Identifying issues in the factory that traditionally arise in the field minimized onsite equipment rework and subsequent qualification work.Risk is part of biopharmaceutical development. Planning for commercialization typically starts after completion of phase 1 trials. If you wait until the end of phase 3 to build a manufacturing facility, years of profitable sales will be lost. If you build a factory too early, you risk the possibility that the factory will be idle while waiting for product approval. After all, in today's regulatory and economic climate, the odds of successfully bringing a product from discovery through clinical development to commercial success are less than 1 in 100. Companies cannot be blamed for questioning when, or even if, they should build a new facility to manufacture a product for commercial launch. However, modular design can reduce this risk by reducing construction time and increasing flexibility.
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