Application to the Pharmaceutical Industry

The goal of this chapter is to provide a brief overview of standard engineering methods for process development and scale-up and discuss their applicability to the pharmaceutical industry. Model-based design methods and their impact on optimization, scale-up, and process control are discussed. The state of the art is contrasted to a realistic desirable state where these methods become part of a new standard of technological articulation. 

Browne LJ, L.Taylor L. Predictive chemoinformatics Applications to the pharmaceutical industry. Drug Discov World 2002 2-8. 

TLC has extensive application to the pharmaceutical industry in all areas of drug development synthesis, separation, drug screening, batch quality, government monitoring, and regulations. TLC is used for both licit and illicit drug detection. 

Schacht, W.H. Thomas J.R. Patent law and its application to the pharmaceutical industry an examination of the Drug Price... 

The pharmaceutical industry is precisely one of the sectors in which patents have most impact. The general arguments that are formulated on the subject of technical information are fully applicable to the pharmaceutical environment. Thus in Spain, for example, pharmaceuticals are the third sector in terms of investment, behind automobiles and food. The two questions we must ask are whether there would be less investment and poorer results if patents did not exist, and to what extent results are achieved with the existing patent protection. Nevertheless, these two questions are not easy to answer. Furthermore,... 

With regard to application in the pharmaceutical industry, palladium-catalyzed coupling reactions offer the opportunity of shorter and more selective routes for a number of currently marketed and future drugs. Therefore, it is not surprising that since the early 1990s more and more palladium-catalyzed reactions are transferred from academic protocols to the industrial context (Beller et al. 2001 Beller and Zapf 2002 de Vries 2001). Selected examples of processes that are used nowadays or have been used in the pharmaceutical industry are shown in Scheme 3. In order to see more realizations of this type of chemistry, more active and productive palladium catalysts have to be developed because of the high price of palladium and most often the ligand system. 

Online SPE LC/MS/MS is commonly used for bioanalytical applications in the pharmaceutical industry. Column switching systems and TFC systems are easy to build and control. Sophisticated commercial systems and SPE cartridges are readily available. Compared to offline sample preparation, the online approach can save time and labor. However, the development of online SPE bioanalytical assays remains analyte-dependent. Generic methods can be applied to many analytes. For extremely hydrophobic, hydrophilic, and ionic analytes at normal pH range and analytes with a variety of hydrophobicity and pKa values, analyte-specific methods must be developed. An understanding of the chemistry of the analytes and SPE is critical. 

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

The best practices for the successful implementation of process analytics applications are common to all industries. There are, however, differences in the business model (driver), technical and particularly regulatory areas that are unique to the pharmaceutical industry. The following section seeks to briefly outline these distinctions. 

The first part of this chapter (Section 15.2) discusses the value of and challenges involved in implementing NIR technology in the chemical industry. It also describes a process for successful process analyzer implementation. Similar issues as they relate to the pharmaceutical industry are covered in Chapter 2. The second part of this chapter (Section 15.3) gives a number of examples of actual NIR applications in the chemical industry, which serve both to illustrate the points from the first part and to demonstrate the range of applications for NIR technology. 

For groups experienced in trace analysis of chemical markers for bacteria, currently samples are analyzed almost exclusively by GC-MS/MS. GC-MS/MS assays are now well established and a wide range of clinical and environmental samples have been analyzed. However, application in the pharmaceutical industry requires further evaluation. For example, Mur is released by hydrolysis and analyzed as an alditol acetate 3-OH FAs after methanolysis are converted to methyl trimethylsilyl derivative. Detailed analytical procedures have been described elsewhere for Mur [3,4,7, 8,11] and for 3-OH FAs [2, 5,12,13]. The compounds of interest contain active... 

Investigational New Drug Application (IND)—The pharmaceutical industry sometimes provides advice to the FDA prior to submission of an IND. Sponsors—companies, research institutions, and other organizations that... 

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