Stages of New Process Development
In today’s competitive pharmaceutical market, a good product strategy and careful planning are vital to succeed. Pharma companies are competing on all fronts to develop innovative products to gain an upper hand in the market. Often these products fail to secure an advantage and end up being just another high cost centre for the company. Thousands of clinical studie are being carried out as we speak, but only a few drugs get approval. In other words, the success rate of drugs under experiment making it to the shelves of a drug store or your medicine cabinet is quite low. This low success rate puts a lot of pressure on firms to keep a large set of products in the pipeline, thus increasing demands on process development groups to lower time-to-market and time-to-clinic. Additionally, the recently approved proteins are monoclonal antibodies that will need lifetime doses 10-100 times bigger than various recombinant protein drugs. Drug process development is not ...