Pharmaceutical industry contract manufacturer

Within the chemical universe, the fine-chemical industry is positioned between the commodity and specialty chemical industries. They are their suppliers and customers, respectively. Among the latter, the life sciences, especially the pharmaceutical industry, prevail (see Section 9.2). A large variety of enterprises, laboratories, and institutes in both the private and public sectors are providing contract research and manufacturing services along the drug supply chain (see Figure 2.1). 

With respect to the pharmaceutical industry, outsourcing and contract manufacture probably got its start with APIs, final and key intermediates, and other steps... 

Reproducibility encompasses the variation in analytical results between laboratories and provides a second level of method ruggedness. This is becoming an increasingly important part of method validation as the pharmaceutical industry becomes more specialized and diversified. Major manufacturers may develop and validate a method in a corporate research center for use in a foreign manufacturing site or at a contract testing laboratory. It is therefore critical that the validation demonstrates that the method is free of analyst or instrument bias. 

Contract and manufacturing services for the pharmaceutical industry, including encapsulation, fluid bed processing, granulation, mixing/blending, etc.)... 

A vast industry, including CROs, fine chemicals manufacturers, biotechnology companies, equipment suppliers, human resource providers, softwaie developers and contract manufacturers is providing an increasing variety and increasing shaie of the pharmaceutical industry s activities. 

Biocatalysts Ltd. is an independent company that since 1980 has been devoted to the manufacture and sales enzymes. Since it is not part of a larger chemical, food ingredients or pharmaceutical company, instead of producing large volumes of commodity enzymes, it produces enzymes tailored to customer needs. Their services include working together with customers to industrialize their processes or to produce specific required enzymes. Usually, these customer sectors do not require single enzyme entities, but enzyme complexes where the ratios of each of the components are crucial to the efficacy of the whole enzyme-biocatalyst product and to the customer s process. Fermentation requirements for the manufacture of enzyme products are sub-contracted out. 

This sale and back-lease model is applied by many other pharmaceutical companies. It enables the company to dispose of assets without being forced to lay off employees. The net effect for the industry as a whole is that statistically, the share of outsourcing is increasing. However, the problem of underutilized capacity persists. For a hne-chemical company, the acquisition of an API plant from a pharma company is problematic. Once the supply contract, offered by the pharma company as an incentive for the acquisition, expires, the problem arises as to what the capacity should be used for. This is all the more the case as the plants usually are designed to manufacture just one product and therefore are not truly multipurpose. Last but not least, the plants have been run as cost centers and the implementation of a lean production... 

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