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forced all companies to examine the development process to improve efficiency, cost-effectiveness and shorten lead times. One area of significant improvement has been project management in product development. More attention is being paid to integrating R & D activities worldwide to reduce development times and improve the focus on commercial outcome. Improving the coordination of preclinical, clinical, and technical activities is now well in hand in most organizations, and great strides are being made in planning and executing development programs. In addition, it has been acknowledged that better integration of R & D and Marketing is needed to ensure that development targets areas of greatest commercial interest and scientific feasibility. R & D and Marketing have, therefore, worked more closely integrating their activities at portfolio and project level to optimize the chances of a stream of products which meet the company's financial objectives. |
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The improvement in the development process has undoubtedly been focused primarily on R & D and Marketing. Although this has strengthened product development considerably, it still falls short of a complete overhaul of the process to fully integrate all functions into the product development effort. An area that still needs to receive full attention is Manufacturing. The question is why? It could be argued that this has been caused by an attitudinal problem on both sides of the equation. In the past Manufacturing has essentially been seen and has seen itself as a reactive function which has to deal with the outcome of development but does not influence the process itself. In the past when prices and margins have been high, there was less incentive to examine the cost and manufacturability of the products throughout the development process. However, in the last ten years this approach has come under increasing challenge for a number of reasons. The main ones are the following: |
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As development programs are shortened, the scale-up of primary and secondary processes has to be more rapid to meet the demands of a large development program. |
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More process validation data are being demanded by authorities to demonstrate that there is a well-controlled and well-understood process. Nowhere is this more true than in the biotech field where the process and the product are essentially one and the same, and controls to demonstrate a reproducible and robust process are essential for eventual approval of the product. Preparation for the Preapproval Inspection at the site of manufacture also places more demands on the manufacturing team. |
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