Drug development manufacturing

Drug substance/drug product manufacturing process development, validation, and transfer... 

R D Focus. This database service [66] provides information on over 7000 drugs in active development. The service monitors the development, efficacy, and status of pharmaceuticals from early clinical testing through to launch. Data are gathered through direct contact with manufacturers and research organizations. It appraises both the scientific and commercial aspects of drug development and is searchable by product, by phase, by mechanism of action, and by country. R D Focus product is commercially available in several formats. 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Regulatory and legal aspects of drug development, 27. Industry Profile, Pharmaceutical Research and Manufacturers of America, Washington, DC, 2000, pp. 22-47. 

The business of BioZone Laboratories concerns development, manufacturing, and marketing of products and technologies, such as drugs and preparations, cosmetics, and nutritional supplements. All product lines are supported by proprietary technologies, and research and development activities are considered to be of a core importance for the business. The IP estate is also available for commercialization, particularly in the prescription area, for which several drug delivery systems and a prescription version of Inflacin were developed. 

Master and working banks of both the viral vector and the animal cell line will have been constructed during the drug development process (see Chapter 4). Manufacture of a batch of vector, therefore, will be initiated by the culture of packing cells in suitable animal cell bioreactors. The... 

The use of BRMs to treat human disease has its origins in the use of bacterial toxins to treat cancer by William B. Coley.73 These early studies resulted in the use of microbi-ally-derived substances such as BCG, Picibanil, carbohydrates from plants or fungi such as Krestin and Lentinan, other products such as Biostim and Broncho-Vaxom, as well as thymic extracts (Table 9.4). However, the lot-to-lot variation in the manufacture of these drugs has dampened enthusiasm. Equally, the focus on MOAs in drug development strategies has also dampened developmental efforts. The particulate nature of some BRMs can also result in pulmonary thrombosis and respiratory distress following i.v. injection. However, BRMs are commonly used to treat bladder cancer and derivatives of natural products are routinely used clinically. 

Anon. (1998a). Annual Report of the Pharmaceutical Research and Manufacturer s Association. (Priority 2 Improved FDA Regulation of Drug Development). 

FDA. Guidance for Industry PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER),... 

Examples of PAT applications to drug development are a crystallization process optimization from laboratory to industrial scale [72] optimization of manufacturing steps in pharmaceuticals [70]... 

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical... 

Many literature sources describing formulation and manufacture of different pharmaceutical dosage forms are available.10,11 The primary objective of this chapter is to describe an integrated process of drug development, demonstrating how all activities from lead selection to LCM are interrelated. Various scientific principles underlying these activities are described. 

Combined with the trend of small niche companies in drug development has come the parallel corporate trend of downsizing and the hesitancy to expand divisions to take on temporary projects. A great number of large companies are contracting for critical aspects of drug discovery and development. Compounds can be manufactured xmder contract. 

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