Manufacturing Scale Up

Scale up is the process in which the batch size is increased. This is a process that may be repeated several times during the life cycle of the product. For many drugs, the first scale-up occurs following a successful preclinical trial, when the small-scale laboratory batches are insufficient to support the phase I trial demands.  

A successful scale-up will ensure that the process will yield a consistent product, that will meet all the specifications and Target Product Profile requirements. Therefore, careful planning of the process is required in order to minimize the challenges ahead. Once the scale-up batch is manufactured it will be tested to ensure that it meets the specifications of the original product.

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          Tip from our scientists

One of the factors that may help you go through the scale up process smoothly is the development of an appropriate formulation. An experienced formulator will consider the future need for larger batches and will choose the appropriate ingredients and preparation processes that will enable it.