the subsequent isolation of tens of thousands of bioactive small molecules from soil bacteria and other environments. A proportion of these compounds have become highly successfnl therapeutics, not only for all types of infectious diseases, but also in the treatment of many other human and animal ailments and as anticancer, immnno-modnlatory, and cardiovascular agents. Waksman and Fleming could be considered the fathers of chemical biology (Figure 1.1). 

The term system or quality system is used with surprising inconsistency throughout the pharmaceutical and biopharmaceutical industry and by government regulators. Even within a single company or within a department, the terms can be nebulous in their use and interpretation. System is often used to describe an individual process or unit operation. Often, the term system is used so narrowly as to describe an individual policy, standard, or even a single procedure. 

Often, the best examples of process efficiency can be found outside the pharmaceutical and biopharmaceutical industries. Other fields such as electronics, space, and software industries have evolved their documentation, training, quality, and change control systems to the point of best in class. These industries are more time sensitive to get product to market and have often evolved their processes to be efficient and decision processes to be very quick. Process owners may expand their knowledge by investigating other industries to find best practices and apply them internally. 

Meltzer, T. H., Jornitz, M. W. Filtration in the Biopharmaceutical Industry. New York Marcel Dekker (1998). 

The analytical capability of MS has been evolving at an astounding rate as Nobel laureates and developers push what is an inherently powerful analytical technique to even higher levels of capability. During the last decade, numerous ionization and analyzer configurations have been commercialized. Some of the most recent developments have made MS the gold standard for many pharmaceutical analyses, and has made the biopharmaceutical industry the major purchaser of mass spectrometers (Cudiamat, 2005). 

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