Technical Aspects of Product Development

Medicinal products must have a consistent quality in order to be reliably effective and safe. Achieving consistency in all aspects is a cumbersome technical and analytical task which takes much time and which is usually not the main virtue of research work. Scientists without experience in product development tend to neglect the technical aspects which lead to a consistent product quality. 

Increasing registration requirements for the product and the production process as well as environmental issues also add a significant technical and analytical dimension to the development. This particularly applies to products derived from biotechnology. Compared to conventional biological products, the final product is usually much better defined and its manufacturing process can be better controlled. But it requires the application of a variety of quite sophisticated techniques to do so. 

For most new biotechnological products, processes and analytical methods have to be newly established. This represents a major and costly part of product development. In newly founded biotechnology firms pertinent technical experience and practical knowledge about the application of regulatory requirements is usually missing and must be developed. Early information and consideration of these aspects may considerably shorten this learning process. 

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M. Myrup Andreasen and Lars Hein Integrated Product Development, Institute for Product Development, The Technical University of Denmark, 2000 (published earlier by Springer) tells why the different aspects of product development have to be done simultaneously. Very readable. 

The pilot plant and its staff play a critical role in technology evaluation, scale-up, and transfer activities of new products. These activities begin early in the development cycle and include technical aspects of process development and scale-up, organization and responsibilities of technology-transfer teams, documentation of the transfer process, and often preparation for an FDA pre-approval inspection (PAI). A properly designed and operated pilot plant can enhance the collection of scientific data necessary to support internal transfer activities, as well as regulatory submissions and FDA PAIs.P ... 

Technologists are supposed to work in that part of the engineering spectrum which lies between the engineer and the technician, in the routine aspects of product development, manufacturing planning, construction supervision, or technical sales. However, as is often the case, individual... 

This section mainly addresses the purpose and technical aspects of preclinical studies which are described and recommended in the registration guidelines of the EEC, Japan and the USA. The following brief descriptions of commonly used test procedures cannot replace the detailed study of guidelines by those who conduct these trials. They are intended to give the less experienced an idea about the safety standards, which have to be fulfilled by a medicinal product and about the purpose and conduct of these tests. This enables scientists in research and development to judge essential parts of a project for themselves and to make better and informed decisions. It also assists in planning time and cost of a project. 

FIGURE 8.1 The V-Model covers the entire process for software development from the business requirements to the implementation of the software in its intended operational environment. The process starts with a statement of work that defines the effort reqnired for the design, engineering, development, production, and test, and prototyping of a software system. The software documentation process covers user requirements, functional, and technical aspects of the software development. After development, different test phases are performed to verify installation, operation, and performance of the software. A business acceptance from the customer finally leads to implementation of the software. 

The use of catalytic methods for the technical preparation of agrochemicals is illustrated by the case history of the herbicide metolachlor (trade name DUAL ), the most important herbicide for maize. The key step for the technical synthesis of the racemic conqx>und is a reductive alkylation catalyzed by a Pt/C catalyst in presence of sul ric acid. The commercial production of the biologically active S-enantiomers was made possible by the development of a new Iridium ferrocenyl-diphosphine catalyst system. Inqxirtant aspects of the development of the two catalyst systems as well as important prerequisites for the use of catalysts for the production of agrochemicals are discussed. 

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