One of the most important steps in bringing any pharmaceutical product to market is designing and developing a robust manufacturing process that can reliably create a product that meets customer needs. Significant challenges can occur when scaling a product from the lab bench to commercial scale manufacturing and a poorly designed manufacturing process can compound these issues. These problems should be caught during process qualification or pilot manufacturing; however, an optimal system is for manufacturers to develop their processes based on sound science and robust procedures.
Kymanox uses industry best project management and quality management tools and expert knowledge to help companies in all stages of process development, ensure their manufacturing systems have quality by design (QbD). Having a well-developed process is important because it reduces the variability between batches and ensures that the drug tested in clinical trials has the same attributes as the drug manufactured. Furthermore, a robust manufacturing process will not only provided added assurance of product quality, but will reduce manufacturing costs over the lifecycle of the product.